Proactiveinvestors Australia Paradigm Biopharmaceuticals Ltd https://www.proactiveinvestors.com.au Proactiveinvestors Australia Paradigm Biopharmaceuticals Ltd RSS feed en Thu, 23 May 2019 13:53:53 +1000 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Paradigm Biopharmaceuticals completes retail component of $26.3 million entitlement offer ]]> https://www.proactiveinvestors.com.au/companies/news/219926/paradigm-biopharmaceuticals-completes-retail-component-of-263-million-entitlement-offer-219926.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has raised about $16.15 million at $1.50 per share, completing the retail component of its one-for-eight accelerated non-renounceable entitlement offer.

The retail entitlement offer, which is fully underwritten by Bell Potter Solutions Limited, closed on May 6, 2019 and together with shares issued under the institutional component of the entitlement offer, the total amount raised will be about $26.3 million.

READ: Paradigm Biopharmaceuticals completes institutional component of $26.3 million entitlement offer

The shortfall under the entitlement offer will rank equally with existing shares on issue.

Shares issues under the retail entitlement offer are expected to be issued on May 13, 2019 and will be allotted and quoted on the ASX on May 14, 2019.

Last Month Paradigm completed the institutional component of the fully underwritten accelerated non-renounceable entitlement offer raising about $9.8 million.

The new funds will allow the company to advance its pivotal phase 3 OA clinical trial in the US, EU and Australia as well as to complete the phase 2/3 pivotal clinical trial in MPS.

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Thu, 09 May 2019 11:19:00 +1000 https://www.proactiveinvestors.com.au/companies/news/219926/paradigm-biopharmaceuticals-completes-retail-component-of-263-million-entitlement-offer-219926.html
<![CDATA[News - Paradigm Biopharmaceuticals completes institutional component of $26.3 million entitlement offer ]]> https://www.proactiveinvestors.com.au/companies/news/218998/paradigm-biopharmaceuticals-completes-institutional-component-of-263-million-entitlement-offer-218998.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has successfully completed the institutional component of its fully underwritten accelerated non-renounceable entitlement offer to raise about $9.8 million.

The retail component of the entitlement offer will open today and is expected to raise about $16.5 million, providing a total equity raising under the entitlement offer of about $26.3 million.

Retail entitlement offer

Eligible shareholders may participate in the retail entitlement offer at the same price ($1.50 per share) as the institutional offer at an offer ratio of 1 new share for every 8 shares held.

The retail entitlement offer closes at 5.00pm (AEST) on May 6, 2019.

READ: Paradigm Biopharmaceuticals raising $77.9 million to fund its pivotal phase 3 OA trial

Along with the entitlement offer, Paradigm has raised $51.6 million via a placement to professional, institutional and sophisticated investors across Australia, Asia and the US.

The new funds will allow Paradigm to advance its pivotal phase 3 OA clinical trial in the US, EU and Australia.

The funds will also be used to complete the phase 2/3 pivotal clinical trial in MPS.

READ: Paradigm Biopharmaceuticals phase 2b trial achieves key endpoints in OA of the knee

The company has already successfully achieved the endpoints of improved knee function and pain reduction for its phase 2b trial in OA of the knee.

The clinical trial subjects receiving Paradigm’s injectable pentosan polysulfate sodium (iPPS) were shown to have reduced bone marrow lesion (BML), indicating the possible regression of the disease.

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Wed, 24 Apr 2019 14:19:00 +1000 https://www.proactiveinvestors.com.au/companies/news/218998/paradigm-biopharmaceuticals-completes-institutional-component-of-263-million-entitlement-offer-218998.html
<![CDATA[News - Paradigm Biopharmaceuticals director buys shares on-market ]]> https://www.proactiveinvestors.com.au/companies/news/218985/paradigm-biopharmaceuticals-director-buys-shares-on-market-218985.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) non-executive director Christopher Fullerton has purchased $32,130 worth of shares through on-market trades.

The 19,500-share purchase at an average price of $1.647 increases his overall holding to 855,500 shares.

Notably, this purchase price was done at a premium to the recent capital raising offer price of $1.50.

READ: Paradigm Biopharmaceuticals secures $61.3 million in first stage of raising

The capital raising will raise $77.9 million and comprised of a $61.3 million institutional component, which is complete, and a $16.6 million retail component which opens today.

Paradigm’s chairman Graeme Kaufman said in a letter to shareholders earlier this week: “It is anticipated that they will be applied, in conjunction with the Placement funds, to fund the company’s osteoarthritis and MPS (rare disease) programs through to end of their pivotal phase 3 studies, new drug applications, working capital, costs of offer, further preclinical studies and possibly further intellectual property acquisitions.”

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Wed, 24 Apr 2019 08:33:00 +1000 https://www.proactiveinvestors.com.au/companies/news/218985/paradigm-biopharmaceuticals-director-buys-shares-on-market-218985.html
<![CDATA[News - Paradigm Biopharmaceuticals secures $61.3 million in first stage of raising ]]> https://www.proactiveinvestors.com.au/companies/news/218723/paradigm-biopharmaceuticals-secures-613-million-in-first-stage-of-raising-218723.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has secured $61.3 million in funding from the institutional component of its rights issue and placement priced at $1.50.

An additional $16.6 million is expected to be raised through the retail component of the rights issue, which will open next Wednesday 24 April 2019.

This will take the total capital raising to $77.9 million as outlined earlier to the market on Monday.

READ: Paradigm Biopharmaceuticals raising $77.9 million to fund its pivotal phase 3 OA trial

Paradigm’s managing director Paul Rennie said: “On behalf of the board we delighted with the overwhelmingly positive response to the release of the osteoarthritis phase 2B secondary endpoint data (on 15 April) and this capital raise.

“The board believes that Paradigm has now secured funding for purposes including the conclusion of our pivotal phase 3 clinical trials for OA and MPS.

New international investors on board

“I take this opportunity to welcome new institutions from the UK, USA, Asia and Australia to the register and to thank our existing shareholders for their ongoing support.

“From a clinical perspective I note the significance of the indicative regression of disease demonstrated by our secondary endpoint data.

“With this combination of funding and compelling clinical data the company is well placed to progress its clinical program whilst pursuing potential commercial transactions.”

READ: Paradigm Biopharmaceuticals phase 2b trial achieves key endpoints in OA of the knee

On Monday this week, the company also revealed that it had successfully achieved the secondary endpoints of improved knee function and pain reduction for its phase 2b trial in OA of the knee.

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Wed, 17 Apr 2019 10:39:00 +1000 https://www.proactiveinvestors.com.au/companies/news/218723/paradigm-biopharmaceuticals-secures-613-million-in-first-stage-of-raising-218723.html
<![CDATA[News - Paradigm Biopharmaceuticals phase 2b trial achieves key endpoints in OA of the knee ]]> https://www.proactiveinvestors.com.au/companies/news/218542/paradigm-biopharmaceuticals-phase-2b-trial-achieves-key-endpoints-in-oa-of-the-knee-218542.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has successfully achieved the secondary endpoints of improved knee function and pain reduction for its phase 2b trial in OA of the knee.

The clinical trial subjects receiving Paradigm’s injectable pentosan polysulfate sodium (iPPS) were shown to have:
• improved knee function for 6 months;
• durable pain reduction for 6 months, and
• reduced bone marrow lesion (BML) grade, volume and area at day 53.

Importantly, the reduction of BML signals the possible regression of the disease.

BML before and after the treatment

Paradigm has now successfully met both the primary endpoint and secondary endpoints of its phase 2b trial in OA of the knee.

READ: Paradigm Biopharmaceutical shares surge on clinical trial success

Paradigm CEO Paul Rennie said: “We are pleased with the positive Activities of Daily Living data and the positive objective MRI data being reported today.

“Additionally, the KOOS pain reduction to day 165 demonstrates the potential of iPPS to be a long-lasting and efficacious pain treatment in subjects with OA.

“Traditionally, in OA sufferers, bone marrow lesions remain the same size or get larger over time.

“Here, we see iPPS producing a net 65% reduction in BML Volume in the NRS 4-6 strata, which is impressive, especially considering the MRI images were taken just two weeks after the last injection of iPPS, which is a very short time period after cessation of the drug.

READ: Paradigm Biopharmaceuticals raising $77.9 million to fund its pivotal phase 3 OA trial

“At such an early time-point of Day 53 we were looking for early MRI signals to demonstrate the trend in remission of BMLs.

“To have such a magnitude of difference on the total knee volume and area and statistically significant difference for the medial compartment of the knee is an amazing result and something that the medical, scientific and pharmaceutical fraternity will appreciate the importance of.”

Treating OA without an opioid

OA remains the most common form of joint disease globally. In the US alone, it affects over 30 million adults, while in Australia, arthritis affects around 3 million people.

The demand for a new effective treatment is significantly amplified by the opioid epidemic throughout the US.

Paradigm’s iPPS is neither an opioid nor a steroid and most importantly is non-addictive, thus has the potential to positively impact the opioid epidemic and treat OA pain.

Paradigm believes iPPS has the potential to receive Fast Track designation from the US Food and Drug Administration (FDA), which is greatly concerned about the opioid epidemic.

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Mon, 15 Apr 2019 14:22:00 +1000 https://www.proactiveinvestors.com.au/companies/news/218542/paradigm-biopharmaceuticals-phase-2b-trial-achieves-key-endpoints-in-oa-of-the-knee-218542.html
<![CDATA[News - Paradigm Biopharmaceuticals raising $77.9 million to fund its pivotal phase 3 OA trial ]]> https://www.proactiveinvestors.com.au/companies/news/218535/paradigm-biopharmaceuticals-raising-779-million-to-fund-its-pivotal-phase-3-oa-trial-218535.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has launched a $77.9 million capital raise to fund its pivotal phase 3 OA clinical trial in the US, EU and Australia.

The funds will also be used to complete the phase 2/3 pivotal clinical trial in MPS.

The offer comprises a $51.6 million placement to professional, institutional and sophisticated investors across Australia, Asia and the US including some existing shareholders.

Paradigm is also raising $26.3 million via an underwritten 1 for 8 accelerated non-renounceable entitlement offer to eligible shareholders.

Proposed use of funds

In conjunction with the capital raise, Paradigm has revealed that it has successfully met the primary and secondary endpoints of its phase 2b trial in OA of the knee.

Paradigm will have a cash position of $82 million post the capital raising which will put the company in a strong negotiating position for commercial transactions.

Placement and entitlement offer

The placement will result in the issue of 34,370,099 shares and the entitlement offer will result in the issue of 17,537,431 shares, at an offer price of $1.50 per share.

The offer price represents a 21.1% discount to last close on April 10, 2019.

Settlement of the placement and institutional entitlement offer is expected to occur on April 24, 2019 with new shares allotted the trading next day.

The retail entitlement offer is expected to close on May 6, 2019.

Indicative timetable

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Mon, 15 Apr 2019 12:27:00 +1000 https://www.proactiveinvestors.com.au/companies/news/218535/paradigm-biopharmaceuticals-raising-779-million-to-fund-its-pivotal-phase-3-oa-trial-218535.html
<![CDATA[News - Paradigm Biopharmaceuticals gets a speeding ticket for 18% price increase ]]> https://www.proactiveinvestors.com.au/companies/news/217370/paradigm-biopharmaceuticals-gets-a-speeding-ticket-for-18-price-increase-217370.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has responded to a Price Query from the ASX regarding its run from its $1.605 close Tuesday to $1.90 yesterday, a gain of 18.3%.

The company responded to the ASX saying it was not aware of any relevant information not released to the market.

Paradigm went on to say that it believes a number of factors provide a possible explanation for the recent trading.

READ: Paradigm Biopharmaceuticals director shows confidence with on-market share purchase

Paradigm wrote: “As previously reported, Paradigm Biopharmaceuticals Ltd (ASX: PAR) intends to report on the secondary endpoints to its Phase 2b osteoarthritis randomised, double-blind,  placebo-controlled, multicentred clinical trial (the Phase 2b OA Clinical Trial) in Q1/Q2 CY2019.

“On the 18th and 20th December 2018, Paradigm reported the top-line results to the Phase 2b OA Clinical Trial. The top-line results were positive with the primary end-point being achieved.

READ: Paradigm Biopharmaceuticals moving towards phase 2/3 MPS clinical trial

“At the same time it was disclosed that Paradigm would report the outcome of the Phase 2b OA Clinical Trial secondary endpoints in Q1/Q2 CY2019. As disclosed in the clinical trial protocol, the secondary endpoints that will be reported are:

1. Mean change in KOOS pain score from baseline to day 165 – which measures durability of effect for the drug up to approximately 6 months;
2. Mean percentage change in KOOS Activity of Daily Living (ADL) from baseline to day 165 – which measures daily activities such as walking, going up and down stairs etc;
3. Proportion of subjects with >50% reduction in KOOS pain from baseline to day 165 – which indicates the proportion of subjects receiving a very strong (>50%) clinically meaningful benefit;
4. Change in bone marrow lesion (BML) volume between pre-treatment MRI and posttreatment MRI at day 53 – is an objective and indisputable measure and indicates if the drug is working to slow the progression of the disease. An increasing BML indicates progression (worsening) of the disease whilst a decreasing BML indicates regression (improvement) of the disease.

“The complete and final data set has not yet been received by the Company and there is nothing new to report. However, the Company will report on the Phase 2b secondary endpoints when the final data is ready for disclosure to the market.

READ: Paradigm Biopharmaceuticals to court partners and licensees for OA drug commercialisation

“Due to the comprehensive nature of this secondary endpoint data it is expected to be of significant interest to both the investment community and the pharmaceutical industry, hence the increasing attention the company is receiving in the lead up to the release of these results.

“In addition, we also note technical analysis supports strong positive trading momentum, potentially further adding to the current interest in the company.”

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Thu, 28 Mar 2019 10:42:00 +1100 https://www.proactiveinvestors.com.au/companies/news/217370/paradigm-biopharmaceuticals-gets-a-speeding-ticket-for-18-price-increase-217370.html
<![CDATA[News - Paradigm Biopharmaceuticals director shows confidence with on-market share purchase ]]> https://www.proactiveinvestors.com.au/companies/news/216057/paradigm-biopharmaceuticals-director-shows-confidence-with-on-market-share-purchase-216057.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) director Christopher Fullerton has purchased 100,000 shares on-market for a total consideration of $118,116.

The transaction brings Fullerton’s total holding (direct and indirect) to 836,000 shares.

READ: Paradigm Biopharmaceuticals moving towards phase 2/3 MPS clinical trial

The company has begun discussions with International key opinion leaders (KOL’s) for mucopolysaccharidoses (MPS) clinical trial design and site selection.

MPS is a progressive rare disease caused by the absence or malfunctioning of lysosomal enzymes and has a severe unmet need.

Paradigm is focused on repurposing the drug pentosan polysulfate sodium in its injectable form (iPPS), a US FDA approved drug that has a long track record of safely treating inflammation.

The company is confident that a single successful phase 2/3 clinical trial will enable iPPS to be registered as a treatment for certain MPS indications.

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Fri, 08 Mar 2019 15:29:00 +1100 https://www.proactiveinvestors.com.au/companies/news/216057/paradigm-biopharmaceuticals-director-shows-confidence-with-on-market-share-purchase-216057.html
<![CDATA[News - Paradigm Biopharmaceuticals moving towards phase 2/3 MPS clinical trial ]]> https://www.proactiveinvestors.com.au/companies/news/214598/paradigm-biopharmaceuticals-moving-towards-phase-23-mps-clinical-trial-214598.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has begun discussions with International key opinion leaders (KOL’s) for mucopolysaccharidoses (MPS) clinical trial design and site selection.

MPS is a progressive rare disease caused by the absence or malfunctioning of lysosomal enzymes and has a severe unmet need.

READ: Paradigm Biopharmaceutical shares surge on clinical trial success

Paradigm is focused on repurposing the drug pentosan polysulfate sodium in its injectable form (iPPS), a US Food and Drug Administration (FDA) approved drug that has a long track record of safely treating inflammation.

The company conducted a satellite meeting on February 3-4th at the “World Symposium 2019, 15th Annual Research Meeting on Lysosomal Disease Research” in Orlando, USA to discuss plans for its upcoming multinational phase 2/3 MPS clinical trial.

The clinical trial discussion panel included world-renowned KOLs in lysosomal storage disease and MPS from USA, UK, Germany and Japan, members of Paradigm’s clinical team and the manufacturer of PPS - bene pharmaChem.

 

Furthermore, Paradigm’s recently acquired MPS clinical data was further validated at the World Symposium by a paper presented by Dr Furujo that demonstrated iPPS has a positive impact on pain and physical function in patients with MPS types I, II and VI.

Upcoming phase 2/3 clinical trial

Paradigm is confident that a single successful phase 2/3 clinical trial will enable iPPS to be registered as a treatment for certain MPS indications.

MPS is classified as an orphan indication/designation in the US and EU and this should help accelerate the regulatory approval process and ultimately the time it takes for the treatment to enter the market as well as providing for a minimum 7 years (10 for EU) market exclusivity.

The panel concurred that the trial design will likely involve patients receiving ERT or BMT as standard of care and that PPS treatment be used as an adjunct therapy (i.e. therapy that is given in addition to the primary or initial therapy to maximize its effectiveness).

READ: Paradigm Biopharmaceuticals to court partners and licensees for OA drug commercialisation

Paradigm’s clinical and regulatory team in conjunction with the KOLs will be preparing a detailed study protocol and regulatory documents for the phase 2/3, which will be a multi-national, multi-centre trial likely incorporating centres in Australia, USA, UK and Germany.

It is anticipated these documents will be submitted to the regulatory agencies in Q2 CY2019

Commercial opportunity

The current standards of care are not adequate in treating pain associated with joint inflammation and musculoskeletal issues and these drugs currently equate to a market size of around US$1.4 billion per annum.

Big Pharma have a growing interest in orphan indications given the exclusivity from regulators and strong demand due to the critical unmet needs and attractive margins.

Paradigm will continue to actively engage with potential big pharma partners on this blockbuster indication.

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Thu, 14 Feb 2019 12:35:00 +1100 https://www.proactiveinvestors.com.au/companies/news/214598/paradigm-biopharmaceuticals-moving-towards-phase-23-mps-clinical-trial-214598.html
<![CDATA[News - Paradigm Biopharmaceuticals to court partners and licensees for OA drug commercialisation ]]> https://www.proactiveinvestors.com.au/companies/news/213114/paradigm-biopharmaceuticals-to-court-partners-and-licensees-for-oa-drug-commercialisation-213114.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) plans to take a partnering or licensing track to commercialise the repurposing of pentosan polysulfate sodium (PPS) for a painful arthritic bone condition after a clinically-meaningful successful Phase 2b clinical study.

The company last month released top-line data from its clinical trial in patients with OA-related knee pain and subchondral bone marrow edema lesions (BMELs), revealing the trial met its primary endpoint with a change in the knee injury and OA outcome score (KOOS).

Paradigm then highlighted that the trial had produced a clinically meaningful and statistically significant result of a pain reduction of 50% or more in patients, using their KOOS scores as a measure.

A notable 46.2% of subjects receiving the injectable PPS (iPPS) showed a greater than 50% reduction in pain from baseline compared to 22.5% of subjects receiving placebo, under the KOOS pain sub-scale.

READ: Paradigm Biopharmaceutical shares clinical trial success

The company highlighted respected opinion on what is considered clinical meaningfulness and statistical significance for pain as an end-point, quoting a Pain Outcomes report from 2010, cross-published to the US NIH NCBI repository, that stated “a 30% reduction of pain can be considered clinically significant.

“This level corresponds with a ‘much improved’ or ‘very much improved’ response from patients on a global impression of change, or 2 points on a 0 to 11 pain intensity numerical rating scale.”

Paradigm opted for a 50% reduction in pain for its endpoint in its study of patents with knee OA and BMELs.

 

Paradigm chief executive officer Paul Rennie said on December 20, 2018: “I would like to confirm the Paradigm Phase 2b clinical trial met its primary endpoint.

“In addition to that, Paradigm wanted to present top-line results and that Paradigm achieved a clinically meaningful and a statistically significant result between iPPS and placebo in the total population and highly clinically meaningful and highly statistically significant results in the NRS 4-6 strata.”

READ: Paradigm Biopharmaceuticals ‘next Australian blockbuster biotech’, according to Fiftyone Capital

Paradigm’s CEO flagged clinically meaningful and statistically significant results during phase 2 studies in humans bode well for the success of the final studies needed to take a drug to regulators for approval to use for a particular indication.

Rennie said: “If you have both a clinically meaningful and statistically significant result you have a high probability that the drug will be successful in a phase 3 clinical trial and once registered, a drug that can penetrate the market.”

Results of the study’s secondary endpoint data are still being evaluated, as is custom, however, two of the datasets have been analysed, the company reported on December 20, 2018.

These show that in comparison with placebo, statistical differences were achieved in NRS pain score (day 39 and 53), patient global impression of change (PGIC, p=0.0062), and proportions of patients with 25% and 50% reductions in time points other than day 53.

To help explain the importance of the data and of having a product that is both clinically meaningful and statistically significant, the company put together a video explanation presented by its principal investigator Professor Andrew Östör, orthopaedic surgeon Dr David Martin, sports physician Dr Phil Bloom and retired AFL footballer Andrew Walker.

Paradigm’s strategic approach

Paradigm’s strategic approach includes repurposing existing drugs with historically strong safety data and using the drugs for new purposes, like treating OA in humans.

The semi-synthetic polysulfated xylan PPS has a long history, being used as a blood thinner and interstitial cystitis or painful bladder syndrome treatment in humans.

The calcium salt of PPS was also one of the first reported disease-modifying OA drugs (DMOADs).

It is used to treat OA in dogs and horses.

READ: Paradigm Biopharmaceuticals’ positive trial results potentially transformational, says Morgans research

PPS was reported as a chondroprotective drug in 1988, with a detailed rationale of the molecule’s disease-modifying activity published the next year.

The mechanism of PPS in OA is put down to its multifactorial nature of stimulating cartilage matrix synthesis and preventing cartilage breakdown.

Paradigm’s drug repurposing of PPS uses the 505(b)(2) pathway.

A second strategy for Paradigm is to “develop therapeutics targeting multiple pathways”.

Paradigm hopes that by repurposing drugs it can reduce development costs.

It also hopes that by targeting multiple pathways involved in injury or on the road to disease, it can produce better outcomes for patients.

Paradigm’s forecasted timeline development compared to industry standards

1. Khanaoure A, Chuki P & De Sousa A (2014); 2. Ashurn T & Thor K (2004) PPS safety compared to approved OA drugs

Paradigm drew investors’ attention to the safety profile of PPS, compared to OA drugs on the market for use in humans.

The company reported on December 20, 2018: “Paradigm, would like the reiterate the real and significant commercial potential of iPPS as a safe, effective, durable, repeat (year-on-year) treatment for OA.

“Especially in the context of the nearest comparator treatments currently going through clinical development, the anti-NGF class of small molecules.”

The company compared the six-week dosing schedule of its iPPS to the monoclonal antibody against nerve growth factor as a treatment for pain, Tanezumab (INN, RN624).

Paradigm wrote: “Both iPPS and the anti-NGFs are administered via several sub-cutaneous injections — for example, Tanezumab is intended to be administered at 8-week intervals (seven doses total) for up to about 1 year and iPPS is administered twice-weekly for 6 weeks with SAS data indicating potential durability up to about 12 months.

“We do note 6-month duration of effect data via the phase 2b trial is yet to be collected and therefore cannot be reported on as yet, but the company is very encouraged by the duration of effect witnessed in the TGA SAS patients.”

The company said on December 18, 2018, it was confident the Therapeutic Goods Administration (TGA) special access scheme results, averaging 51.5% of greater pain reduction for knee pain in 125 patients, would be replicable in the US.

PPS pipeline

Paradigm has executed a 20-year exclusive supply agreement with bene PharmaChem GmbH & Co, the original developer and only FDA-approved manufacturer of PPS.

The agreement grants exclusive supply of only FDA-approved PPS for all orthopaedic including alphavirus respiratory and cardiovascular indications.

Under the agreement Paradigm will pay PharmaChem a single-digit royalty on commercial sales.

Paradigm has also patented its specific indications to a minimum of 2,030 indications, with established regulatory exclusivity and trademarks.

READ: Paradigm Biopharmaceuticals signs agreement for use of iPPS in treatment of MPS

Patent applications have been made for OA and concurrent BMEL, Ross River virus and Chikungunya virus.

iPPS is not currently registered in Australia but is registered in four of the seven major global pharmaceutical markets.

In European markets, iPPS is registered as an antithrombotic agent.

iPPS for human use is not available for sale in Australia and is only available by inclusion into a Paradigm-sponsored clinical trial or via a treating physician applying for its use in patients via the Therapeutic Goods Administration’s SAS category B.

Licensing and partnering potential

Paradigm believes in the attractiveness of iPPS for potential partners or licensees.

It reported: “In the true context of partnering/licensing attractiveness, the safety profile of iPPS versus the anti-NGFs cannot be underestimated.

“The anti-NGFs have all been put on clinical hold by the FDA at various stages due to serious adverse events (AEs) such as rapid joint disintegration or rapidly progressive OA.”

The company highlighted the size of the deals that big pharmaceutical companies had made with companies pursuing OA-drug commercialisation.

Paradigm wrote: “Despite these serious safety issues numerous big pharma transactions have occurred over recent years with one of the largest being Elly Lilly partnering with Pfizer on Tanezumab for US$200 million upfront and up to US$1.6 billion in milestones — that is (a) US$1.8 billion total potential transaction size.

“Paradigm, therefore feels very confident in the partnering/licensing potential of iPPS and ... remains committed to progressing this pathway as part of the commercialisation of its OA program.”

Capital matters

Paradigm has a market capitalisation of $147.85 million.

At the time the company announced its trial results in December 2018 it had $10.5 million cash and no debt.

Paradigm’s quarterly results for the December 2018 half-year are pending, however, the company used $2.2 million on its operating activities in the October 2018 quarter, $21,000 on investments and $1 million on financing activities.

It subsequently ended the quarter with $1.3 million cash and no debt.

READ: Paradigm Biopharmaceuticals boosts financial position with $2.32 million R&D tax rebate

Paradigm estimated on October 31, 2018, it would have $2.2 million in cash outflows during the December 2018 quarter.

The company then received a $2.32 million research and development tax incentive refund from the Australian Government in November 2018.

Paradigm's largest investor on December 13, 2018, was its managing director Rennie.

Technology vendor MJGD Nominees had a 4.9% stake while technology vendor Irwin Biotech held 4.5%, JP Morgan Nominees Aust Pty Ltd had 3% and Citicorp Nominees Pty Ltd held 2.3%.

Other board members and management besides Rennie had a collective 5.1% stake.

— with Berkay Erkan

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Tue, 22 Jan 2019 21:25:00 +1100 https://www.proactiveinvestors.com.au/companies/news/213114/paradigm-biopharmaceuticals-to-court-partners-and-licensees-for-oa-drug-commercialisation-213114.html
<![CDATA[News - Paradigm Biopharmaceutical shares surge on clinical trial success ]]> https://www.proactiveinvestors.com.au/companies/news/211356/paradigm-biopharmaceutical-shares-surge-on-clinical-trial-success-211356.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has met its primary endpoint of its phase IIb randomised double-blind placebo-controlled multi-centre clinical trial.

The primary outcome of the trial is to evaluate the effects of injectable pentosan polysulfate sodium (iPPS) on knee pain in subjects with knee OA and subchondral bone marrow edema lesions (BMELs).

This is assessed by the KOOS pain subscale using a numeric rating scale (NRS), a NRS 4-6 is moderate pain and an NRS 7-8 is high pain.

46.2% of subjects receiving iPPS showed a greater than 50% reduction in pain from baseline compared to 22.5% of subjects receiving placebo under KOOS pain subscale.

Investors responded positively, with Paradigm up as much as 63% to an intra-day high of $2.15, which is also a new 12-month high.

The biotech’s objective is to advance the clinical development plan for iPPS as an effective treatment for OA which will include filing a new drug application (NDA) with the USA Food and Drug Administration (FDA) for a phase III clinical trial next year.

  READ: Paradigm Biopharmaceuticals gets more real world evidence of treatment success

Paradigm’s CEO Paul Rennie said the Paradigm clinical and regulatory team, along with all the clinical trial recruitment and treatment centres, had done an extraordinary job concluding the trial in just over 12 months.

Results for phase II include only top line data and analysis of the secondary endpoints is ongoing.

However, initial comparisons with placebo, clinical and statistical differences were achieved in the NRS pain score (day 39 to 53), patient global impression of change (PGIC) and proportions of subjects with 50% reductions in timepoints other than day 53.

Full reporting on secondary endpoints will be provided in the first quarter of calendar year 2019, likely in conjunction with a peer-reviewed publication or presentation at a global orthopaedic conference.

The key outcome from the phase II trial was that clinically meaningful and statistically significant results between iPPS and placebo were demonstrated across the total subject population.

Clinically meaningful and highly statistically significant results were also demonstrated in the NRS pain levels 4-6 stratum.

1. Khanaoure A, Chuki P & De Sousa A (2014); 2. Ashurn T & Thor K (2004)

  “High probability the drug will pass a phase III clinical trial”

Rennie said: “To achieve clinically meaningful and statistically significant results between iPPS and placebo in the total population and highly clinically meaningful and highly statistically significant results in the NRS = 4-6 strata is truly an outstandingly positive trial outcome.

“If you have clinical significance and statistical significance you have a high probability the drug will pass a phase III clinical trial and once registered a drug that can penetrate the market.

“We are further impressed with the results given the widespread difficulty ASX-listed biotechnology companies have had in achieving positive phase IIb trial results over the last few years.”

READ: Paradigm Biopharmaceuticals gains on market with upcoming clinical trial read-out, wider treatment potential

Paradigm believes iPPS has the potential to receive fast-track designation from the FDA which is greatly concerned about the opioid epidemic.

The company notes a statement from the FDA commissioner Scott Gottlieb that one of the FDA’s goals is to “identify and encourage the development of new treatment options that don’t have the addictive features of opioids”.

Fast-track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Paradigm’s iPPS is neither an opioid nor a steroid, and most importantly is non-addictive, creating the potential to positively impact the opioid epidemic and treat OA pain.

  “Significant boost to partnering prospects”

Paradigm chairman Graeme Kaufman said: “The combined data from this trial support the high number of patients treated by their doctors via the TGA SAS.

“[The data] give us confidence that iPPS has the potential to be a safe, effective, long-lasting, non-opioid-based treatment for knee OA.

“Going forward we will be releasing additional SAS data on knee OA but also other joints which will broaden the applicability of the potential of iPPS as an OA pain reduction treatment.

“Today’s ground-breaking data also greatly strengthens the iPPS/OA licensing package and provides a significant boost to partnering prospects.”

READ: Paradigm Biopharmaceuticals ‘next Australian blockbuster biotech’, according to Fiftyone Capital

A recent report from Fiftyone Capital said Paradigm was shaping up to be the next major Australian biotech success story, predicting a less than 1% risk of failure for completed OA phase-2b clinical trial.

Provided Paradigm successfully signs licencing deals or commercialises all three of its current indications, the report anticipates a plus-$30 share price and market capitalisation around $5 billion.

The report notes the potential to identify other indications that have inflammatory issues as a symptom that could also be treated using iPPS.

Paradigm's share price over 13 months

  READ: Paradigm Biopharmaceuticals’ positive trial results potentially transformational, says Morgans research

Speaking at the company’s annual general meeting in August, Kaufman said there was a global trend for safe and effective non-opioid, non-steroid pain relief for chronic disease such as OA.

Kaufman said: “[This] presents a huge market opportunity for Paradigm’s iPPS.

“Like our OA program, [the Ross River virus program] is also a very exciting commercial opportunity.

“There are currently no registered therapeutics to treat the 10,000 cases of Ross River infections in Australia each year, nor the closely-related alpha virus Chikungunya.

"Chikungunya virus is endemic in many countries and there are millions of cases diagnosed each year again with no registered therapeutics to treat this debilitating disease.”

READ: Paradigm Biopharmaceuticals signs agreement for use of iPPS in treatment of MPS

Paradigm recently executed an agreement with a US-based medical school for use of its iPPS in the treatment of mucopolysaccharidoses (MPS).

The exclusive in-licence agreement covers the use of iPPS for MPS, a rare inherited disease which causes debilitating joint pain and dysfunction and a key unmet medical need in this class of inherited disease is the lack of treatment.

The company has also entered into a heads of agreement (HoA) regarding a strategic partnership with the New York-based Pro Players’ Elite Network (PPEN) to recruit and treat US-based sportspeople.

The partnership will be under a proposed FDA expanded access program commonly referred to as the ‘compassionate use’ program.

  READ: Paradigm Biopharmaceuticals boosts financial positions with $2.32 million R&D tax rebate

Paradigm views the partnership as an opportunity to not only treat people in need but to gain substantial exposure and promotion of the company and its treatment in the United States.

The US market is a key focus for Paradim given the significant number of OA sufferers – amounting to around 31 million – and in particular the large number of sportspeople and NFL players suffering from OA who are being prescribed opioids for chronic pain management.

Paradigm chief executive officer Paul Rennie said of HoA with PPEN: “Given the success Paradigm has had treating current and retired sportspeople, the company has been actively exploring ways to enter the US.

“Working with past elite sporting organisations such as PPEN allows us to gain access to a range of sportspeople in the US who would be ideal treatment candidates for iPPS.

“Paradigm will be able to work with and leverage the various sporting medical relationships that PPEN has in the US, which can potentially expedite our future US programs.”

The company said it was confident the Therapeutic Goods Administration (TGA) special access scheme results, averaging 51.5% or greater pain reduction for knee pain in 125 patients, will be replicable in the US.

READ: Paradigm Biopharmaceuticals chief executive Paul Rennie buys more shares

Paradigm has executed a 20-year exclusive supply agreement with bene PharmaChem GmbH & Co, the original developer and only FDA-approved manufacturer of PPS.

The agreement grants exclusive supply of only FDA-approved PPS for all orthopaedic including alphavirus respiratory and cardiovascular indications.

Under the agreement Paradigm will pay PharmaChem a single digit royalty on commercial sales.

Paradigm has also patented its specific indications to a minimum of 2030, with established regulatory exclusivity and trademarks.

Patent applications have been made for OA and concurrent BMEL, Ross River virus and Chikungunya virus.

iPPS is not currently registered in Australia but is registered in four of the seven major global pharmaceutical markets.

In European markets, iPPS is registered as an antithrombotic agent.

iPPS for human use is not available for sale in Australia and is only available by inclusion into a Paradigm-sponsored clinical trial or via a treating physician applying for its use in patients via the Therapeutic Goods Administration’s SAS category B.

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Tue, 18 Dec 2018 10:22:00 +1100 https://www.proactiveinvestors.com.au/companies/news/211356/paradigm-biopharmaceutical-shares-surge-on-clinical-trial-success-211356.html
<![CDATA[News - Paradigm Biopharmaceuticals to talk clinical trial results on conference call tomorrow morning ]]> https://www.proactiveinvestors.com.au/companies/news/211284/paradigm-biopharmaceuticals-to-talk-clinical-trial-results-on-conference-call-tomorrow-morning-211284.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) will host a conference call at 9.00am AEDT tomorrow morning to present and discuss the results of its phase IIb clinical trial.

The trial evaluated the effects of iPPS on the treatment of pain in subjects with knee OA and concurrent subchondral bone marrow edema lesions.

Investors can pre-register for this conference and avoid a queue when calling here.

READ: Paradigm Biopharmaceuticals has results pending for phase 2b clinical trial

The company entered a trading halt last Friday in anticipation of releasing the trial results.

Shares in the company last traded at $1.32 before being halted.

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Mon, 17 Dec 2018 15:27:00 +1100 https://www.proactiveinvestors.com.au/companies/news/211284/paradigm-biopharmaceuticals-to-talk-clinical-trial-results-on-conference-call-tomorrow-morning-211284.html
<![CDATA[News - Paradigm Biopharmaceuticals has results pending for phase 2b clinical trial ]]> https://www.proactiveinvestors.com.au/companies/news/211191/paradigm-biopharmaceuticals-has-results-pending-for-phase-2b-clinical-trial-211191.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) is in a trading halt with results pending for the company’s Phase 2b placebo-controlled OA/BMEL clinical trial.

The halt has been granted by the ASX and will remain in place until the start of normal trading on Tuesday, December 18, 2018, or when the announcement is released to the market, whichever occurs earliest.

Shares last traded at $1.32 after reaching a new 12-month high of $1.63 earlier this month.

READ: Paradigm Biopharmaceuticals gains on market with upcoming clinical trial read-out, wider treatment potential

Paradigm is focused on repurposing the drug pentosan polysulfate sodium in its injectable form (iPPS), a US Food and Drug Administration (FDA) approved drug that has a long track record of safely treating inflammation.

The company is working on several clinical indications for orthopaedic treatment of OA, BMEL, Ross River virus and Chikungunya and plans to establish commercial partnerships with pharmaceutical companies.

READ: Paradigm Biopharmaceuticals gets more real-world evidence of treatment success

Data was recently received from an additional 38 patients with knee OA that were treated with iPPS.

Combining these results with those previously reported for 145 patients brings the on average reduction in pain scores to 51.4% across the 183 patients.

The results continue to be superior to the typical 15% pain reduction scores reported for opioid treatments for chronic pain in OA of the knee and hip.

READ: Paradigm Biopharmaceuticals chief executive Paul Rennie buys more shares

Paradigm’s CEO Paul Rennie said: “We are very pleased to see that since October 2017 and after the report of the seventh group of Real World Evidence patients there is a consistent average knee pain reduction of greater than 50% in the 183 patients.

“Of important relevance is that Paradigm has accumulated data on 183 patients being successfully treated with iPPS for OA associated BMELs.

“The number of patients seeking treatment via the TGA SAS is a strong feedback that the patients are receiving a clinically meaningful benefit from the iPPS treatment.

“Given these patients have a very similar treatment regimen to subjects being treated under the phase II OA randomised, double-blind, placebo-controlled, clinical trial and these patients have failed current therapies to treat OA, we now look forward to the read-out of the multi-centre clinical trial.”

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Fri, 14 Dec 2018 11:28:00 +1100 https://www.proactiveinvestors.com.au/companies/news/211191/paradigm-biopharmaceuticals-has-results-pending-for-phase-2b-clinical-trial-211191.html
<![CDATA[News - Paradigm Biopharmaceuticals chief executive Paul Rennie buys more shares ]]> https://www.proactiveinvestors.com.au/companies/news/211113/paradigm-biopharmaceuticals-chief-executive-paul-rennie-buys-more-shares-211113.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) chief executive officer and managing director Paul Rennie has purchased 780,392 shares since November 15, 2017 for a total consideration of $545,000.

Rennie made the purchases through Paradigm’s share placements in 2017 and 2018 and via the company’s employee share plan.

Rennie’s latest purchase today (December 13, 2018) has increased his total holding (direct and indirect) in Paradigm to 23,379,935 shares.

READ: Paradigm Biopharmaceuticals gains on market with upcoming clinical trial read-out, wider treatment potential

Paradigm is focused on repurposing the drug pentosan polysulfate sodium in its injectable form (iPPS), a US FDA approved drug that has a long track record of safely treating inflammation.

The biotech company is working on several clinical indications for orthopaedic treatment of OA, BMEL, Ross River virus and Chikungunya and plans to establish commercial partnerships with multiple leading pharmaceutical companies.

A number of clinical trial results are due over the next year, including the phase-2b OA trial due by the end of December.

Paradigm’s drug repurposing strategy will deliver key benefits including lower costs; accelerated development timelines; and higher success rates than the standard clinical development timeline.

]]>
Thu, 13 Dec 2018 16:31:00 +1100 https://www.proactiveinvestors.com.au/companies/news/211113/paradigm-biopharmaceuticals-chief-executive-paul-rennie-buys-more-shares-211113.html
<![CDATA[News - Paradigm Biopharmaceuticals gets more real world evidence of treatment success ]]> https://www.proactiveinvestors.com.au/companies/news/210726/paradigm-biopharmaceuticals-gets-more-real-world-evidence-of-treatment-success-210726.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has received data from an additional 38 patients with knee OA that were treated with injectable pentosan polysulfate sodium (iPPS).

Combining today’s results of 38 patients with the previously reported 145 patients brings the on average reduction in pain scores to 51.4% across the 183 patients.

These results continue to be significantly superior to the typical 15% pain reduction scores reported for opioid treatments for chronic pain in OA of the knee and hip.

READ: Paradigm Biopharmaceuticals gains on market with upcoming clinical trial read-out, wider treatment potential

Paradigm’s CEO Paul Rennie said: “We are very pleased to see that since October 2017 and after the report of the seventh group of Real World Evidence patients there is a consistent average knee pain reduction of greater than 50% in the 183 patients.

“Of important relevance to us is that Paradigm now has accumulated data on 183 patients being successfully treated with iPPS for OA associated BMELs.

“The number of patients seeking treatment via the TGA SAS is a strong feedback that the patients are receiving a clinically meaningful benefit from the iPPS treatment.

“Given these patients have a very similar treatment regimen to subjects being treated under the current phase II OA randomised, double-blind, placebo-controlled, clinical trial and these patients have failed current therapies to treat OA, we now look forward to the read-out of the Phase 2b randomised double-blind placebo multicentre clinical trial on or before 21 December 2018.”

No serious adverse events supports safety of treatment

Paradigm is pleased to report that of the 183 patients that have been treated and reported on there have been no serious adverse events.

This provides further validation of the well-established safety profile of iPPS.

It supports the changes that a similar safety profile will be displayed in the current phase IIb trial underway.

Having a very safe pharmaceutical treatment is paramount in modern-day drug development.

]]>
Fri, 07 Dec 2018 10:56:00 +1100 https://www.proactiveinvestors.com.au/companies/news/210726/paradigm-biopharmaceuticals-gets-more-real-world-evidence-of-treatment-success-210726.html
<![CDATA[News - Paradigm Biopharmaceuticals gains on market with upcoming clinical trial read-out, wider treatment potential ]]> https://www.proactiveinvestors.com.au/companies/news/210374/paradigm-biopharmaceuticals-gains-on-market-with-upcoming-clinical-trial-read-out-wider-treatment-potential-210374.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) is an Australian company focused on repurposing the drug pentosan polysulfate sodium in its injectable form (iPPS), a US Food and Drug Administration (FDA) approved drug that has a long track record of safely treating inflammation.

The biotech company is working on several clinical indications for orthopaedic treatment of OA, BMEL, Ross River virus and Chikungunya and plans to establish commercial partnerships with multiple leading pharmaceutical companies.

A number of clinical trial results are due over the next year, including the phase-2b OA trial due by the end of December.

Paradigm’s drug repurposing strategy will deliver key benefits including lower costs; accelerated development timelines; and higher success rates than the standard clinical development timeline.

1. Khanaoure A, Chuki P & De Sousa A (2014); 2. Ashurn T & Thor K (2004)

 

Speaking at the company’s annual general meeting in August, Paradigm chairman Graeme Kaufman said there was a global trend for safe and effective non-opioid, non-steroid pain relief for chronic disease such as OA.

Kaufman said: “[This] presents a huge market opportunity for Paradigm’s iPPS.

“Like our OA program, [the Ross River virus program] is also a very exciting commercial opportunity.

“There are currently no registered therapeutics to treat the 10,000 cases of Ross River infections in Australia each year, nor the closely-related alpha virus Chikungunya.

"Chikungunya virus is endemic in many countries and there are millions of cases diagnosed each year again with no registered therapeutics to treat this debilitating disease.”

READ: Paradigm Biopharmaceuticals ‘next Australian blockbuster biotech’, according to Fiftyone Capital

A recent report from Fiftyone Capital said Paradigm was shaping up to be the next major Australian biotech success story, predicting a less than 1% risk of failure for the upcoming OA phase-2b clinical trial.

Provided Paradigm successfully signs licencing deals or commercialises all three of its current indications, the report anticipates a plus-$30 share price and market capitalisation around $5 billion.

It also expects results from the OA phase-2b trial to exceed data from Paradigm’s special access scheme (SAS) which has seen an average pain reduction of more than 50% in 145 patients.

  Other indications treatable with iPPS

The Fiftyone Capital report notes the potential to identify other indications that have inflammatory issues as a symptom that could also be treated using iPPS.

Paradigm recently executed an agreement with a US-based medical school for use of its iPPS in the treatment of mucopolysaccharidoses (MPS).

The exclusive in-licence agreement covers the use of iPPS for MPS, a rare inherited disease which causes debilitating joint pain and dysfunction and a key unmet medical need in this class of inherited disease is the lack of treatment.

The company has also entered into a heads of agreement (HoA) regarding a strategic partnership with the New York-based Pro Players’ Elite Network (PPEN) to recruit and treat US-based sportspeople.

The partnership will be under a proposed FDA expanded access program commonly referred to as the ‘compassionate use’ program.

READ: Paradigm Biopharmaceuticals signs agreement for use of iPPS in treatment of MPS

Paradigm views the partnership as an opportunity to not only treat people in need but to gain substantial exposure and promotion of the company and its treatment in the United States.

The US market is a key focus for Paradim given the significant number of OA sufferers – amounting to around 31 million – and in particular the large number of sportspeople and NFL players suffering from OA who are being prescribed opioids for chronic pain management.

Paradigm chief executive officer Paul Rennie said of HoA with PPEN: “Given the success Paradigm has had treating current and retired sportspeople, the company has been actively exploring ways to enter the US.

“Working with past elite sporting organisations such as PPEN allows us to gain access to a range of sportspeople in the US who would be ideal treatment candidates for iPPS.

“Paradigm will be able to work with and leverage the various sporting medical relationships that PPEN has in the US, which can potentially expedite our future US programs.”

The company said it was confident the Therapeutic Goods Administration (TGA) special access scheme results, averaging 51.5% or greater pain reduction for knee pain in 125 patients, will be replicable in the US.

  READ: Paradigm Biopharmaceuticals’ positive trial results potentially transformational, says Morgans research

A report from Morgans Financial Limited valued Paradigm in the range of 16 cents to $2.10 a share with a price target of 89 cents, noting an investment in the pharmaceutical company is appropriate for investors with a higher-risk profile.

The report said: “We believe the SAS cases act as a confidence barometer for trial success due in quarter four, calendar year 2018 (of which to date has been extremely successful).

“We view a positive trial result as transformative for the company and will trigger high levels of interest from large pharmaceutical companies, looking to partner through phase III trials and the regulatory pathway.

“Based on the successes of the SAS program to date and subsequent rally in the share price, we believe the market is already factoring in a high chance of success of the OA trial.

“We ultimately view trial success as the most likely scenario based on the strong SAS outcomes … although set our price target on a risk-weighted basis of 38% high case and 62% low case of which the high case representing the average rate of success in phase II trials.”

  READ: Paradigm Biopharmaceuticals boosts financial position with $2.32 million R&D tax rebate

Paradigm has executed a 20-year exclusive supply agreement with bene PharmaChem GmbH & Co, the original developer and only FDA-approved manufacturer of PPS.

The agreement grants exclusive supply of only FDA-approved PPS for all orthopaedic including alphavirus respiratory and cardiovascular indications.

Under the agreement Paradigm will pay PharmaChem a single digit royalty on commercial sales.

Paradigm has also patented its specific indications to a minimum of 2030, with established regulatory exclusivity and trademarks.

Patent applications have been made for OA and concurrent BMEL, Ross River virus and Chikungunya virus.

iPPS is not currently registered in Australia but is registered in four of the seven major global pharmaceutical markets.

In European markets, iPPS is registered as an antithrombotic agent.

iPPS for human use is not available for sale in Australia and is only available by inclusion into a Paradigm-sponsored clinical trial or via a treating physician applying for its use in patients via the Therapeutic Goods Administration’s SAS category B.

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Mon, 03 Dec 2018 03:35:00 +1100 https://www.proactiveinvestors.com.au/companies/news/210374/paradigm-biopharmaceuticals-gains-on-market-with-upcoming-clinical-trial-read-out-wider-treatment-potential-210374.html
<![CDATA[News - Paradigm Biopharmaceuticals ‘next Australian blockbuster biotech’, according to Fiftyone Capital ]]> https://www.proactiveinvestors.com.au/companies/news/210347/paradigm-biopharmaceuticals-next-australian-blockbuster-biotech-according-to-fiftyone-capital-210347.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) is shaping up to be the next major Australian biotech success story, according to a report from investment fund Fiftyone Capital.

Notably the report predicts a less than 1% risk of failure for Paradigm’s upcoming OA phase-2b clinical trial.

It also anticipates share prices of over $30 a share and a market capitalisation around $5 billion if Paradigm successfully signs licencing deals or commercialises all three of its indications.  

READ: Paradigm Biopharmaceuticals’ positive trial results potentially transformational, says Morgans research

The following is an extract from the report:

Testing the thesis

We feel that not many others have undertaken the same level of due diligence that we have done for Paradigm and therefore they do not understand what they own.

So when we hear comments like “the risk is that they fail the clinical trial”, we instantly recognise these investors probably haven’t adequately valued this business or weighted this risk with a probability.

Not only is Paradigm likely to see success in their upcoming clinical trial for OA but given the safety and quality of the data being released, investors should ask themselves the question – what other indications that have inflammatory issues as a symptom could also be treated using iPPS?

Should Paradigm see success in their upcoming phase-2b clinical trials (OA and Ross River) they could potentially develop a whole suite of drugs to treat any disease with associated inflammation.

Results

The data released under Paradigm’s special access scheme (SAS) has seen an average pain reduction of 51.2% in 145 patients.

We believe that the results of the upcoming trial will exceed those from the 145 patients treated under the SAS program.

The clinical trial has very specific eligibility criteria – it requires a different dosage regimen than those in the SAS program.

The current phase-2b clinical trial will only treat 55 patients with Zilosul, with the remaining 55 patients receiving a placebo.

To further demonstrate our confidence in a successful result, a previous study done by Peter Ghosh in 2005 to test if iPPS (the major ingredient within Zilosul) was effective in treating OA, showed a statistical significance and would have passed a clinical trial.

Not only was that trial significant, but the difference between the Ghosh trial and Paradigm’s trial (and SAS results) are that patients now receive double the dosage of iPPS.

As you would expect, the results being released from Paradigm are significantly better than from the Ghosh study.

Summary

Zilosul will become the standard first-line treatment for OA once commercialised.

As demonstrated, we consider the risk of failure in Paradigm’s phase-2b OA clinical trial as less than 1% when you compare the results already being seen via the SAS data.

Compare them against our prior trials with placebo control and against other nerve growth factor (NGF) drugs, its’s starting to look like Paradigm are going to have the best OA product in the foreseeable future.

When this trial is successful, we believe the negotiations from big pharma will result in a deal too good to refuse.

This deal size will likely need to exceed US$2 billion in order to be reflective of the anti-NGF deals done.

We see upside risk to the size of this deal given the competitive tension that is likely to result as big pharma understand that Zilosul should become the preferred treatment of OA around the world.

To put this into perspective, in terms of Paradigm’s share price, a US$2-billion deal on the current issued capital would result in an Australian Dollar-equivalent price of $19.80 a share.

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Sun, 02 Dec 2018 21:02:00 +1100 https://www.proactiveinvestors.com.au/companies/news/210347/paradigm-biopharmaceuticals-next-australian-blockbuster-biotech-according-to-fiftyone-capital-210347.html
<![CDATA[News - Paradigm Biopharmaceuticals’ positive trial results potentially transformational, says Morgans research ]]> https://www.proactiveinvestors.com.au/companies/news/210271/paradigm-biopharmaceuticals-positive-trial-results-potentially-transformational-says-morgans-research-210271.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has upside potential on successful trial results, according to a report from Morgans Financial Limited, despite receiving an initial “reduce” recommendation.

Morgans valued Paradigm in a range of 16 cents to $2.10 with a price target of 89 cents, noting an investment in the pharmaceutical company is appropriate for investors with a higher-risk profile.

Paradigm is an Australian company focused on repurposing the drug pentosan polysulfate sodium in its injectable form (iPPS) for orthopaedic treatment of OA and bone marrow edema lesions (BMEL).

The company has a number of clinical trial results due over the next year, including its phase-2b OA trial due by the end of this year.

Paradigm has been running pre-clinical studies for its OA/BMEL indication via the Therapeutic Goods Administration’s (TGA) special access scheme (SAS), receiving endorsements from several high-profile athletes who have been treated under the scheme.

READ: Paradigm Biopharmaceuticals signs agreement for use of iPPS in treatment of MPS

The following is an extract from the report:

Read-through for pivotal trial – major catalyst

PAR has been proactively running an unblinded treatment using ZOLUSUL via the TGA’s SAS, using a similar dosing regimen to its pivotal phase-2b trial counterpart.

To date, 145 patients with OA have been treated and reported on with an 86.8% response rate for a reduction in joint pain and improvement in knee function.

Pain level severity has been reduced by 51.2% on average across the group (compared to 15% pain reduction from opioid treatment for chronic pain in OA of the knee and hip – Seghal et al, 2013) and 91% improvement in knee function.

READ: Paradigm Biopharmaceuticals boosts financial position with $2.32 million R&D tax rebate

We believe the SAS cases act as a confidence barometer for trial success due in quarter four, calendar year 2018 (of which to date has been extremely successful).

We view a positive trial result as transformative for the company and will trigger high levels of interest from large pharmaceutical companies, looking to partner through phase III trials and the regulatory pathway.

Valuation range reflects binary nature

We have run a number of scenarios assuming different outcomes including: low (trial failure); current state (phase II pending); current state (phase II success); and a high case (un-risked) scenario.

The valuation range between scenarios reflects the binary nature of the asset and consequently the large risk-reward profile it represents.

Based on the successes of the SAS program to date and subsequent rally in the share price, we believe the market is already factoring in a high chance of success of the OA trial.

Investment view – taking profits ahead of binary event

We initiate coverage on PAR with a risked valuation range of 16 cents (phase II failure) to $2.10 (un-risked commercialised).

While it isn’t often investors get a significant read-through into the potential efficacy of a drug going through a double-blind trial, the rally over the last 12 months has increased potential risks to the downside if success is not achieved.

READ: Paradigm Biopharmaceuticals enters agreement to treat US-based sportspeople

We ultimately view trial success as the most likely scenario based on the strong SAS outcomes to date, although set our price target on a risk-weighted basis of 38% high case and 62% low case of which the high case representing the average rate of success in phase II trials.

Due to the risks associated with the regulatory clearance of pharmaceutical drugs, we initiate with a reduce recommendation and 89-cent target price.

We note the investment is appropriate for investors with a higher-risk profile.

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Fri, 30 Nov 2018 00:25:00 +1100 https://www.proactiveinvestors.com.au/companies/news/210271/paradigm-biopharmaceuticals-positive-trial-results-potentially-transformational-says-morgans-research-210271.html
<![CDATA[News - Paradigm Biopharmaceuticals signs agreement for use of iPPS in treatment of MPS ]]> https://www.proactiveinvestors.com.au/companies/news/209715/paradigm-biopharmaceuticals-signs-agreement-for-use-of-ipps-in-treatment-of-mps-209715.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has executed an agreement with a US-based medical school for use of its injectable Pentosan Polysulfate Sodium (iPPS) in the treatment of mucopolysaccharidoses (MPS).

The exclusive in-licence agreement has been signed with the Icahn School of Medicine at Mount Sinai, New York, and covers use of iPPS for MPS, a group of inherited lysosomal storage disorders.

MPS is a rare inherited disease which causes debilitating joint pain and dysfunction and a key unmet medical need in this class of inherited disease is the lack of treatment.

READ: Paradigm Biopharmaceuticals enters agreement to treat US-based sportspeople

The agreement includes Phase 2a safety and efficacy data which provides valuable long-term safety data on iPPS, which can be included in US FDA submissions for Paradigm’s OA/BMEL primary indication.

Synergies with OA/BMEL program

Paradigm said the licensing agreement and accompanying data was complementary and synergistic to the company’s OA/BMEL program.

As such, the company said it was a logical and valuable addition to the product pipeline and IP portfolio at this time.

READ: Paradigm Biopharmaceuticals boosts financial position with $2.32 million R&D tax rebate

The agreement was executed on attractive commercial terms, providing the company with highly valuable intellectual property (IP).

Based on Paradigm’s review of the human clinical data, the product development for the targeted population of people who have inherited the rare disease could receive ‘fast-track’ approval following a pivotal Phase 2b clinical trial.

The new IP will fall under the same terms of exclusivity and supply that Paradigm enjoys with bene pharmaChem.

READ: Paradigm Biopharmaceuticals secures $9 million to accelerate phase III

This newly in-licensed indication is fully funded for the next 12 months and beyond.

Paradigm’s primary focus remains reading-out of the Phase 2b OA/BMEL clinical trial head-line results, and this is expected in mid to late December 2018.

Leader in medical research

The Icahn School of Medicine at Mount Sinai is a not-for-profit corporation, which is a leader in medical and scientific training and education, biomedical research and patient care.

Mount Sinai Health System is New York City’s largest integrated health delivery system encompassing seven hospital campuses, leading medical school, and vast network of ambulatory practices throughout the greater New York region.

Paradigm is focused on repurposing Pentosan Polysulfate Sodium (PPS), an FDA approved drug that has a long track record of safely treating inflammation.

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Thu, 22 Nov 2018 11:07:00 +1100 https://www.proactiveinvestors.com.au/companies/news/209715/paradigm-biopharmaceuticals-signs-agreement-for-use-of-ipps-in-treatment-of-mps-209715.html
<![CDATA[News - Paradigm Biopharmaceuticals boosts financial position with $2.32 million R&D tax rebate ]]> https://www.proactiveinvestors.com.au/companies/news/209235/paradigm-biopharmaceuticals-boosts-financial-position-with-232-million-rd-tax-rebate-209235.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has strengthened its capital position after receiving a $2.32 million Research & Development (R&D) Tax Incentive Refund for the 2017/2018 financial year.

The company’s capital position now stands at $10.5 million, boosted by the R&D refund as well as completion of tranche II of the October $9 million capital raising.

This provides Paradigm with the funds to prepare regulatory filings with the US FDA and the Australian TGA following phase 2b read-out of results.

READ: Paradigm Biopharmaceuticals enters agreement to treat US-based sportspeople

CEO Paul Rennie said: “Receipt of this R&D rebate is well timed with the upcoming release of the primary endpoint for the 110-patient phase 2b OA randomised double-blind, placebo-controlled, multi-centre clinical trial.

“Data QC, analysis and preparation of documents for regulatory submissions in 2019 are underway for the phase 2b OA clinical trial.

“The clinical trial remains on its original timeline and within the financial budget with the readout of results in mid to late December 2018 to be a major value inflexion point for the company.”

Paradigm’s strong financial position will assist in funding preparations for US Compassionate Use/Expanded Access and US FDA IND submissions.

Rennie added: “Our strong financial position is significant as it allows us to continue to accelerate our OA programs and regulatory filings.

“We also intend to bring forward other value-add initiatives that we are working on and we look forward to updating the market on these activities in due course.”

READ: Paradigm Biopharmaceuticals secures $9 million to accelerate phase III

The Australian Government’s R&D Tax Incentive encourages companies to engage in R&D benefiting Australia, by providing a refundable tax offset of up to 43.5% for eligible R&D activities.

Focused on repurposing PPS

Paradigm is focused on repurposing pentosan polysulfate sodium (PPS), an FDA approved drug.

Injectable PPS is not currently registered in Australia but is registered in four of the seven major global pharmaceutical markets.

In European markets, injectable PPS is registered as an antithrombotic agent.

Injectable PPS for human use is not available for sale in Australia and is only available by inclusion into a Paradigm sponsored clinical trial or via a treating physician applying for its use in patients via the TGA’s SAS - Category B.

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Thu, 15 Nov 2018 11:25:00 +1100 https://www.proactiveinvestors.com.au/companies/news/209235/paradigm-biopharmaceuticals-boosts-financial-position-with-232-million-rd-tax-rebate-209235.html
<![CDATA[News - Paradigm Biopharmaceuticals secures $9 million to accelerate phase III ]]> https://www.proactiveinvestors.com.au/companies/news/207792/paradigm-biopharmaceuticals-secures-9-million-to-accelerate-phase-iii-207792.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has received commitments to raise $9 million in a share placement through the issue of 13.23 million shares priced at 68 cents.

Notably, the two-tranche placement will facilitate the addition of seven new institutional funds to the share register.

Funds raised in the placement will be used to accelerate the timeline to commencement of the phase III trial for its lead drug candidate pentosan polysulfate sodium (PPS) in 2019.

READ: Paradigm Biopharmaceuticals real world data confirms knee pain reduction

Paradigm’s managing director Paul Rennie said: “We are extremely pleased with the support received from new and existing investors, indicating strong confidence in Paradigm’s clinical program and upcoming catalysts.

“With pain reduction of more than 50% across 125 osteoarthritis patients the data from the TGA special access scheme continues to underpin the potential for our pentosan treatment.

“With two phase II clinical trials reading out before the end of 2018 it is an exciting and pivotal time for the company."

Funding phase III and US presence

Funds will be used to accelerate the timeline to the commencement of Paradigm’s anticipated phase III trial of its osteoarthritis treatment.

Additionally, funds will be used to establish a presence in the US and to fund a compassionate use program involving the US Pro Players Elite Network.

This includes over eleven thousand of the National Football League’s (NFL’s) past players.

Phase IIb read out on track for mid-December

Paradigm remains on track to announce the read out from its phase IIb 110 patient trial in mid-December 2018.

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Thu, 25 Oct 2018 10:18:00 +1100 https://www.proactiveinvestors.com.au/companies/news/207792/paradigm-biopharmaceuticals-secures-9-million-to-accelerate-phase-iii-207792.html
<![CDATA[News - Paradigm Biopharmaceuticals enters agreement to treat US-based sportspeople ]]> https://www.proactiveinvestors.com.au/companies/news/207807/paradigm-biopharmaceuticals-enters-agreement-to-treat-us-based-sportspeople-207807.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has entered into a heads of agreement regarding a strategic partnership with the New York-based Pro Players’ Elite Network (PPEN) to recruit and treat US-based sportspeople.

The partnership will be under a proposed Federal Drug Administration expanded access program, commonly referred to as the ‘compassionate use’ program.

It will aim to identify and assist elite sportspeople that have existing knee and joint pathologies that would benefit from treatment with Paradigm’s injectable pentosan polysulfate sodium (iPPS).

READ: Paradigm Biopharmaceuticals secures $9 million to accelerate phase III

Paradigm views the partnership as an opportunity to not only treat people in need but to gain substantial exposure and promotion of the company and its treatment in the United States.

The US market is a key focus for Paradim given the significant number of osteoarthritis (OA) sufferers – amounting to around 31 million – and in particular the large number of sportspeople and NFL players suffering from OA who are being prescribed opioids for chronic pain management.

READ: Paradigm Biopharmaceuticals real world data confirms knee pain reduction

Paradigm chief executive officer Paul Rennie said given the success Paradigm has had treating current and retired sportspeople in Australia, the company had been actively exploring ways to enter the US.

He said: “Working with past elite sporting organisations such as PPEN allows us to gain access to a range of sportspeople in the US who would be ideal treatment candidates for iPPS.

“Paradigm will be able to work with and leverage the various sporting medical relationships that PPEN has in the US, which can potentially expedite our future US programs.

“There is significant common ground between what Paradigm is trying to achieve by being the world’s first non-opioid, non-steroidal, non-addictive effective long-term treatment for chronic joint pain and PPEN’s desire to help combat the opioid problem amongst retired sportspeople and the community at large.”

The company said it was confident the Therapeutic Goods Administration (TGA) special access scheme results, averaging 51.5% or greater pain reduction for knee pain in 125 patients, will be replicable in the US.

  READ: Paradigm Biopharmaceuticals finalises Ross River virus trial recruitment

PPEN has a large network of over 11,000 retired athletes and trusted relationships among the ex-NFL player community, with extensive experience in driving high levels of participation in treatment trials.

Recently the organisation recruited over 150 retired players in a matter of months for a study involving the use of cannabidiol for chronic pain.

PPEN has relationships with the NFL Retired Players Association, the NFL Alumni Association Chapters across the US, Athletes for Care and After the Impact, a non-profit combating opiate addiction.

READ: Paradigm Biopharmaceuticals new data shows 60% pain reduction, shares rise

PPEN chief executive officer Mitch Marrow said: “PPEN will be able to utilise its established contacts and relationships with various NFL retired players and other elite sportspeople organisations, including the NFL Retired Players Association.

“It is well-documented that ex-elite sportspeople, especially football players, have higher rates of joint injuries than members of the general population and therefore are at a higher risk of developing chronic joint pain.

“The PPEN are concerned about the use of opioids to manage chronic joint pain and are passionate about helping people find new treatments for pain that are non-opioid and non-addictive and lead to better past-player welfare.

“The PPEN understands the success that Australian doctors have had, via the TGA Special Access Scheme, in treating Australian Rules Football players as well as people from the general public.”

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Thu, 25 Oct 2018 01:21:00 +1100 https://www.proactiveinvestors.com.au/companies/news/207807/paradigm-biopharmaceuticals-enters-agreement-to-treat-us-based-sportspeople-207807.html
<![CDATA[News - Paradigm Biopharmaceuticals enters trading halt ahead of capital raising ]]> https://www.proactiveinvestors.com.au/companies/news/207615/paradigm-biopharmaceuticals-enters-trading-halt-ahead-of-capital-raising-207615.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has been granted a trading halt by the ASX pending the release of details regarding a capital raising.

Shares in the company will remain halted until the earlier of either the release of the capital raising details or the commencement of trading on Thursday 25 October 2018.

READ: Paradigm Biopharmaceuticals real world data confirms knee pain reduction

Most recently Paradigm received data from an additional 25 patients with osteoarthritis (OA) that were being treated with injectable pentosan polysulfate sodium (iPPS).

This brought the total to 125 patients being treated with iPPS under the TGA’s special access scheme (SAS).

The average reduction in pain scores from the 125 patients was 51.5%.

Positively, this is significantly superior to the typical 15% pain reduction scores reported for opioid treatments for chronic pain in OA of the knee and hip.

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Tue, 23 Oct 2018 11:53:00 +1100 https://www.proactiveinvestors.com.au/companies/news/207615/paradigm-biopharmaceuticals-enters-trading-halt-ahead-of-capital-raising-207615.html
<![CDATA[News - Paradigm Biopharmaceuticals finalises Ross River virus trial recruitment ]]> https://www.proactiveinvestors.com.au/companies/news/203653/paradigm-biopharmaceuticals-finalises-ross-river-virus-trial-recruitment-203653.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has finalised the recruitment of its phase IIa clinical trial in participants with persistent Ross River virus (RRV) induced arthralgia (painful joints).

Subjects of the randomised, double-blinded placebo-controlled pilot clinical trial will be treated with injectable pentosan polysulfate sodium (iPPS).

Results from this phase IIa study are due to be reported by late in the December quarter of this year.

Paradigm’s CEO Paul Rennie said: “Strategically, this pilot study is aimed at providing the clinical evidence for the design of a larger clinical trial in Chikungunya Virus (CHIKV) induced arthralgia”.

READ: Paradigm Biopharmaceuticals new data shows 60% pain reduction, shares rise

CHIKV is closely related to the Ross River virus, both of the alphavirus genera.

Causing more than three million infections worldwide, CHIKV outbreaks have been reported in parts of Africa, Europe, Southeast Asia, and islands in the Indian and Pacific Oceans.

In 2013, CHIKV was found for the first time in the Americas and has spread to the Caribbean, South and Central America and North America.

No treatments present commercial opportunity

The expanding incidence and the lack of anti-viral agents, vaccines or effective pharmaceutical agents to treat CHIKV make iPPS a valuable product for this unmet medical need.

Similarly, there are currently no registered therapeutics to treat the ten thousand cases of Ross River infections in Australia each year.

Ross River recruitment capped at 20

Paradigm has decided to cap recruitment at 20 instead of 24 participants due to the significantly lower RRV incidence in 2018 compared to the 2017 outbreak.

Paradigm’s key objective of safety in the target population with RRV-induced arthralgia is expected to be met despite the shortfall of 4 participants.

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Tue, 28 Aug 2018 13:23:00 +1000 https://www.proactiveinvestors.com.au/companies/news/203653/paradigm-biopharmaceuticals-finalises-ross-river-virus-trial-recruitment-203653.html
<![CDATA[News - Paradigm Biopharmaceuticals new data shows 60% pain reduction, shares rise ]]> https://www.proactiveinvestors.com.au/companies/news/202902/paradigm-biopharmaceuticals-new-data-shows-60-pain-reduction-shares-rise-202902.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has achieved a 60.5% average reduction in pain from an additional 25 patients with osteoarthritis treated with injectable pentosan polysulfate sodium (iPPS).

The company believes these strong results can be attributed to this specific patient group undergoing a six week treatment period compared to a three or four week treatment period.

Paradigm has now received data from a total of 100 patients treated by their doctors under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS).

READ: Paradigm Biopharmaceuticals completes recruitment for knee pain trial

These patients were treated under a similar dosing regimen as Paradigm’s current 110-patient phase IIb osteoarthritis clinical trial, which recently completed recruitment.

Combining this latest result from 25 patients with the previously reported 75 patients increases the average reduction in pain scores to 52.9%.

These results are significantly superior to the typical 15% pain reduction scores reported for opioid treatments for chronic pain in osteoarthritis of the knee and hip.

More reports expected over coming months

Paradigm’s CEO Paul Rennie said: “We are very pleased to see the fourth group of Real World Evidence patients report results that have outperformed the previous three groups of patients we treated under the program.

“Of great importance to us is that Paradigm now has data on 100 patients being successfully treated with iPPS for OA associated BMELs.

“The number of patients seeking treatment via the TGA SAS is accelerating, which we believe is a strong indication that the patients are receiving a clinical benefit from the iPPS treatment.”

Paradigm will continue to report over the coming months on the groups of patients that are currently undergoing treatment from their doctors under the TGS SAS.

Results from the phase IIb clinical trial are expected to be released late in the December quarter of this year.

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Wed, 15 Aug 2018 10:31:00 +1000 https://www.proactiveinvestors.com.au/companies/news/202902/paradigm-biopharmaceuticals-new-data-shows-60-pain-reduction-shares-rise-202902.html
<![CDATA[News - Paradigm Biopharmaceuticals completes recruitment for knee pain trial ]]> https://www.proactiveinvestors.com.au/companies/news/202244/paradigm-biopharmaceuticals-completes-recruitment-for-knee-pain-trial-202244.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has recruited 100% of participants for its phase IIb clinical trial evaluating injectable pentosan polysulfate sodium (iPPS).

The randomised double-blind placebo-controlled trial aims to evaluate the effect of iPPS on knee pain in participants with knee osteoarthritis and subchondral bone marrow lesions.

The company expects to report the results of the pivotal phase IIb clinical trial by late in the December quarter 2018.

READ: Paradigm Biopharmaceuticals patients report over 50% pain reduction

Paradigm’s CEO Paul Rennie said: “The Paradigm clinical and regulatory team along with all the clinical trial recruitment and treatment centres have done an extraordinary job to conclude the recruitment of this phase II clinical trial in just over 7 months.

"What further underlines the outstanding job is the Paradigm’s second phase IIa clinical study (Ross River virus) is also nearing completion of recruitment.”

No adequate pain relief available

The iPPS has the potential to be a break-through in the treatment of osteoarthritis, where current therapies do not have adequate pain-relieving effects and are associated with adverse side effects.

Demand for an effective non-addictive alternative pain treatment has been amplified by the opioid epidemic in the US.

US FDA supporting new pain treatments

The US Food and Drug Administration (FDA) is taking steps to address the many facets of the complex opioid public health crisis.

Its goal is to support more rational prescribing practices, as well as identify and encourage development of new treatment options that don’t have the addictive features of opioids.

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Mon, 06 Aug 2018 10:52:00 +1000 https://www.proactiveinvestors.com.au/companies/news/202244/paradigm-biopharmaceuticals-completes-recruitment-for-knee-pain-trial-202244.html
<![CDATA[News - Paradigm Biopharmaceuticals’ leaping share price attracts ASX speeding ticket ]]> https://www.proactiveinvestors.com.au/companies/news/200320/paradigm-biopharmaceuticals-leaping-share-price-attracts-asx-speeding-ticket-200320.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has attracted a speed and volume ticket from the ASX following an increase in its share price from a low of 72.5 cents to an intraday high of 90 cents on Friday.

Responding to the price and volume query, the company said that there was no information that had not been announced to the market.

Paradigm believes that one of the possible reasons for the share price spike is due to recent positive results from knee osteoarthritis (OA) patients treated with its trial drug pentosan polysulfate sodium (PPS).

READ: Paradigm Biopharmaceuticals patients report over 50% pain reduction

Of the 75 patients, 84% responded with both a reduction in joint pain and an improvement in knee function.

Notably, patients’ self-reported pain scores were reduced over 50% on average from baseline pain scores.

Paradigm will continue to report over the coming months on the groups of patients that are currently undergoing treatment under the TGA Special Access Scheme (SAS).

READ: Paradigm Biopharmaceuticals osteoarthritis clinical trial ahead of schedule

Following the trial results revealed on 15 June 2018, Paradigm chief executive officer Paul Rennie said: “The number of patients seeking treatment via the TGA SAS is accelerating, which we believe is a strong indication that the patients are receiving a clinical benefit from the iPPS treatment.

“Given these patients have a very similar treatment regimen to subjects being treated under the current phase IIb osteoarthritis randomised, double-blind, placebo-controlled, clinical trial and these patients have failed current therapies to treat OA, we feel particularly confident regarding a positive clinical trial outcome, with the expected release of headline results for that trial due in Q4 CY 2018.”

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Mon, 09 Jul 2018 12:16:00 +1000 https://www.proactiveinvestors.com.au/companies/news/200320/paradigm-biopharmaceuticals-leaping-share-price-attracts-asx-speeding-ticket-200320.html
<![CDATA[News - Paradigm Biopharmaceuticals patients report over 50% pain reduction ]]> https://www.proactiveinvestors.com.au/companies/news/198908/paradigm-biopharmaceuticals-patients-report-over-50-pain-reduction-198908.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has received positive results from 75 patients with knee osteoarthritis (OA) being treated with its trial drug pentosan polysulfate sodium (PPS).

Of the 75 patients, 84% responded with both a reduction in joint pain and an improvement in knee function.

Notably, patients’ self-reported pain scores were reduced over 50% on average from baseline pain scores.

Superior to 15% pain reduction from opioid treatments

The maintained 50% average reduction in pain scores, observed with PPS in knee osteoarthritis, continues to demonstrate superiority over the opioid treatment alternative.

Historical data previously showed 15% pain reduction scores for opioid treatments for chronic pain in osteoarthritis of the knee and hip.

Real world data support ongoing clinical trials

These patients were treated under a similar dosing regimen as Paradigm’s current phase IIb osteoarthritis clinical trial, which is expected to release results in the coming December quarter.

READ: Paradigm Biopharmaceuticals osteoarthritis clinical trial ahead of schedule

The results from these 75 patients provide important real world evidence data, which can be used in combination with clinical trials to support product registration.

Paradigm will continue to report over the coming months on the groups of patients that are currently undergoing treatment from their doctors under the TGA Special Access Scheme (SAS).

Number of patients seeking treatment accelerating

Paradigm’s CEO Paul Rennie said: “The number of patients seeking treatment via the TGA SAS is accelerating, which we believe is a strong indication that the patients are receiving a clinical benefit from the iPPS treatment.

“Furthermore, it is a significant positive outcome that all these patients have on average, a clinically meaningful reduction in pain of 50%.

“Given these patients have a very similar treatment regimen to subjects being treated under the current phase IIb osteoarthritis randomised, double-blind, placebo-controlled, clinical trial and these patients have failed current therapies to treat OA, we feel particularly confident regarding a positive clinical trial outcome, with the expected release of headline results for that trial due in Q4 CY 2018.”

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Fri, 15 Jun 2018 10:21:00 +1000 https://www.proactiveinvestors.com.au/companies/news/198908/paradigm-biopharmaceuticals-patients-report-over-50-pain-reduction-198908.html
<![CDATA[News - Paradigm Biopharmaceuticals osteoarthritis clinical trial ahead of schedule ]]> https://www.proactiveinvestors.com.au/companies/news/197147/paradigm-biopharmaceuticals-osteoarthritis-clinical-trial-ahead-of-schedule-197147.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has recruited 80% of participants for its phase IIb clinical trial in knee osteoarthritis and bone marrow lesions.

This places the trial ahead of schedule with recruitment to be finalised over the coming month.

Importantly, this will allow for the pivotal results readout by the December quarter of 2018, a potential catalyst for the stock.

Shares were up almost 12% in early trade to 52.5 cents.

READ: Paradigm Biopharmaceuticals banking on near-term revenues from repurposing FDA approved drugs

The clinical trial will evaluate the effects of pentosan polysulfate sodium (PPS) on pain in participants with knee osteoarthritis and concurrent subchondral bone marrow lesions.

Injectable PPS has the potential to be a break-through in the treatment of osteoarthritis.

current therapies do not have adequate pain-relieving effects, provide no protection for the degenerating joint structures and are also associated with significant adverse side effects.

It is estimated that the size of the market is US$5 billion per annum.

TGA Special Access Scheme opens door to over 260 patients

260 osteoarthritis patients have now been treated by their doctors with PPS via the TGA Special Access Scheme.

This represents an almost doubling of the number of patients from six weeks ago showing real patient need for new osteoarthritis treatments.

Ross River clinical trial 75% recruited

Paradigm is also treating 24 patients with Ross River virus induced arthralgia (painful joints) as part of its phase IIa clinical trial of PPS injections.

The clinical trial is now over 75% recruited.

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Thu, 17 May 2018 10:52:00 +1000 https://www.proactiveinvestors.com.au/companies/news/197147/paradigm-biopharmaceuticals-osteoarthritis-clinical-trial-ahead-of-schedule-197147.html
<![CDATA[News - Paradigm Biopharmaceuticals banking on near-term revenues from repurposing FDA approved drugs ]]> https://www.proactiveinvestors.com.au/companies/news/196873/paradigm-biopharmaceuticals-banking-on-near-term-revenues-from-repurposing-fda-approved-drugs-196873.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) is a biotechnology company focused on repurposing Pentosan Polysulfate Sodium (PPS), an FDA-approved drug with a long track record of safely treating inflammation.

However, Paradigm is repurposing it for a number of applications with a focus on the treatment of orthopaedic and viral arthritic indications.

While the company’s market capitalisation of about $60 million could suggest it is a small player in a big pond, it has a blue-chip management team at the helm.

Heading the team is non-executive chairman Graham Kaufman, whose CV includes chief financial officer at CSL Limited (ASX:CSL) and executive vice-president of the $700 million Mesoblast Limited (ASX:MSB).

Strategy beginning to resonate with investors

The company’s strategy appears to be gaining traction with investors.

Of course, one of the advantages of drug repurposing is that it lowers costs and minimises risks, resulting in accelerated development times.

Paradigm’s share price has increased more than 60% in the last month and was up more than 12% on Friday when it hit a high of 52 cents, a level it hasn’t traded at since June 2017.

Establishment of commercial partnerships

Paradigm’s upfront costs aren’t as substantial as those encountered by companies developing and launching new drugs.

Such companies need to finance research and development, as well as conducting studies and trials, in most cases necessitating financing or royalty arrangements with larger players.

While Paradigm’s needs are different, it would be beneficial to establish commercial partnerships with pharmaceutical companies.

Success in achieving this goal may be a share price catalyst.

Multiple applications translate into large end market

PPS is a multi-acting treatment for osteoarthritis, viral arthritis, heart failure and respiratory conditions.

From an osteoarthritis perspective, it is useful in treating bone lesions and bruising.

Consequently, the treatment has broad applications across the ageing demographic, an increasingly emerging challenge for most first world countries.

As medical progress continues to enhance longevity, demand for treatments such as PPS should increase.

Paradigm’s management recently indicated that the combined addressable market was more than US$37 billion.

Vast difference in time to market

The following standard clinical development pipeline, as outlined by industry bodies, demonstrates significant difference between drug development and drug repurposing.

Research by Khanaoure A, Chuki P & De Sousa A in 2014 also demonstrated that the drug repurposing route had a 25% chance of successful commercialisation compared with 10% in ‘de-novo’ (starting from the beginning) drugs.

On the score of speed to market, Paradigm has demonstrated its efficiencies in this area, a factor that has no doubt resonated with investors.

In relation to its phase IIb osteoarthritis/bone marrow lesions development progress, the trial remains ahead of schedule with important results expected in the fourth quarter of 2018.

Management recently referred to this as one of the ‘value inflection points’ for the company, and it would appear logical that this will be reflected in its share price performance.

Success in Europe

Paradigm is also having success outside Australia.

In January, the company was granted a European patent for the treatment of bone marrow edema lesions with PPS.

Paradigm has initiated the process of validating the patent in most European countries, as well as the UK.

The company anticipates that the patent will be validated in these individual countries over the coming six months, providing an effective patent life of 20 years.

Management said that the patent would expire on February 2, 2032.

The European registration enhances Paradigm’s strong patent position, adding to previously granted registrations in the US, Japan, China, Canada, Taiwan, Singapore and Australia.

Additional layer of exclusivity

Paradigm has an additional level of market exclusivity via its supply agreement with bene pharmaChem GmbH.

Bene pharmaChem is the original manufacturer of PPS and its manufacturing process is protected via trade secrets.

The supply agreement with the group provides Paradigm with exclusive rights to the injectable PPS for use in humans for all its orthopaedic indications for a term of 20 years.

Paradigm also has the right to extend the term if it so chooses.

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Mon, 14 May 2018 14:12:00 +1000 https://www.proactiveinvestors.com.au/companies/news/196873/paradigm-biopharmaceuticals-banking-on-near-term-revenues-from-repurposing-fda-approved-drugs-196873.html
<![CDATA[News - Paradigm Biopharmaceuticals achieves pain treatment win with AFL players ]]> https://www.proactiveinvestors.com.au/companies/news/194287/paradigm-biopharmaceuticals-achieves-pain-treatment-win-with-afl-players-194287.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) is witnessing remarkable results in AFL players treated with injectable pentosan polysulfate sodium (PPS) for crippling knee, hip and groin pain.

Doctors (including AFL doctors) are treating current and ex-AFL players with PPS under the Therapeutics Goods Administration’s Special Access Scheme.

READ: Paradigm Biopharmaceuticals adds AFL legend to list of osteoarthritis treatment wins

PPS has been used for decades to treat blood clots and bladder syndrome in women but only recently emerged as a treatment option for osteoarthritis, a type of arthritis that results from the breakdown of joint cartilage.

Significantly reduced pain

Paradigm chief executive officer Paul Rennie revealed that six AFL players suffering from osteitis pubis (a common cause of chronic groin pain) were treated with PPS over the off-season.

Rennie said: “They all went from pain scores of six or seven out of 10 to zero.

“It was completely resolved. There’s no doubt it works and the AFL doctors who have used it love it.”

Rennie said that between 40 to 50 current AFL players at seven clubs are using the drug.

Real-world-evidence data to supplement phase II clinical trial

Under the Therapeutics Goods Administration’s (TGA) Special Access Scheme (SAS), doctors treat their patients with the same dosing regimen to the phase II clinical trials.

Currently there about 180 people being treated under the TGA SAS and these data will be important real-world-evidence data that can be used to supplement the phase II clinical data.

Doctors have reported data on the first 45 of 180 patients treated under the TGA SAS. Importantly, pain scores on those 45 patients were reduced on average by 50%.

AFL star added to list of PPS treatment wins

Retired Blues star Andrew Walker, whose AFL career was crippled by chronic knee pain, was one of the first players to trial PPS.

Rennie said: “He could hardly walk between practice sessions and had every available therapy thrown at him — but didn’t respond to any of it

“He is now running between 20 and 30 kilometres a week and has no knee pain and is playing (country) football again.”

READ: Paradigm Biopharmaceuticals’ osteoarthritis trial remains ahead of schedule

The company’s phase IIb clinical trial in participants with knee osteoarthritis and concurrent bone marrow lesions is 50% recruited and remains ahead of schedule.

The data from this clinical trial of PPS treatment is expected to be reported in the third quarter of calendar year 2018.

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Thu, 05 Apr 2018 11:25:00 +1000 https://www.proactiveinvestors.com.au/companies/news/194287/paradigm-biopharmaceuticals-achieves-pain-treatment-win-with-afl-players-194287.html
<![CDATA[News - Paradigm Biopharmaceuticals’ osteoarthritis trial remains ahead of schedule ]]> https://www.proactiveinvestors.com.au/companies/news/193829/paradigm-biopharmaceuticals-osteoarthritis-trial-remains-ahead-of-schedule-193829.html Paradigm Biopharmaceuticals Ltd’s (ASX:PAR) phase 2b clinical trial in participants with knee osteoarthritis and concurrent bone marrow lesions is 50% recruited and remains ahead of schedule.

The data from this clinical trial of Paradigm’s injectable pentosan polysulfate sodium (PPS) treatment is expected to be reported in the third quarter of calendar year 2018.

Paradigm chief executive officer Paul Rennie said: “the clinical trials are aimed at diseases for which there are very few safe and effective drugs meaning Paradigm is focusing on market sectors where there are high levels of unmet medical needs and high levels of commercial interest.

READ: Paradigm Biopharmaceuticals has success with PPS osteoarthritis treatment

Paradigm has been able to maintain a strong momentum in the clinical trial in participants with osteoarthritis (OA) and concurrent bone marrow lesions (BML).

Injectable PPS has the potential to be a ‘break-through’ treatment, whereas current therapies provide often inadequate pain-relief, have no effect on the degenerating joint structures or BMLs, and are also associated with significant adverse side effects.

Targeting the most common form of joint disease globally

It is estimated that the therapeutic treatment market size for OA is US$5 billion per annum and this figure could grow if new, effective, patented treatments such a PPS are commercialised.

OA also remains the most common form of joint disease globally. In the US alone, it affects over 27 million adults, while in Australia, arthritis affects around 3 million people.

Viral arthralgia phase 2a clinical trial progressing

Paradigm is also treating 24 patients with Ross River virus (RRV) induced arthralgia (painful joints) as part of its phase 2a clinical trial of PPS injections.

The phase 2a trial will demonstrate the potential of PPS as an effective treatment for patients with persistent joint symptoms following Ross River virus infection, where a treatment is desperately needed.

READ: Paradigm Biopharmaceuticals adds AFL legend to list of osteoarthritis treatment wins

Paradigm has provided PPS to doctors to treat a total of 147 OA patients via the TGA Special Access Scheme. Currently, 45 out of the 147 patients have completed PPS treatment for their OA.

Notably, the company recently added AFL legend Greg ‘Diesel’ Williams to its growing list of elite sportspeople benefiting from PPS.

Williams, who is in his early 50s, reduced osteoarthritis pain levels in his knees by circa 80% after he was treated by his doctor with PPS.

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Tue, 27 Mar 2018 11:21:00 +1100 https://www.proactiveinvestors.com.au/companies/news/193829/paradigm-biopharmaceuticals-osteoarthritis-trial-remains-ahead-of-schedule-193829.html
<![CDATA[News - Paradigm Biopharmaceuticals has success with PPS osteoarthritis treatment ]]> https://www.proactiveinvestors.com.au/companies/news/192384/paradigm-biopharmaceuticals-has-success-with-pps-osteoarthritis-treatment-192384.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has released promising information from trials of its injectable pentosan polysulfate sodium (PPS) treatment.

Of 45 patients treated, 84.4% responded with both a reduction in joint pain and an improvement in knee function.

Patients’ self-reported pain scores were reduced by 50% on average from baseline pain scores in 45 patients with knee osteoarthritis and concurrent bone marrow lesions.

In January, a European patent was granted for the treatment of bone marrow edema lesions with PPS.

READ: Paradigm Biopharmaceuticals granted European patent Results represent improvement on opioid treatments

The patients were treated by their doctor with injectable PPS under the Therapeutic Goods Administration’s Special Access Scheme (SAS).

The 50% reduction in pain scores observed with PPS in knee osteoarthritis is significant in relative terms.

It demonstrates superiority over the independently reported 15% pain reduction scores for opioid treatments for chronic pain in osteoarthritis of the knee and hip.

Fits criteria of clinically meaningful pain reduction

The comparative effects of PPS therapy against opioid treatments implies that the data provides evidence of clinically meaningful improvements in chronic pain.

Clinically meaningful reduction of chronic pain has been defined to be between 25-30% pain reduction by an independent source.

These results precede the read-out from Paradigm’s phase IIb randomised, double-blind, placebo-controlled, multicentre, clinical trial, which is expected in the fourth quarter.

By that stage the phase IIb clinical trial data will be supplemented with an additional 150 patients.

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Thu, 01 Mar 2018 09:28:00 +1100 https://www.proactiveinvestors.com.au/companies/news/192384/paradigm-biopharmaceuticals-has-success-with-pps-osteoarthritis-treatment-192384.html
<![CDATA[News - Paradigm Biopharmaceuticals adds AFL legend to list of osteoarthritis treatment wins ]]> https://www.proactiveinvestors.com.au/companies/news/190792/paradigm-biopharmaceuticals-adds-afl-legend-to-list-of-osteoarthritis-treatment-wins-190792.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has added AFL legend Greg ‘Diesel’ Williams to its growing list of elite sportspeople benefiting from pentosan polysulfate sodium (PPS) for osteoarthritis.

Williams, who is in his early 50s, reduced osteoarthritis pain levels in his knees by circa 80% after he was treated by his doctor with PPS.

As well as reducing pain, the PPS has reduced knee swelling, which helped reduce discomfort after exercise and dramatically improved knee function.

READ: Paradigm Biopharmaceuticals eyes opportunities to treat osteoarthritis

During his AFL career with Geelong, Sydney Swans and Carlton, the dual Brownlow medallist had several knee injuries and a number of arthroscopic procedures.

He developed osteoarthritis with concurrent bone marrow lesions and did not respond to the current standard of care treatments.

Treated with injectable PPS

His doctor then treated him with injectable PPS twice a week for four weeks.

Williams said: “Before treatment with PPS, my knee was so bad that the doctors were talking about a total knee replacement.

“The pain was so great that I couldn’t even drive properly, it hurt so much even to press down on the accelerator. 

“Now my pain levels have reduced by around 80% and I really don’t have any pain at all.

“My movement has also improved tremendously, I can bend properly and squat.

“I can also play tennis and golf regularly, something I couldn’t do before my treatment with the drug.”

Paradigm is repurposing PPS

Paradigm is focused on repurposing PPS, an FDA-approved drug that has a long track record of safely treating inflammation.

It is repurposing PPS for a number of applications with a focus on the treatment of orthopaedic and viral arthritic indications.

Treatment of past and present elite sportspeople is under the Therapeutic Goods Administration’s Special Access Scheme, demonstrating the unmet medical need in treating the condition.

Sportspeople at much higher risk

Over the past 12 months, circa 40 sportspeople have been successfully treated with an average reduction in pain scores of more than 50%.

Osteoarthritis affects as much as 13% of the world’s population with more than 75% of patients reporting the need for additional symptomatic treatment.

In the U.S. alone it affects in excess of 30 million people, which is expected to rise significantly with an ageing population.

Sports which involve running, pivoting, twisting and turning such as football, rugby, soccer and basketball put participants at a higher risk of developing osteoarthritis compared to the general population.

PPS is neither a steroid nor opioid, allowing for its approval in professional sports, and it is also non-addictive and free of debilitating side effects.

READ: Paradigm Biopharmaceuticals ahead of schedule with trials

In 2018, Paradigm’s arthritis program will be reporting on two phase II randomised double-blind placebo-controlled clinical trials investigating PPS in treating arthritis.

Paradigm will also be continually reporting on real world evidence of people with osteoarthritis being treated with PPS.

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Tue, 30 Jan 2018 12:19:00 +1100 https://www.proactiveinvestors.com.au/companies/news/190792/paradigm-biopharmaceuticals-adds-afl-legend-to-list-of-osteoarthritis-treatment-wins-190792.html
<![CDATA[News - Paradigm Biopharmaceuticals eyes opportunities to treat osteoarthritis ]]> https://www.proactiveinvestors.com.au/companies/news/190512/paradigm-biopharmaceuticals-eyes-opportunities-to-treat-osteoarthritis-190512.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) is witnessing a growing number of elite sportspeople being successfully treated by doctors with pentosan polysulfate sodium (PPS) for osteoarthritis.

Paradigm is focused on repurposing PPS, an FDA-approved drug that has a long track record of safely treating inflammation.

The treatment of the past and present elite sportspeople is under the Therapeutic Goods Administration’s (TGA) Special Access Scheme (SAS), demonstrating the unmet medical need in treating the condition.

The company is repurposing PPS for a number of applications with a focus on the treatment of orthopaedic and viral arthritic indications.

Sportspeople are at a much higher risk of developing osteoarthritis

Osteoarthritis (OA) affects in excess of 30 million people in the U.S. alone, which is expected to rise significantly with an ageing population, representing a blockbuster opportunity for Paradigm.

Sports which involve running, pivoting, twisting and turning such as football, rugby, soccer and basketball put participants at a higher risk of developing OA compared to the general population.

Therefore, sportspeople are at a much higher risk of developing OA, especially at earlier stages in life.

The drug is non-addictive and free of debilitating side effects

PPS is neither a steroid nor opioid, allowing for its approval in professional sports and more importantly, it is non-addictive and free of debilitating side effects.

OA affects as much as 13% of the world’s population with more than 75% of patients reporting the need for additional symptomatic treatment.

READ: Paradigm Biopharmaceuticals ahead of schedule with trials

In 2018, Paradigm’s arthritis program will be reporting on two phase II randomised double-blind placebo-controlled clinical trials investigating PPS in treating arthritis.

Paradigm will also be continually reporting on real world evidence of people with OA being treated with PPS.

READ: Paradigm Biopharmaceuticals granted European patent ]]>
Wed, 24 Jan 2018 15:49:00 +1100 https://www.proactiveinvestors.com.au/companies/news/190512/paradigm-biopharmaceuticals-eyes-opportunities-to-treat-osteoarthritis-190512.html
<![CDATA[News - Paradigm Biopharmaceuticals granted European patent ]]> https://www.proactiveinvestors.com.au/companies/news/190053/paradigm-biopharmaceuticals-granted-european-patent-190053.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has been granted a European patent for the treatment of bone marrow edema lesions with the drug pentosan polysulfate sodium (PPS).

The European registration solidifies global patent protection.

The granting of the European patent now means Paradigm has intellectual property rights in the major pharmaceutical markets of the U.S, Japan and Europe.

READ: Paradigm Biopharmaceuticals funded into 2019 through placement

During this calendar year, Paradigm will release the results of its two phase II arthritis clinical trials.

Granted patents in Europe, U.S. and Japan along with data from two phase II clinical trials provides a solid foundation for future plans including partnering discussions.

The benefits of drug repurposing

Paradigm is a biotechnology company focused on repurposing PPS, an FDA-approved drug that has a long track record of safely treating inflammation.

Paradigm is repurposing PPS for a number of applications with a focus on treatment of orthopaedic and viral arthritic indications.

Drug repurposing has the benefits of being lower cost, minimises risk and accelerated development timelines.

Paradigm’s strategy is to establish commercial partnerships with multiple leading pharmaceutical companies.

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Tue, 16 Jan 2018 10:04:00 +1100 https://www.proactiveinvestors.com.au/companies/news/190053/paradigm-biopharmaceuticals-granted-european-patent-190053.html
<![CDATA[News - Paradigm Biopharmaceuticals ahead of schedule with trials ]]> https://www.proactiveinvestors.com.au/companies/news/187680/paradigm-biopharmaceuticals-ahead-of-schedule-with-trials-187680.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) is ahead of schedule with two phase II clinical trials.

Once the studies are complete in 2018, commercially valuable data will be available.

Patients are being treated with the drug pentosane polysulfate sodium (PPS) and the trial is randomised, double-blind and placebo-controlled.

At 11.30am shares were up 3.3% to $0.31.

Paul Rennie, chief executive, said: “The trials are aimed at diseases for which there are very few safe and effective drugs.”

READ: Paradigm Biopharmaceuticals meets primary endpoint in clinical trial

The first study is evaluating the effects of PPS on pain in participants with knee osteoarthritis (OA) and concurrent subchondral bone marrow lesions.

It is almost 25% complete and well ahead of schedule.

PPS has potential to be a break-through osteoarthritis treatment

The company says injectable PPS has potential to be a break-through in the treatment of OA, which is the most common form of joint disease and a leading cause of pain and disability among the elderly.

“Current therapies do not have adequate pain-relieving effects, provide no protection for the degenerating joint structures and can also have significant adverse side effects,” Paradigm said.

The second study involves evaluating patients with Ross River virus (RRV) induced painful joints for safety, tolerability and effects on disease symptoms of PPS subcutaneous injections.

There are 24 people taking part in trials in Victoria and Queensland.

The company says recruitment is more than 60% complete and the study is well ahead of schedule with results on track for mid-2018.

An influx of participants is expected in coming months as mosquito numbers rise.

Ross River virus is on the rise

The incidence of Ross River virus is on the rise in Australia and Papua New Guinea and recent research has shown that it has the potential to become a global epidemic, similar to the Zika virus.

Results from Paradigm’s study are expected to provide important safety data and will be further evaluated to design subsequent larger trials.

The company hopes that the trials will demonstrate the potential of PPS as an effective treatment for patients with persistent symptoms following Ross River virus infection, where a treatment is desperately needed.

In 2017 Paradigm has completed one phase II clinical trial and started two additional phase II clinical trials in arthritis.

READ: Paradigm reveals outcomes from patient case studies on Osteoarthritis ]]>
Thu, 23 Nov 2017 09:32:00 +1100 https://www.proactiveinvestors.com.au/companies/news/187680/paradigm-biopharmaceuticals-ahead-of-schedule-with-trials-187680.html
<![CDATA[News - Paradigm Biopharmaceuticals meets primary endpoint in clinical trial ]]> https://www.proactiveinvestors.com.au/companies/news/187194/paradigm-biopharmaceuticals-meets-primary-endpoint-in-clinical-trial-187194.html Paradigm Biopharmaceuticals (ASX:PAR) has received results from its phase 2a clinical trial in bone marrow lesions (bone bruising) as a result of an anterior cruciate ligament (ACL) injury.

Importantly, the primary endpoint of safety and tolerability was met.

Paradigm was also successful in meeting its secondary endpoint, demonstrating a statistically significant reduction in bone marrow lesion (BML) volume as measured by MRI.

The top line results come from the analysis of safety data on 11 people who participated in the phase 2a open label trial to evaluate the drug, pentosan polysulfate (PPS).

The trial success confirms the company’s hypothesis that PPS could be a new treatment for acute joint injuries.

Secondary endpoint

Overall 6 of 9 (66.6%) participants showed reduction in BML and 8 of 9 (88.8%) had reduction in effusion-synovitis volume.

These results indicate that PPS has potential to significantly improve recovery from acute ACL injury, with significant improvement in both bone marrow lesion volumes and effusion volumes, function improvement and improved long-term outcomes for patients.

Paradigm’s patent to treat BMLs with PPS is already granted in the U.S, Japan and Australia.

The multi-billion dollar post-traumatic osteoarthritis (PTOA) market is very large with unmet medical needs.

Paul Rennie, CEO, commented

“The statistically significant reduction of both bone marrow lesion volume and effusion-synovitis volume is very encouraging data.

“Paradigm is delighted that the open labelled clinical trial (with blinded analysis of MRI’s before and after PPS treatment) successfully achieved its primary and secondary endpoints.

“We are also delighted to show for the first time both BML volume and effusion-synovitis volume was significantly reduced within a 2-month period postacute injury.

“We are hopeful the drug PPS could become standard of care, post-surgical reconstruction, with the potential to reduce the risk of a person developing PTOA”.

Other trials in process

In addition to the ACL clinical trial, Paradigm is also conducting two phase 2 clinical trials in degenerative osteoarthritis and viral induced arthritis.

The degenerative osteoarthritis is a phase 2b randomised, double-blind, placebo-controlled clinical trial with 100 patients.

The viral induced arthritis is a phase 2a randomised, double-blind, placebo-controlled clinical trial with 24 patients.

Paradigm expects to update the market on the recruitment status of these two trials in the coming weeks.

READ NOW: Paradigm Biopharmaceuticals funded into 2019 through placement ]]>
Tue, 14 Nov 2017 16:07:00 +1100 https://www.proactiveinvestors.com.au/companies/news/187194/paradigm-biopharmaceuticals-meets-primary-endpoint-in-clinical-trial-187194.html
<![CDATA[News - Paradigm Biopharmaceuticals funded into 2019 through placement ]]> https://www.proactiveinvestors.com.au/companies/news/186770/paradigm-biopharmaceuticals-funded-into-2019-through-placement-186770.html Paradigm Biopharmaceuticals (ASX:PAR) has completed a share placement to raise $5.75 million by issuing shares priced at $0.30 to institutional, sophisticated and professional investors.

The raising means Paradigm is well funded into CY2019 and importantly, post the completion of the Phase 2 Ross River virus and Phase 2b Osteoarthritis trials due to be completed at the end of CY2018.

In a vote of confidence, Paradigm’s management team participated in the capital raising with Paul Rennie electing to increase his holding by $100,000, subject to shareholder approval.

Paul Rennie, CEO, commented: “The strong support of institutional and sophisticated investors in this capital raising is a solid endorsement of our company and places Paradigm in a very strong position to accelerate our two Phase 2 clinical trials.

“Importantly, it means our company is well-funded post the completion of our key Phase 2 Ross River virus and osteoarthritis trials due to be completed by the end of CY2018.”

Use of funds

The proceeds from the placement will primarily be used to fund:

- The completion of the randomised, double-blind, placebo-controlled Phase 2b clinical trial in 100 subjects with osteoarthritis (OA) and concurrent bone marrow edema lesions (BMELs);
- Ongoing generation of real-world-evidence data in subjects with OA and concurrent BMELs;
- The expansion of the BMEL market into other joint and pain indications;
- The initiation of a pilot Phase 2 clinical trial in Chikungunya;
- Generation of intellectual property; and
- Working capital requirements.

Background

Paradigm is a biotechnology company focused on repurposing pentosan polysulfate sodium (PPS), an FDA-approved drug that has a long track record of safely treating inflammation.

Paradigm is repurposing PPS for a number of applications with a focus on treatment of orthopaedic and viral arthritic indications.

Drug repurposing has the benefits of being lower cost, minimises risk and accelerated development timelines.

Paradigm’s strategy is to establish commercial partnerships with multiple leading pharmaceutical companies.

OA with BMEL clinical trial

Paradigm recently dosed the first participant in the Phase 2b clinical trial investigating the use of PPS in people with knee OA and concurrent BMEL.

One hundred participants will be recruited across five trial sites in Queensland, South Australia, Victoria, and Western Australia with results anticipated in the March quarter of 2019.

READ NOW: Paradigm has successfully dosed first participant in clinical trial for osteoarthritis ]]>
Mon, 06 Nov 2017 15:09:00 +1100 https://www.proactiveinvestors.com.au/companies/news/186770/paradigm-biopharmaceuticals-funded-into-2019-through-placement-186770.html
<![CDATA[News - Paradigm Biopharmaceuticals to finalise raising ]]> https://www.proactiveinvestors.com.au/companies/news/186609/paradigm-biopharmaceuticals-to-finalise-raising-186609.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) remains focused on repurposing pentosan polysulfate sodium (PPS), an FDA-approved drug that has a long track record of safely treating inflammation.

Paradigm is repurposing PPS for a number of applications with a focus on treatment of orthopaedic and viral arthritic indications.

Drug repurposing comes at a lower cost, minimises risk and has accelerated development timelines.

The company is currently completing a capital raising, and the ASX has granted a trading halt to finalise.

The halt will remain in place until the opening of trade on Monday 6th November 2017, or earlier if an announcement is made to the market.

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Thu, 02 Nov 2017 09:26:00 +1100 https://www.proactiveinvestors.com.au/companies/news/186609/paradigm-biopharmaceuticals-to-finalise-raising-186609.html
<![CDATA[News - Paradigm has successfully dosed first participant in clinical trial for osteoarthritis ]]> https://www.proactiveinvestors.com.au/companies/news/186392/paradigm-has-successfully-dosed-first-participant-in-clinical-trial-for-osteoarthritis-186392.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has now dosed the first participant in the Phase 2b clinical trial at Emeritus Research in Malvern East, Victoria.

The research is undertaking a randomised, double-blind, placebo-controlled Phase 2b clinical trial investigating the drug pentosan polysulfate sodium (PPS) vs placebo in people with knee osteoarthritis and concurrent bone marrow lesions.

One hundred participants will be recruited across five trial sites in Queensland, South Australia, Victoria, and Western Australia with results anticipated in the March quarter of 2019.

The importance of the trials

Osteoarthritis is a condition with a significant unmet medical need.

An injectable PPS has the potential to be a break-through in treatment, as current therapies do not have adequate pain-relieving effects and provide no protection for the degenerating joint structures.

There are also significant adverse side effects.

A recent licensing deal highlights significant potential commercial opportunity for PPS, as French pharmaceutical group, Servier, licensed a Phase 1 OA drug candidate for US$346 million for rights to the European region.

Paul Rennie, chief executive officer, commented:

"We are very pleased to confirm the first participant has been treated in this important clinical trial.

"Injectable PPS could be a promising, safe and effective treatment for OA with concurrent BMLs – a condition with significant unmet medical need.

"Moreover, the Servier deal for GLPG1972, a Phase 1 drug that only inhibits ADAMTS-5, illustrates the potentially significant commercial value of PPS as PPS inhibits both cartilage destroying enzymes ADAMTS-4 and ADAMTS-5."

READ NOW: Paradigm reveals outcomes from patient case studies on Osteoarthritis ]]>
Mon, 30 Oct 2017 15:54:00 +1100 https://www.proactiveinvestors.com.au/companies/news/186392/paradigm-has-successfully-dosed-first-participant-in-clinical-trial-for-osteoarthritis-186392.html
<![CDATA[News - Paradigm reveals outcomes from patient case studies on Osteoarthritis ]]> https://www.proactiveinvestors.com.au/companies/news/185371/paradigm-reveals-outcomes-from-patient-case-studies-on-osteoarthritis-185371.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has outlined the results of 24 patient case studies with Osteoarthritis (OA) and Bone Marrow Edema Lesions (BMELs) that were treated with Pentosan Polysulfate Sodium (PPS) under the Therapeutic Goods Administration’s (TGA) Special Access Scheme.

PPS is a new multi-acting treatment.

In the 24 patients with a median age of 57.5 years (range 31 to 84 years), joint pain was reduced in 83% and knee function was improved in 80% of all cases treated.

These case studies are important to Paradigm as they provide Real World Evidence (RWE) data – i.e. the data from sources other than traditional clinical trials.

The United States Food and Drug Administration allows RWE data to be used in combination with Randomised Controlled Clinical Trials to support product registration for repurposed drugs such as PPS under the FDA 505(b)(2) regulatory pathway.

Next steps for Paradigm

In addition to the 24 case studies, Paradigm plans to generate an additional 75 case studies by Q4 CY2018.

These additional 75 case studies will be administered with increased doses compared to the first 24 cases.

This means by Q4 CY2018, Paradigm will have RWE data on 100 case studies in addition to the results of its Phase 2b randomised, double-blind, placebo-controlled clinical trial, which commenced in September 2017 and will enroll a total of 100 patients.

READ NOW: Paradigm Biopharmaceuticals receives ethics approval for trial on knee osteoarthritis

In the U.S. alone, the financial burden of OA has been estimated to be US$81 billion in medical costs and US$128 billion in total costs, given around 21 million people have OA associated limitations, while there are 36 million outpatient visits and 750,000 hospitalisations per year.

In Australia, arthritis affects around three million people or around 15% of the population.

OA is the leading cause of pain and disability among the elderly in Australia and the third-leading cause of life-years lost due to disability.

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Wed, 11 Oct 2017 11:02:00 +1100 https://www.proactiveinvestors.com.au/companies/news/185371/paradigm-reveals-outcomes-from-patient-case-studies-on-osteoarthritis-185371.html
<![CDATA[News - Paradigm Biopharmaceuticals receives ethics approval for trial on knee osteoarthritis ]]> https://www.proactiveinvestors.com.au/companies/news/184250/paradigm-biopharmaceuticals-receives-ethics-approval-for-trial-on-knee-osteoarthritis-184250.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has received ethics approval for its Phase 2b clinical trial to investigate Pentosan Polysulfate Sodium (PPS) in subjects with knee osteoarthritis (OA) and bone marrow edema lesions (BMELs).

Paradigm will investigate if the injectable PPS could be a safe and effective treatment for OA.

Currently, treatments do not have adequate pain-relieving effects, and provide no protection for the degenerating joint structures.

They are also associated with significant adverse side effects.

Paul Rennie, chief executive officer, commented:

"This is an important clinical trial as injectable PPS could be a promising, safe and effective treatment for BMELs in people with knee OA – a condition with significant unmet medical need.

"Most current treatments do not effectively address the disease and can have destructive effects on joint structure or adverse side effects."

The major goals are targeting a reduction in OA pain, and to stop or slow the structural destruction of the joint.

READ NOW: Paradigm shares continue uptrend on leverage to Pentosan Polysulfate Sodium

Rennie added: "Additionally, we hope PPS may offer an alternative to the use of opioids for treating OA pain.

"We look forward to commencing recruitment for the trial over the coming weeks."

Trial details

The trial will recruit 100 patients across four sites in Queensland, South Australia, Victoria and Western Australia.

The trial subjects will be evaluated for safety, tolerability, pain levels and effects on disease symptoms.

Results are anticipated in early 2019.

Market opportunity

The OA market represents a significant opportunity for Paradigm.

It is a condition with a large and, as yet, unmet medical need as most current treatments prescribed for the condition do not have adequate pain-relieving effects, provide no protection for the degenerating joint structures and are also associated with significant adverse side effects.

It is estimated that the size of the market is US$5 billion per annum and this figure could potentially be multiples higher if new, effective, patented treatments such a PPS are commercialised.

OA also remains the most common form of joint disease globally.

In the US alone, it affects more than 27 million adults, while in Australia, arthritis affects around three million people.

In both countries, the condition is a leading cause of pain and disability among the elderly and a cause of life-years lost due to disability.

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Wed, 20 Sep 2017 09:32:00 +1000 https://www.proactiveinvestors.com.au/companies/news/184250/paradigm-biopharmaceuticals-receives-ethics-approval-for-trial-on-knee-osteoarthritis-184250.html
<![CDATA[News - Paradigm's Paul Rennie discusses momentum of the Ross River Virus Clinical Trial ]]> https://www.proactiveinvestors.com.au/companies/news/183949/paradigm-s-paul-rennie-discusses-momentum-of-the-ross-river-virus-clinical-trial-183949.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) continues to advance its Phase 2 Ross River Virus Clinical Trial, with 25% of the 24-participant total having now been dosed across the initial two trial sites in Geelong and Brisbane.

This follows the commencement of the trial in August 2017.

A third trial site has been initiated in Echuca, and a fourth on the Gold Coast.

Trial participants will be evaluated for safety, tolerability and effects on disease symptoms, with results anticipated in Q2 CY2018.

Paul Rennie, chief executive officer, commented:

"We are very pleased to have such strong momentum in this trial so far, with a quarter of the 24-participant total now dosed following the trial’s commencement just last month.

"This strong start in recruiting eligible patients follows the outbreak of RRv seen earlier in 2017.

"Given RRv outbreaks are seasonal, we need to add more sites to keep our recruitment rates as high as possible.

"We look forward to initiating our fourth trial site in the Gold Coast over the coming weeks and recruiting more participants over the coming months.

"Ross River virus is a disease with a significant unmet medical need and we hope that PPS can prove to be an effective treatment.

"Current therapeutics can help to manage the joint pain associated with the virus but they have not been shown to treat the detrimental effects on joint cartilage that are associated with the disease.

"Current treatment options are also often inadequate in providing symptom relief, or associated with significant gastrointestinal side effects in patients with symptoms of joint pain which persist beyond the acute phase."

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Thu, 14 Sep 2017 13:23:00 +1000 https://www.proactiveinvestors.com.au/companies/news/183949/paradigm-s-paul-rennie-discusses-momentum-of-the-ross-river-virus-clinical-trial-183949.html
<![CDATA[News - Paradigm Biopharmaceuticals shares continue uptrend on leverage to Pentosan Polysulfate Sodium ]]> https://www.proactiveinvestors.com.au/companies/news/183786/paradigm-biopharmaceuticals-shares-continue-uptrend-on-leverage-to-pentosan-polysulfate-sodium-183786.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has added another 2% to $0.40 in early trade, after jumping 40% yesterday, following a peer-reviewed publication.

The publication was of a patient case study which confirms the significant potential of Pentosan Polysulfate Sodium (PPS) to treat subchondral Bone Marrow Edema Lesions (BMELs) in people with osteoarthritis (OA).

Paul Rennie, chief executive officer, commented:

"Targeting the entire degenerative joint, including the cartilage breakdown and the bone marrow edema lesions in the underlying bone of the joint, represents a Paradigm shift in treating painful OA.

"This case study underlines that PPS could be a promising, safe and effective treatment for BMELs in people with OA – a condition with significant unmet medical need."

The importance of this publication and the positive market reaction, is due to Paradigm commencing its Phase 2b trial of PPS for OA.

Rennie added: "Most current OA treatments do not effectively address the disease and can have destructive effects on joint structure or adverse side effects.

"We hope PPS can provide the two major goals of physicians and their OA patients alike - i.e. significantly reduce OA pain and stop or slow the structural destruction of the joint.

"Additionally, we hope PPS may offer an alternative to the use of opioids for treating OA pain."

The size of the market

In the U.S. alone, the financial burden of OA has been estimated to be US$81 billion in medical costs and US$128 billion in total costs, given around 21 million people have OA associated limitations, while there are 36 million outpatient visits and 750,000 hospitalisations per year.

In Australia, arthritis affects around three million people or around 15% of the population.

OA is the leading cause of pain and disability among the elderly in Australia and the third-leading cause of life-years lost due to disability.

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Tue, 12 Sep 2017 09:45:00 +1000 https://www.proactiveinvestors.com.au/companies/news/183786/paradigm-biopharmaceuticals-shares-continue-uptrend-on-leverage-to-pentosan-polysulfate-sodium-183786.html
<![CDATA[Media files - Paradigm's drug developments sees growing market opportunities ]]> https://www.proactiveinvestors.com.au/companies/stocktube/7931/paradigm-s-drug-developments-sees-growing-market-opportunities-7931.html Fri, 18 Aug 2017 08:30:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/7931/paradigm-s-drug-developments-sees-growing-market-opportunities-7931.html <![CDATA[News - Paradigm Biopharmaceuticals doses first Ross River participant ]]> https://www.proactiveinvestors.com.au/companies/news/182159/paradigm-biopharmaceuticals-doses-first-ross-river-participant-182159.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) has successfully dosed its first participant in its Phase 2 Alphavirus clinical trial of the drug pentosan polysulfate sodium (PPS) for the treatment of Ross River virus.

The commencement of the trial signifies strong momentum and depth in Paradigm’s clinical trial pipeline, making it the company’s fourth active clinical trial since listing on the ASX.

Trial subjects will be evaluated for safety, tolerability and effects on disease symptoms, with results anticipated in the June quarter of 2018.

READ: Paradigm Biopharmaceuticals CEO lifts stake over 22%

Paul Rennie, CEO, commented: “New treatments for the condition are desperately needed, especially in Victoria, where the rates of the disease have increased significantly, representing a large unmet medical need.

“Whilst current therapeutics can help to manage the joint pain associated with the virus, they have not been shown to treat the detrimental effects on joint cartilage that are associated with the disease.”

Phase 2 Alphavirus clinical trial

The first participant was treated at the Barwon Health site in Geelong and is the first participant to be enrolled in the trial which is being conducted across two sites in Victoria and Queensland.

The randomised, double-blinded placebo-controlled clinical trial will treat a total of 24 subjects across both the Victorian and Queensland sites.

Patients with Ross River induced arthralgia (painful joints) will be evaluated for safety, tolerability and effects on disease symptoms of PPS subcutaneous injections.

Results are anticipated in mid-2018.

Paradigm and Griffith University received a non-dilutive grant of A$300,000 from the Queensland Government during the quarter to accelerate the development of PPS to treat Ross River virus.

Victorian weather causes spike in Ross River

The incidence of Ross River virus in Victoria has spiked so far this year, with high amounts of rainfall and warm weather resulting in an unusually high number of infections.

A total of 1,911 cases have been identified in the half year ending June 30 this year, an 86.2% increase on 2016’s total of 263 cases.

PPS could also treat a second virus

PPS was also tested in the preclinical model of the Chikungunya virus and proven to be successful in treating the disease.

The Chikungunya virus is more widespread compared to RRV and the Pan American Health Organisation and the World Health Organisation reported for the first six months of CY2017 over 1 mln cases of the virus in the Americas alone.

Paradigm continues its discussions with the U.S. Department of Defense regarding the development of PPS for a treatment for Chikungunya virus infections.

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Wed, 09 Aug 2017 11:03:00 +1000 https://www.proactiveinvestors.com.au/companies/news/182159/paradigm-biopharmaceuticals-doses-first-ross-river-participant-182159.html
<![CDATA[News - Paradigm Biopharmaceuticals Ltd to commence Ross River trial ]]> https://www.proactiveinvestors.com.au/companies/news/180558/paradigm-biopharmaceuticals-ltd-to-commence-ross-river-trial-180558.html Paradigm Biopharmaceuticals Ltd (ASX:PAR) is now ready to commence its Phase 2 Alphavirus clinical trial of the drug pentosan polysulfate sodium (PPS) for the treatment of Ross River virus.

Ethics approval and site initiation of the two sites at Mater Research in Brisbane, Queensland and Barwon Health in Geelong, Victoria, means the company can commence participant recruitment.

The trial will recruit 24 participants with Ross River virus (RRV) in Queensland and Victoria - the dosing of the first participant is expected in the coming weeks.

Trial subjects will be evaluated for safety, tolerability and effects on disease symptoms, with results anticipated in the June quarter of 2018.

Paul Rennie, CEO, commented: “We look forward to recruiting participants and to commence dosing over the coming weeks.

“We hope that PPS can prove effective through this Phase 2 trial, especially as there are no effective pharmaceutical treatments available to RRV sufferers, making this a true unmet medical need.”


Clinical trial details

The randomised, double-blinded placebo-controlled clinical trial will treat a total of 24 subjects across both trial sites.

People with RRV-induced arthralgia (painful joints) will be evaluated for safety, tolerability and effects on disease symptoms of PPS subcutaneous injections, with results anticipated in mid-2018.

Other sites in Queensland are also being evaluated for this clinical trial.


Other trial updates

The Phase 2a Open Label Bone Marrow Edema Lesion trial is due to read-out at the end of the current September quarter.

Furthermore, the Phase 1 and Phase 2 Hay Fever clinical trials are complete and Paradigm is waiting on analysis of data.


Analysis

The Ross River clinical trial is Paradigm’s fourth clinical trial that has commenced in less than two years demonstrating its operational discipline to execute on its clinical development plans.

The Ross River virus affects hundreds of thousands of people in South Asia each year and there is currently no effective treatment for either disease.

Furthermore, the pre-clinical trial work has been peer-reviewed and published in the Journal of Virology.
PPS was also tested in the preclinical model of the Chikungunya virus and proven to be successful in treating the disease.

The Chikungunya virus is more widespread compared to RRV and the Pan American Health Organisation and the World Health Organisation reported for the first six months of CY2017 over 1 million cases of the virus in the Americas alone.

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Mon, 10 Jul 2017 09:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/180558/paradigm-biopharmaceuticals-ltd-to-commence-ross-river-trial-180558.html
<![CDATA[News - Paradigm Biopharmaceuticals CEO lifts stake over 22% ]]> https://www.proactiveinvestors.com.au/companies/news/179934/paradigm-biopharmaceuticals-ceo-lifts-stake-over-22-179934.html Paradigm Biopharmaceuticals (ASX:PAR) chief executive officer, Paul Rennie, is a major shareholder in the company and on-market purchases have lifted him to a 22.06% stake.

Earlier in the week Rennie spent just over $100,000 acquiring more shares.

The next steps for Paradigm will be to focus on completing the Phase 2 Bone Marrow Edema clinical trial and commencing the Ross River clinical trial.

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Wed, 28 Jun 2017 11:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/179934/paradigm-biopharmaceuticals-ceo-lifts-stake-over-22-179934.html
<![CDATA[News - Paradigm Biopharmaceuticals CEO buys shares on-market ]]> https://www.proactiveinvestors.com.au/companies/news/179783/paradigm-biopharmaceuticals-ceo-buys-shares-on-market-179783.html Paradigm Biopharmaceuticals (ASX:PAR) has received a vote of confidence from its CEO and director, Paul Rennie, who has purchased $100,618.95 worth of shares on-market.

The 285,000 shares purchased by entities related to Rennie increased his total number of direct and indirect shares held to 22.1 million.

The next steps for Paradigm will be to focus on completing the Phase 2 Bone Marrow Edema clinical trial and commencing the Ross River clinical trial.

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Mon, 26 Jun 2017 14:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/179783/paradigm-biopharmaceuticals-ceo-buys-shares-on-market-179783.html