Paradigm Biopharmaceuticals receives positive results for Ross River clinical trial
The trial was treating patients with joint pain or joint stiffness.
Company
ASX:PAR
Paradigm Biopharmaceuticals Ltd (ASX:PAR) is a drug repurposing company driven by core competencies and experience at board and executive level in clinical and commercial pharmaceutical development. The company’s approach is to take an existing approved drug, which has demonstrated safety in its approved indications, and repurposing the drug in a new patented therapeutic application. Paradigm’s pipeline indications cover the use of pharmaceutical compound Pentosan Polysulfate Sodium (PPS), supported by full patent and IP protection and its immediate commercial focus is the repurposing of PPS for the treatment of Osteoarthritis (OA).
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The trial was treating patients with joint pain or joint stiffness.
Doctors can administer the treatment to patients under the TGA Special Access Scheme.
Investments and investor services
Monday is Memorial Day in the US meaning stock markets are closed.
The retail entitlement offer had a take-up rate of about 54.7% for acceptances of entitlements and applications for additional shares by eligible retail shareholders.
Along with the entitlement offer, Paradigm has raised $51.6 million via a placement to professional, institutional and sophisticated investors.
The company has today commenced the retail component of its $77.9 million capital raising.
The capital raising has attracted a number of international institutional investors.
OA remains the most common form of joint disease globally, affecting over 30 million adults in the US alone.
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.
Over the past year, shares have come from 29 cents to be trading at around $1.90.
The company has begun discussions with International key opinion leaders for mucopolysaccharidoses (MPS) clinical trial design and site selection.
Investments and investor services
The rebalance changes are effective at the open of trading on March 18, 2019.
MPS or mucopolysaccharidoses is an orphan indication with market exclusivity and high profit margins.
The injectable PPS trial has had a clinically meaningful and statistically significant result in patients with arthritic knee pain.
The trial met the primary endpoint with a change in the knee injury and OA outcome score, confirming the potential for safe and effective treatment with iPPS.
The call will discuss the phase IIb randomised double-blind placebo controlled multicentre study.
A trading halt will remain in place until the start of trading on Tuesday, December 18, or when an announcement is released.
Paradigm is focused on repurposing the drug pentosan polysulfate sodium in its injectable form
Patients access the treatment through their doctor under the TGA’s Special Access Scheme.
The readout of clinical trials is expected this month.
Paradigm is 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 readout of clinical trial results is expected in December.
An exclusive licence agreement has been executed with the Icahn School of Medicine at Mount Sinai, New York.
The company’s capital position now stands at $10.5 million which provides for the preparation of regulatory filings.
The partnership with the US-based network will give Paradigm substantial exposure and access to a large patient pool.
The company is focused on repurposing PPS, an FDA approved drug.
Shares in the drug development company last traded at 73 cents before the halt.
Shares in the company have more than tripled over the past 12 months.
Data is being collected through both a clinical trial and the TGA Special Access Scheme.
The trial is being conducted at six sites in four states across Australia.
Estimated size of the osteoarthritis treatment market is US$5 billion per annum.
These patients are being treated by their doctors under the TGA Special Access Scheme.
The results readout for the study is expected during the December quarter this year.
Paradigm’s share price has increased more than 60% in the last month and it was up more than 12% on Friday.
Chris Fullerton has been appointed as a non-executive director.
Up to 50 AFL players at seven clubs are using the breakthrough pain treatment drug.
The company is repurposing the drug that has a long track record of treating inflammation.
Of 45 patients treated, 84.4% responded with a reduction in joint pain.
Paradigm is repurposing the drug that has a long track record of treating inflammation.
Osteoarthritis affects as much as 13% of the world’s population.
During 2018, Paradigm will release the results of its two phase II arthritis clinical trials.
The company is well advanced with two clinical trials aimed at diseases for which there are very few safe and effective drugs.
Paradigm aims to repurpose pentosan polysulfate sodium (PPS), an FDA-approved drug.
The placement was expanded due to strong demand from investors.
The halt will remain in place until Monday 6th November 2017.
The commencement of participant dosing follows ethics approval.
The Osteoarthritis market represents a significant opportunity for Paradigm.
Knee osteoarthritis is a condition with a significant unmet medical need.
The clinical trial is of the drug Pentosan Polysulfate Sodium for the treatment of Ross River virus.
PPS is a new multi-acting treatment for hay fever, bone bruising and viral arthritis.
PPS is a new multi-acting treatment for hay fever, bone bruising and viral arthritis
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
This will be the company's fourth active clinical trial.
Paradigm will focus on the Phase 2 Bone Marrow Edema clinical trial.
Paul Rennie is a major shareholder in the company.
Paradigm has signed a worldwide exclusive in-license agreement.
The company remains on track for its other PPS-related programs.
The halt will remain in place until Monday 19th June 2017.
The ethics approval means this is Paradigm's fourth active clinical trial.
Paul Rennie talked timeline to clinical trial results with investors.
Shares in Paradigm are trading up over 50% year to date, priced at $0.59.
First dosing in the Phase 2a clinical trial is expected during this quarter.
Find out more from Paul Rennie at Proactive's CEO Sessions.
Find out more from Andrew Beehag at Proactive's CEO Sessions.
Find out more from Robert Thomson at Proactive's CEO Sessions.
Find out more from Matthew Gill at Proactive's CEO Sessions.
The last patient in a Phase 2 hay fever trial has been treated.
Paradigm plans to conduct a clinical trial for Ross River in June 2017.
Paradigm plans to conduct a clinical trial for Ross River in June 2017.
Paradigm has been attracting the attention of brokers.
Paradigm Biopharmaceuticals (ASX:PAR) has completed the recruitment of all forty subjects in its clinical trial of Rhinosul for hay fever.
Paradigm Biopharmaceuticals Ltd (ASX:PAR) has received approval from the Swedish Medical Products Authority (MPA) to commence phase 2a allergic rhinitis trial of Rhinosul in Sweden.
Paradigm Biopharmaceuticals Ltd (ASX:PAR) has been granted a trading halt by the ASX this morning, pending details of a capital raising.