Proactiveinvestors Australia Medlab Clinical Ltd https://www.proactiveinvestors.com.au Proactiveinvestors Australia Medlab Clinical Ltd RSS feed en Wed, 24 Jul 2019 09:10:43 +1000 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Medlab Clinical achieves over $3 million revenue for June quarter, shares rise ]]> https://www.proactiveinvestors.com.au/companies/news/223313/medlab-clinical-achieves-over-3-million-revenue-for-june-quarter-shares-rise-223313.html Medlab Clinical Ltd (ASX:MDC) achieved total revenue in excess of $3 million for the June quarter representing a 135% increase on last year's June quarter.

On the research front, Medlab is focused on chronic disease markets including pain management and depression where global markets represent significant earnings opportunities.

Medlab’s patented nutraceutical product in the market, NRGBiotic™, is being evaluated as a treatment for the gut and depression – progress is steady with encouraging early data.

Research work is also progressing using its patented cannabis-based medicines NanaBis™ and NanaBidial™, which also continues to yield strong, encouraging results.

Converting research and product development into commercial success

In both nutraceutical and medical cannabis categories, significant progress has been made commercialising products through increased sales.

Medlab has its own growing distribution team together with third party distributors where appropriate to maximise the potential global market penetration.

Product range can be found in over 3,000 Australian pharmacies

Medlab’s CEO Dr Sean Hall said: “it’s apparent that a number of our clients remember me from when I coowned and managed BioCeuticals.

“Although BioCeuticals was sold several years ago, this time has given me the ability to leverage solid research into the Medlab nutraceutical range and I believe this is what sets us apart from other ranges.”

READ: Medlab Clinical signs distribution deal for NanaBis

In late May 2019, Medlabs executed a heads of agreement with Thai-listed Mega Lifesciences (BKK:MEGA) for the further global distribution of NanaBis™. 

The terms of the Heads of Agreement provide for both parties to negotiate various commercial terms involving potential global territories for NanaBis™. 

NanaBis is a highly purified proprietary blend of cannabis molecules cannabidiol (CBD) and tetrahydrocannabinol (THC).

It is delivered into the body using Medlab’s patented sub-micron delivery platform NanoCelle™.

NanaBis is a buccal (side of cheek) spray currently in the second stage of an Australian advanced cancer pain trial.

Patients can access it under the government’s Special Access Scheme and it is currently before several regulatory agencies for potential fast track drug approval pathways.

READ: Medlab Clinical receives human ethics approval for cannabis-based pain management medicine trial

Medlab has two cannabis-based medicines, NanaBis™ and NanaBidial™, which contain formulations of tetrahydrocannabinol (THC) and cannabidiol (CBD).

NanaBis™ has a 1:1 ratio of CBD:THC and NanaBidial™ has a 18:2 ratio of CBD:THC.

NanaBis™ is currently in clinical trial at Royal North Shore Hospital.

Notably, both medicines are available to Australian patients for compassionate use under the government Special Access Scheme (SAS).

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Thu, 04 Jul 2019 12:01:00 +1000 https://www.proactiveinvestors.com.au/companies/news/223313/medlab-clinical-achieves-over-3-million-revenue-for-june-quarter-shares-rise-223313.html
<![CDATA[News - Medlab Clinical receives human ethics approval for cannabis-based pain management medicine trial ]]> https://www.proactiveinvestors.com.au/companies/news/222285/medlab-clinical-receives-human-ethics-approval-for-cannabis-based-pain-management-medicine-trial-222285.html Medlab Clinical Ltd (ASX:MDC) has received human ethics approval for the second trial of its cannabis-based medicine NanaBis™.

Known as an Observational Study, the data from this study will be used to enhance regulatory package for potential drug approval.

The trial will follow how Australian doctors use NanaBis, provide patient feedback and as a result will provide valuable data aimed to support its global regulatory efforts.

The cost of the trial will be partly funded by successful participants as they will have access to NanaBis at a significantly reduced price.

READ: Medlab Clinical signs second international distribution deal for NanaBis

Medlab CEO Dr Sean Hall said: “This trial is very important to us as it allows MDC to leverage the Australian Special Access Scheme (SAS), follow the patients closely, but more-so publish and use the forthcoming data to bolster all our regulatory efforts as it relates to NanaBis.

“In talks with a number of regulatory bodies, we were offered a unique ability to use this type of data in an effort to diminish the otherwise prescribed number of people needed to finalise drug application work.

“This trial is happening in parallel to the almost completed Royal North Shore (RNS) trial.

“With regards to the work at RNS, early data received is very pleasing and this coupled with the learnings from the current Australian SAS usage, NanaBis is a strong contender for pain management and in my mind a viable pain management medication.”

 

Medlab expects to roll this trial out to 2,000 patients across Australia as quick as possible, making it one of the most significant cannabis trials to date.

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Tue, 18 Jun 2019 14:09:00 +1000 https://www.proactiveinvestors.com.au/companies/news/222285/medlab-clinical-receives-human-ethics-approval-for-cannabis-based-pain-management-medicine-trial-222285.html
<![CDATA[News - Medlab Clinical signs second international distribution deal for NanaBis ]]> https://www.proactiveinvestors.com.au/companies/news/220996/medlab-clinical-signs-second-international-distribution-deal-for-nanabis-220996.html Medlab Clinical Ltd (ASX:MDC) has executed a heads of agreement with Thai-listed Mega Lifesciences (BKK:MEGA) for the further global distribution of NanaBis™. 

The terms of the agreement provide for both parties to negotiate various commercial terms involving potential global territories for NanaBis™. 

NanaBis is a highly purified proprietary blend of cannabis molecules cannabidiol (CBD) and tetrahydrocannabinol (THC).

It is delivered into the body using Medlab’s patented sub-micron delivery platform NanoCelle™.

NanaBis is a buccal (side of cheek) spray currently in the second stage of an Australian advanced cancer pain trial.

Patients can access it under the government’s Special Access Scheme and it is currently before several regulatory agencies for potential fast track drug approval pathways.

READ: Medlab CEO presents clinical NanaBis update to medical practitioners

Medlab’s CEO Dr Sean Hall said: “NanaBis™ is in an exciting stage of its development as the company looks to fast track global drug approval pathways.

“This Heads of Agreement signifies real intent and interest for a true global pharmaceutical company to enter legitimate science as it relates to cannabis that has been research focused into a serious condition: cancer pain.

He added: “being able to collaborate with global pharmaceutical companies like Mega allows MDC the opportunity to expand NanaBis™ quicker in global territories.”

READ: Medlab Clinical collaborates with Chronic Pain Australia

Medlab has two cannabis-based medicines, NanaBis™ and NanaBidial™, which contain formulations of tetrahydrocannabinol (THC) and cannabidiol (CBD).

NanaBis™ has a 1:1 ratio of CBD:THC and NanaBidial™ has a 18:2 ratio of CBD:THC.

NanaBis™ is currently in clinical trial at Royal North Shore Hospital.

Notably, both medicines are available to Australian patients for compassionate use under the government Special Access Scheme (SAS).

Proactive caught up with Medlab earlier this month for an update.

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Tue, 28 May 2019 11:49:00 +1000 https://www.proactiveinvestors.com.au/companies/news/220996/medlab-clinical-signs-second-international-distribution-deal-for-nanabis-220996.html
<![CDATA[Media files - Medlab Clinical forges ahead in new vitamin trials for chronic illnesses ]]> https://www.proactiveinvestors.com.au/companies/stocktube/13250/medlab-clinical-forges-ahead-in-new-vitamin-trials-for-chronic-illnesses-13250.html Tue, 07 May 2019 23:30:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/13250/medlab-clinical-forges-ahead-in-new-vitamin-trials-for-chronic-illnesses-13250.html <![CDATA[News - Medlab Clinical collaborates with Chronic Pain Australia ]]> https://www.proactiveinvestors.com.au/companies/news/218633/medlab-clinical-collaborates-with-chronic-pain-australia-218633.html Medlab Clinical Ltd (ASX:MDC) has entered into a collaborative agreement with Chronic Pain Australia to promote the education of medicinal cannabis to doctors and patients.

Specifically,  to people living with chronic pain and their relevant healthcare providers.

The roll-out commences this month.

READ: Medlab CEO presents clinical NanaBis update to medical practitioners

Medlab’s CEO Dr Sean Hall said: “We openly welcome this alliance with Chronic Pain Australia, we understand that pain management has to extend beyond opioids, their derivatives, and lifestyle management; new therapies such as NanaBis™ equate to more options, and together we can work on better patient outcomes.”

Chronic Pain Australia is a not-for-profit consumer-lead organisation dedicated to reducing health and social barriers faced by people living with chronic pain.

It supports over 35,000 people living with chronic pain each month and has partnered with the Australian Pain Society and Faculty of Pain Medicine to develop Australia's first National Pain Strategy.

NanaBis™ in clinical trial at Royal North Shore Hospital

Medlab has two cannabis-based medicines, NanaBis™ and NanaBidial™, which contain formulations of tetrahydrocannabinol (THC) and cannabidiol (CBD).

NanaBis™ has a 1:1 ratio of CBD:THC and NanaBidial™ has a 18:2 ratio of CBD:THC.

NanaBis™ is currently in clinical trial at Royal North Shore Hospital.

Notably, both medicines are available to Australian patients for compassionate use under the government Special Access Scheme (SAS).

Proactive caught up with Medlab last month to get an update on the company, including NRGBiotic™, a probiotic.

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Tue, 16 Apr 2019 13:14:00 +1000 https://www.proactiveinvestors.com.au/companies/news/218633/medlab-clinical-collaborates-with-chronic-pain-australia-218633.html
<![CDATA[News - Medlab CEO presents clinical NanaBis update to medical practitioners ]]> https://www.proactiveinvestors.com.au/companies/news/216431/medlab-ceo-presents-clinical-nanabis-update-to-medical-practitioners-216431.html Medlab Clinical Ltd’s (ASX:MDC) CEO Dr Sean Hall last night, presented a clinical NanaBis update to medical practitioners as part of on-going medical education.

He explained several key aspects of NanaBis, which is a highly purified proprietary blend of cannabis molecules cannabidiol (CBD) and tetrahydrocannabinol (THC).

A summary was provided of five case studies from five different doctors that were treated with NanaBis™ in Australia under the government-approved Special Access Scheme (SAS).

Notably, the data shows significant improvements in quality of life inclusive of sleep and movement with reduced pain/restriction, reduction/replacement of previously prescribed medication (in particular opioids, reduction in pain severity scores, and reduction of symptoms.

READ: Medlab Clinical does deal for global distribution of NanaBis

Medlab noted that it is extremely pleased with the pooled data collected to date as well as the ongoing regulatory pathway for an approved drug.

NanaBis wins head-to-head with approved cannabis drug

Further to previously announced Stage 1 results, NanaBis™ data from that component of the trial was directly compared to published data for an ARTG approved Cannabis Drug.

The head to head comparison demonstrates a similar plasma level of THC and CBD with NanaBis being half the dose.

Similarly, the rate of absorption for NanaBis was faster.

Actively pursuing drug approval

Based on trial activity, Medlab is actively pursuing regulatory pathways for  TGA in Australia, FDA in the US and Europe’s EMA.

Medlab has a planned framework that should take NanaBis to an approved drug.

Proactive caught up with Dr Hall earlier this week for an update

 

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Thu, 14 Mar 2019 12:02:00 +1100 https://www.proactiveinvestors.com.au/companies/news/216431/medlab-ceo-presents-clinical-nanabis-update-to-medical-practitioners-216431.html
<![CDATA[Media files - Medlab Clinical chief updates on progress with NanaBis and NRG Biotic ]]> https://www.proactiveinvestors.com.au/companies/stocktube/12556/medlab-clinical-chief-updates-on-progress-with-nanabis-and-nrg-biotic-12556.html Tue, 12 Mar 2019 14:03:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/12556/medlab-clinical-chief-updates-on-progress-with-nanabis-and-nrg-biotic-12556.html <![CDATA[News - Medlab Clinical does deal for global distribution of NanaBis ]]> https://www.proactiveinvestors.com.au/companies/news/215761/medlab-clinical-does-deal-for-global-distribution-of-nanabis-215761.html Medlab Clinical Ltd (ASX:MDC) has entered an agreement with Canadian pharmaceutical company, Pharmascience Inc. for the further development and global distribution of NanaBis.

The terms of the HoA provide for both parties to negotiate various research, regulatory and commercial milestones involving potential global territories for NanaBis.

READ: Medlab Clinical takes EMA and FDA approval track as cannabis research continues

NanaBis is a highly purified proprietary blend of cannabis molecules cannabidiol (CBD) and tetrahydrocannabinol (THC).

It is delivered into the body using Medlab’s patented sub-micron delivery platform NanoCelle.

NanaBis is a buccal (side of cheek) spray currently in the second stage of an Australian advanced cancer pain trial.

Patients can access it under the government’s Special Access Scheme and it is currently before several regulatory agencies for potential fast track drug approval pathways.

Medlab’s CEO Dr Sean Hall said: “NanaBis is in an exciting stage of its development as the company looks to fast track global drug approval pathways.

This Heads of Agreement signifies real intent and interest for a true global pharmaceutical company to enter legitimate science as it relates to cannabis that has been research focused into a serious condition: cancer pain.

Collaborating with global companies allows faster expansion

Dr Hall added: “being able to collaborate with global pharmaceutical companies like Pharmascience Inc. allows MDC the opportunity to expand NanaBis quicker in global territories including USA and Canada”.

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Tue, 05 Mar 2019 11:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/215761/medlab-clinical-does-deal-for-global-distribution-of-nanabis-215761.html
<![CDATA[News - Medlab Clinical expands depression trial recruitment, shares open 5% higher ]]> https://www.proactiveinvestors.com.au/companies/news/214590/medlab-clinical-expands-depression-trial-recruitment-shares-open-5-higher-214590.html Medlab Clinical Ltd (ASX:MDC) opened 5% higher at 42 cents after delivering news of an expansion in recruitment for a clinical trial of its patented NRGBiotic™ to treat depression.

The second round of recruitment is underway for the Phase 2a trial led by Brisbane-located Queensland University of Technology (QUT).

This trial has already involved 32 people who experience depression and more volunteers are being sought as QUT and Medlab aim for estimated total participant numbers of 150.

Depression a global issue

The Phase 2a trial has been designed to meet TGA requirements for expedited drug approval.

Globally, more than 300 million people suffer from depression and in Australia, 45% of people aged 16-85 years have met the criteria for a diagnosis of a mental disorder at some point in their lives.

Depression, as a part of mental health, is an Australian health priority.

Principal investigator of the trial, clinical psychologist Dr Esben Strodl from QUT’s Institute of Health and Biomedical Innovation, said the study had made good progress with recruitment to date.

“With the start of a new year, a new recruitment phase is being launched with optimism of meeting recruitment targets on time.

“The research team is pleased with the current progress and outcomes of the study,” he said.

READ: Medlab Clinical signs deal to launch its nutraceuticals in Priceline Pharmacy

Since 30% of people with depression do not respond to medication, the trial is seeking to show that improving gut health with NRGBiotic™ will make standard depression medicine more effective.

Research corroborates direction

New research just published in Nature Microbiology, from a data sample of 2,000 people in Europe, shows certain strains of bacteria in the gut are depleted in people with depression.

This adds to mounting evidence of an association between gut health and the brain and corroborates earlier research by Medlab and results from its successful Phase 1 trials of NRGBiotic™.

“On the right track”

Medlab managing director Dr Sean Hall said the combination of trial expansion and recently published European research showed “we have been, and still are, on the right track.

“NRGBiotic™ (patented) is available from pharmacies so we have substantial anecdotal evidence of its positive effects but we’re taking the clinical trial route to provide scientific validation and a drug pathway.”

Dr Strodl’s co-investigators are Dr Matthew Bambling, from University of Queensland’s Faculty of Medicine, and Medlab medical director Professor Luis Vitetta.

“Great interest” in recruitment

Dr Bambling said: “Recruitment has gone very well, with great interest from the public and professions alike.

“We continuously receive enquiries from potential participants who are looking for new treatments for their depression.”

READ: Medlab Clinical takes EMA and FDA approval track as cannabis research continues

Medlab Clinical, an Australian-based medical life science company, is developing therapeutic pathways for diagnosed chronic diseases.

It is advanced in developing therapies for pain management, depression and obesity as well as earning revenue from the sale of nutritional products in Australia and the United States.

In pain management, Medlab is developing cannabis-based medicines.

The Medlab developed nano-particle medicine delivery system, Nanocelle™, is being applied to its medicines, nutritional products and off-patent drugs like statins.

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Thu, 14 Feb 2019 10:39:00 +1100 https://www.proactiveinvestors.com.au/companies/news/214590/medlab-clinical-expands-depression-trial-recruitment-shares-open-5-higher-214590.html
<![CDATA[Media files - Medlab Clinical accelerating VMS business in Australia, and NanaBis globally ]]> https://www.proactiveinvestors.com.au/companies/stocktube/12132/medlab-clinical-accelerating-vms-business-in-australia-and-nanabis-globally-12132.html Thu, 07 Feb 2019 15:16:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/12132/medlab-clinical-accelerating-vms-business-in-australia-and-nanabis-globally-12132.html <![CDATA[News - Medlab Clinical signs deal to launch its nutraceuticals in Priceline Pharmacy ]]> https://www.proactiveinvestors.com.au/companies/news/213564/medlab-clinical-signs-deal-to-launch-its-nutraceuticals-in-priceline-pharmacy-213564.html Medlab Clinical Ltd (ASX:MDC) has signed an agreement with Australian Pharmaceutical Industries (API) to range Medlab’s nutraceuticals in Priceline Pharmacy, one of Australia’s biggest pharmacy groups.

As part of the agreement, API will also hold Medlab products in its warehouses, significantly expanding potential distribution to more than 2100 independent pharmacies who will now be able to easily access the product range.

READ: Medlab Clinical takes EMA and FDA approval track as cannabis research continues

The agreement positions Medlab’s nutraceutical range into professional pharmacy with onboarding expected to take 3-4 months.

It is anticipated these agreements will result in a substantial increase in sales in the 12-month period from official launch.

 

Medlab’s nutraceutical offering differs from general retail due to its exposure to clinical research and patents.

The company currently has 27 patents covering a large number of products in the nutraceutical range.

Included within the range are NanoCelle™ products which were developed using Medlab’s patented delivery platform.

READ: Medlab Clinical eyes cost savings following receipt of SME status in Europe

Medlab chief executive officer Dr Sean Hall said: “Medlab is very excited with this opportunity to work with Priceline Pharmacy and other independent groups as it allows us to support people in the community suffering chronic illnesses by providing them easier access to scientifically backed products via professional pharmacy.”

Medlab is expected to exhibit at this year’s largest pharmacy conference, APP on the Gold Coast in March.

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Wed, 30 Jan 2019 12:14:00 +1100 https://www.proactiveinvestors.com.au/companies/news/213564/medlab-clinical-signs-deal-to-launch-its-nutraceuticals-in-priceline-pharmacy-213564.html
<![CDATA[News - Medlab Clinical takes EMA and FDA approval track as cannabis research continues ]]> https://www.proactiveinvestors.com.au/companies/news/213022/medlab-clinical-takes-ema-and-fda-approval-track-as-cannabis-research-continues-213022.html Medlab Clinical Ltd (ASX:MDC) is commercialising a therapeutics pipeline with four strategic pillars as the cannabis drug developer aims to help patients with diagnosed chronic diseases.

The New South Wales life sciences company is also advancing its NanoCelle particle-spray medicines delivery platform and developing bacteria-based medicines based on the human genome.

Medlab has a product suite of 40 nutraceutical products, with 30 being sold nationally at more than 600 chemists.

READ: Medlab Clinical eyes cost savings following receipt of SME status in Europe

Medlab is based in the Sydney suburb of Alexandria, with one of its cancer therapeutic products being studied at the city’s Royal North Shore Hospital in St Leonards.

The phase I study is being led by Professor Stephen Clarke and has reached the second stage of the research.

The safety, tolerability and exploratory end-point pilot study is assessing the administration of a cannabis extract as an adjunct to opioid analgesia for the management of intractable pain in patients with advanced cancer.

Patients are being dosed with the extract using a buccal spray delivery system.

Recruitment of patients has already taken place and study participants have progressed through stage I — recruitment and dosing of the patients with standard dosings of 2.6 milligrams of tetrahydrocannabinol (THC) and 2.4 milligrams of cannabidiol (CBD) in 0.3 millilitres, up to three times a day.

The THC-CBD therapeutic is part of the NanaBis program Medlab hopes to eventually present for registration as a drug rather than a medicinal product.

Under the program, the NanaBis product has a 1:1 ratio of CBD:THC and NanaBidial has a 18:2 ratio of CBD:THC.

The products are available to Australian patients through a compassionate use allowance that was authorised by the Federal Government through its Special Access Scheme (SAS).

Medlab managing director & CEO Sean Hall spoke to Proactive Investors Stocktube video channel about the medicinal product study and drug delivery mechanism in November 2018, saying the company had received “some good safety data” out of the NanaBis program phase I research.

Speaking of the stage I part of the clinical trial, Hall said: “We can see how effective the product is, how long it lasts in the body, when it gets to peak concentration.”

Stage II research, which is underway, involves standard dosings every four hours on day one, which is then graduated up to three standard dosings every four hours by day seven and maintained until day 15.

Medlab hopes the treatment may prove beneficial for treating intractable pain in cancer patients in conjunction with conventional opioid treatments.

Hall highlighted the company’s end game, saying: “Remember, our endpoint for NanaBis, is as a registered drug, not as a medicinal product going forward.”

 

READ: Medlab Clinical eyes cost savings following receipt of SME status in Europe

The company is determined to follow NanaBis program approvals processes with the US Food and Drug Administration (US FDA) and the EU’s European Medicines Agency (EMA).

Hall said: “We’re entering that stage where NanaBis needs to be considered for drug registration.”

In Australia, Medlab is collaborating with national clinical groups, patient support organisations and collating efficacy and medication substitution data from doctors and pharmacists.

Meanwhile in Europe, Medlab’s European subsidiary last week received formal SME (small or medium-sized enterprise) qualification from EMA.

The subsidiary can now apply for scientific advice, drug evaluation and registration of NanaBis, and up to 90% fee reductions during the regulatory assessment and approvals process.

READ: Medlab Clinical receives preliminary results from NanoStat trial

Another study of interest to Medlab’s investors is the NanoStat trial undertaken by Zenith in New Zealand.

The investigator studied the capability of the NanoStat investigative sub-micron spray in delivering four pumps of the cholesterol-lowering Atorvastatin statin to the skin inside the mouth.

Atorvastatin is usually delivered in tablet form.

Medlab hopes to use the NanoStat drug delivery platform for medicinal cannabis therapeutics delivery.

Hall spoke to Proactive Investors’ Stocktube channel on November 1, 2018, and indicated the company’s treatments could be extended from use as pain treatments to become options for patients with other chronic diseases such as type II diabetes and depression.

A NanaBidial clinical trial studying the buccal administration of a nanocelle CBD preparation to healthy volunteers received National Institute of Integrative Medicine approval in August 2018.

First patients for the safety, tolerability and pharmacokinetic exploratory pilot study are expected to be recruited at Scientia Clinical Research in the Sydney suburb of Randwick from February 2019 onwards.

The NanaBidial formulation will be the standard ratio of about 18 parts CBD to one part THC.

 

Medlab outlined its business objectives during an open day at its facility last month.

Hosted by commercial operations director Paul Vilner, investors were reminded of the four strategic pillars the company planned to commercialise.

The company has 30 neutraceutical products containing standardised nutrients and pharmaceutical grade ingredients.

They are available in more than 600 Australian pharmacies.

Medlab also has 10 neutraceuticals in development.

— with Ky Chow

READ: Medlab outlines business development objectives at open day

 

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Tue, 22 Jan 2019 16:30:00 +1100 https://www.proactiveinvestors.com.au/companies/news/213022/medlab-clinical-takes-ema-and-fda-approval-track-as-cannabis-research-continues-213022.html
<![CDATA[News - Medlab Clinical eyes cost savings following receipt of SME status in Europe ]]> https://www.proactiveinvestors.com.au/companies/news/212744/medlab-clinical-eyes-cost-savings-following-receipt-of-sme-status-in-europe-212744.html Medlab Clinical Ltd’s (ASX:MDC) European subsidiary has received formal SME (small or medium-sized enterprise) qualification from European Medicines Agency (EMA).

EMA is the European equivalent to the Australian TGA and the US FDA. As part of the registration, this allows MDC to apply for scientific advice, drug evaluation and registration of NanaBis.

It also provides MDC with the opportunity to obtain fee reductions up to 90% in the process.

NanaBi is a cannabis-based medicine which contains formulations of tetrahydrocannabinol (THC) and cannabidiol (CBD).

 

Medlab chief executive officer Dr Sean Hall said: “This is a significant milestone for MDC. Drug registration of NanaBi is key part of the company’s plans and this qualification allows us to start the process into Europe.

“Drug evaluation and registration fees with the various agencies are expensive, but at the same time, a much needed and real cost in bringing a drug to market and we welcome the opportunity obtain fee reductions and as a result significant savings.

“Personally, I would like to thank EMA for their collaborative approach in this regard, and very much look forward to escalating the NanaBis evaluation with EMA as we move closer to an approved drug in the EU.”

READ: Medlab Clinical proceeding to stage 2 for cannabis cancer trial

In late October 2018, Medlab successfully completed stage 1 of the NanaBis human trial on cancer patients at Royal North Shore Hospital.

The trial is progressing as planned and currently in stage II of the ethics approved trial.

READ: Medlab Clinical receives preliminary results from NanoStat™ trial ]]>
Thu, 17 Jan 2019 16:09:00 +1100 https://www.proactiveinvestors.com.au/companies/news/212744/medlab-clinical-eyes-cost-savings-following-receipt-of-sme-status-in-europe-212744.html
<![CDATA[News - Medlab Clinical receives preliminary results from NanoStat trial ]]> https://www.proactiveinvestors.com.au/companies/news/212190/medlab-clinical-receives-preliminary-results-from-nanostat-trial-212190.html Medlab Clinical Ltd (ASX:MDC) has received and analysed the results of the NanoStat trial from Zenith in New Zealand. 

NanoStat is an investigative new sub-micron spray delivering a dosage of Atorvastatin in four pumps applied to the oro-buccal membrane (skin inside the mouth).

Atorvastatin is a statin medication used to lower cholesterol and was selected as it had specific comparative benefits when being tested in Medlab’s drug delivery platform (mouth spray).

Atorvastatin is predominantly provided to patients in tablet form.

Medlab aims to deliver medicinal cannabis using this drug delivery platform.

READ: Medlab outlines business development objectives at open day

Medlab’s CEO Dr Sean Hall said: “For those who recall why we undertook NanoCelle work with Atorvastatin, Atorvastatin had inherent properties that would test the NanoCelle capabilities beyond most generic drugs and our cannabis programs.

“These results further show the potential and widespread capabilities of the NanoCelle delivery platform.”

Post-results work shows benefits of spray over tablet ingestion

In work undertaken at our main laboratory in Alexandria post results, Medlab has improved NanoStat with data now indicating a 2 + times better blood level of free atorvastatin compared to the oral ingested Atorvastatin tablet.

Further, the work demonstrated that peak blood concentrations of free Atorvastatin was achieved in about 30 minutes, as previously compared to 53 minutes on the oral tablet.

Medlab considers the data extremely interesting as it has highlighted several areas of improvement which had previously not been obvious.

Moving forward Medlab intends to perfect this technique, develop the product further and look for potential new patents for Atorvastatin in light of the program findings to date.

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Wed, 09 Jan 2019 11:07:00 +1100 https://www.proactiveinvestors.com.au/companies/news/212190/medlab-clinical-receives-preliminary-results-from-nanostat-trial-212190.html
<![CDATA[Media files - MedLab Clinical plans European product expansion with wholly-owned subsidiary ]]> https://www.proactiveinvestors.com.au/companies/stocktube/11604/medlab-clinical-plans-european-product-expansion-with-wholly-owned-subsidiary-11604.html Wed, 12 Dec 2018 23:38:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/11604/medlab-clinical-plans-european-product-expansion-with-wholly-owned-subsidiary-11604.html <![CDATA[News - Medlab outlines business development objectives at open day ]]> https://www.proactiveinvestors.com.au/companies/news/210537/medlab-outlines-business-development-objectives-at-open-day-210537.html Medlab Clinical Ltd’s (ASX:MDC) director of commercial operations Paul Vilner has outlined its business development objectives at its open day held at the Sydney suburb of Alexandria.

It plans to commercialise each of its four strategic pillars.

READ: Medlab Clinical expanding cannabis-based medicines into Europe

Medlab has 30 nutraceutical products (pharmaceutical-grade and standardised nutrients) globally, with another 10 in development.

Most of these products are sold as a companion to a prescription product and are available in over 600 pharmacies across Australia.

Pharmaceutical product range

Medlab has two cannabis-based medicines, NanaBis™ and NanaBidial™, which contain formulations of tetrahydrocannabinol (THC) and cannabidiol (CBD).

NanaBis™ has a 1:1 ratio of CBD:THC and NanaBidial™ has a 18:2 ratio of CBD:THC.

NanaBis™ and NanaBidial™ available to Australian patients for compassionate use under the government Special Access Scheme (SAS).

Spreading awareness of ability to access

Medlab has a dedicated team of medical specialist liaisons to support healthcare practitioners with patient initiation, SAS-B applications and clinical trial recruitment.

The company is actively collaborating with national clinical groups (RACGP) and patient support organisations (Chronic Pain Australia).

To date, doctors and pharmacists are reporting encouraging results, in both efficacy and medication substitution.

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Wed, 05 Dec 2018 15:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/210537/medlab-outlines-business-development-objectives-at-open-day-210537.html
<![CDATA[News - Medlab Clinical expanding cannabis-based medicines into Europe ]]> https://www.proactiveinvestors.com.au/companies/news/210430/medlab-clinical-expanding-cannabis-based-medicines-into-europe-210430.html Medlab Clinical Ltd (ASX:MDC) has formally incorporated a wholly owned subsidiary MDC Europe Limited to facilitate expansion into Europe.

The subsidiary will be used specifically for current and future dealings regarding NanaBis™ and the proposed drug registration models as per the European Medicines Agency (EMA). 

NanaBis™ is one of two of Medlab’s cannabis-based medicines which contains formulations of tetrahydrocannabinol (THC) and cannabidiol (CBD).

European registration of NanaBis™ progressing

Meetings have been held with EMA on the pathway for registration of NanaBis™.

Conditional approval is likely. Registration with a significant fee reduction requires the company to be domiciled in Europe.

Medlab’s CEO Dr Sean Hall said: “MDC as a Group is strategically placed to progress commerce in Europe through potential trade deals, especially in conjunction with the recently announced granting of an export licence for NanaBis™.

“This move is also very exciting as it provides NanaBis™ an introduction into Europe as a potentially future compliant drug.” 

READ: Medlab Clinical proceeding to stage II for cannabis cancer trial

In late October 2018, Medlab successfully completed stage I of the NanaBis™ human trial on cancer patients at Royal North Shore Hospital.

The trial is progressing as planned and currently in stage II of the Ethics approved trial.

This NanaBis™ program will serve as an integral part of both domestic and foreign regulatory approvals.

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Tue, 04 Dec 2018 12:22:00 +1100 https://www.proactiveinvestors.com.au/companies/news/210430/medlab-clinical-expanding-cannabis-based-medicines-into-europe-210430.html
<![CDATA[Media files - Medlab Clinical progresses through trials, overseas registration process ]]> https://www.proactiveinvestors.com.au/companies/stocktube/11071/medlab-clinical-progresses-through-trials-overseas-registration-process-11071.html Thu, 01 Nov 2018 12:35:00 +1100 https://www.proactiveinvestors.com.au/companies/stocktube/11071/medlab-clinical-progresses-through-trials-overseas-registration-process-11071.html <![CDATA[News - Medlab Clinical substantial shareholder Farjoy lifts holding through on-market purchases ]]> https://www.proactiveinvestors.com.au/companies/news/208178/medlab-clinical-substantial-shareholder-farjoy-lifts-holding-through-on-market-purchases-208178.html Medlab Clinical Ltd (ASX:MDC) substantial shareholder Farjoy Pty Ltd has increased its holding in the company through a series of on-market purchases.

The Sydney-based investor now holds almost 24 million shares, or 11.53%, of Medlab, up from 10.51%.

Since 17 August 2018, Farjoy has acquired more than 2.123 million shares on-market at prices ranging from 34 cents to 43 cents.

The total value of these acquisitions is almost $840,000.

Medlab has various research and development programs focused on delivering therapies for a range of chronic conditions.

As well as developing bacteria-based medicines for treating depression, diabetes and chronic kidney disease, Medlab has developed two cannabis-based medicines for oncology patients.

READ: Medlab Clinical proceeding to stage II for cannabis cancer trial

This week the company announced that it has completed stage I of the NanaBis™ human trial on cancer patients at Sydney’s Royal North Shore Hospital.

NanaBis™ is one of two of Medlab’s cannabis-based medicines which contains formulations of tetrahydrocannabinol (THC) and cannabidiol (CBD).

Medlab has received formal approval from the appropriate authority to proceed to stage II of the human cancer clinical trial, which will focus on further safety but also tolerance and dose escalation.

Key data findings from stage I include that NanaBis™ is safe, is effective up to nine hours in a single dose, and early indications confirm it helps with pain reduction.

In stage II, Medlab will continue with cancer patients but this time with unmanaged pain.

READ: Medlab Clinical receives positive early research results for NanoCelle™

In September, the company received preliminary results from research reviewing its patented delivery platform, NanoCelle™.

NanoCelle™ delivers medicine in a tiny particle form in a spray into the mouth and it is being tested using Medlab’s cannabis-based medicines, NanaBis™ and NanaBidial™.

The research concluded positively that molecules of the medicines, NanaBis™ and NanaBidial™ showed a consistent uniform pattern in nanoparticle form.

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Wed, 31 Oct 2018 12:10:00 +1100 https://www.proactiveinvestors.com.au/companies/news/208178/medlab-clinical-substantial-shareholder-farjoy-lifts-holding-through-on-market-purchases-208178.html
<![CDATA[News - Medlab Clinical proceeding to stage II for cannabis cancer trial ]]> https://www.proactiveinvestors.com.au/companies/news/208069/medlab-clinical-proceeding-to-stage-ii-for-cannabis-cancer-trial-208069.html Medlab Clinical Ltd (ASX:MDC) has successfully completed stage I of the NanaBis™ human trial on cancer patients at Royal North Shore Hospital.

NanaBis™ is one of two of Medlab’s cannabis-based medicines which contains formulations of tetrahydrocannabinol (THC) and cannabidiol (CBD).

Medlab has received formal approval from the appropriate authority to proceed to stage II of the human cancer trial. 

Stage II of the clinical trial will focus on further safety but also tolerance and dose escalation.

READ: Medlab Clinical receives vital licence to export cannabis

Key data findings from stage I include that NanaBis™ is safe, is effective up to nine hours in a single dose, and early indications confirm it helps with pain reduction.

Medlab’s CEO Dr Sean Hall said: “These results confirm and validate our original hypothesis and offer a true alternative to current pain medications.

“I’m looking forward to data from stage II.

“Although pain measurement was not a key part of stage I, the early results of pain reduction while being administered NanaBis™ was very encouraging.”

In stage II, Medlab will continue with cancer patients but this time with unmanaged pain.

READ: Medlab Clinical receives positive early research results for NanoCelle™

In September, Medlab received preliminary results from research reviewing its patented delivery platform, NanoCelle™.

NanoCelle™ delivers medicine in a tiny particle form in a spray into the mouth and it is being tested using Medlab’s cannabis-based medicines, NanaBis™ and NanaBidial™.

The research concluded positively that molecules of the medicines, NanaBis™ and NanaBidial™ showed a consistent uniform pattern in nanoparticle form.

The type of work is critical as Medlab furthers its research endeavours for accepted, approved pharmaceuticals.

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Tue, 30 Oct 2018 09:10:00 +1100 https://www.proactiveinvestors.com.au/companies/news/208069/medlab-clinical-proceeding-to-stage-ii-for-cannabis-cancer-trial-208069.html
<![CDATA[Media files - Medlab's Hall: "Time to offer something new" to challenge reliance on opioids ]]> https://www.proactiveinvestors.com.au/companies/stocktube/10616/medlab-s-hall-time-to-offer-something-new-to-challenge-reliance-on-opioids-10616.html Wed, 26 Sep 2018 11:18:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/10616/medlab-s-hall-time-to-offer-something-new-to-challenge-reliance-on-opioids-10616.html <![CDATA[News - Medlab Clinical receives vital licence to export cannabis ]]> https://www.proactiveinvestors.com.au/companies/news/204575/medlab-clinical-receives-vital-licence-to-export-cannabis-204575.html Medlab Clinical Ltd (ASX:MDC) has received a Licence to Export Cannabis from Australia’s Office of Drug Control.

The export licence will allow Medlab to undertake more formal overseas trade conversations with confidence in the knowledge that the company can now supply legally overseas.

Medlab’s CEO Dr Sean Hall said: “This Licence is a welcome addition to our other approvals, allowing Medlab to research, manufacture, conduct research trials, supply within Australia, and now, pending the right partner, foreign markets.”

WATCH: Medlab's Hall: "Time to offer something new" to challenge reliance on opioids

Medlab has developed two cannabis-based medicines, NanaBis™ and NanaBidial™, which contains formulations of tetrahydrocannabinol (THC) and cannabidiol (CBD).

NanaBis™ has a 1:1 ratio of CBD:THC and NanaBidial™ has a 18:2 ratio of CBD:THC.

Medlab also has a patented delivery platform called NanoCelle™ which delivers medicine in a tiny particle form in a spray into the mouth.

Recently Medlab received preliminary results from the University of Sydney’s Nano Institute, School of Pharmacy validating the science behind the NanoCelle™ delivery platform.

READ: Medlab Clinical Ltd advances research amid nutraceuticals revenue growth

Medlab is developing therapies for pain management, depression and obesity as well as earning revenue from sale of nutritional products in Australia and the United States.

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Tue, 11 Sep 2018 09:43:00 +1000 https://www.proactiveinvestors.com.au/companies/news/204575/medlab-clinical-receives-vital-licence-to-export-cannabis-204575.html
<![CDATA[News - Medlab Clinical receives positive early research results for NanoCelle™ ]]> https://www.proactiveinvestors.com.au/companies/news/204086/medlab-clinical-receives-positive-early-research-results-for-nanocelle-204086.html Medlab Clinical Ltd (ASX:MDC) has received preliminary results from research underway that is reviewing its patented delivery platform, NanoCelle™.

NanoCelle™ delivers medicine in a tiny particle form in a spray into the mouth and it is being tested using Medlab’s cannabis-based medicines, NanaBis™ and NanaBidial™. 

The research has concluded positively that molecules of the medicines, NanaBis™ and NanaBidial™ showed a consistent uniform pattern in nanoparticle form.

The type of work is critical as Medlab furthers its research endeavours for accepted, approved pharmaceuticals.

READ: Medlab Clinical advances research amid nutraceuticals revenue growth

Medlab’s CEO Dr Sean Hall said: “These results provide a significant level of confidence in Medlab’s NanoCelle™ platform and further confirms specific proposed functions for Medlab’s cannabis medicines.

“These results in conjunction with the early positive feedback from doctors prescribing NanaBis™ under the TGA’s Special Access Scheme, gives Medlab great confidence in its NanoCelle™ research.”

The Special Access Scheme allows Medlab to supply NanaBis™, with NanoCelle™, to prescribing doctors.

Research conducted by University of Sydney

The research is being conducted by the University of Sydney’s Nano Institute, School of Pharmacy.

The difference between Medlab's two cannabis-based medicines, NanaBis™ and NanaBidial™, is their formulation of tetrahydrocannabinol (THC) and cannabidiol (CBD).

NanaBis™ has a 1:1 ratio of CBD:THC and NanaBidial™ has a 18:2 ratio of CBD:THC.

 

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Tue, 04 Sep 2018 12:37:00 +1000 https://www.proactiveinvestors.com.au/companies/news/204086/medlab-clinical-receives-positive-early-research-results-for-nanocelle-204086.html
<![CDATA[News - Medlab Clinical Ltd advances research amid nutraceuticals revenue growth ]]> https://www.proactiveinvestors.com.au/companies/news/203955/medlab-clinical-ltd-advances-research-amid-nutraceuticals-revenue-growth-203955.html Medlab Clinical Ltd (ASX:MDC) has increased annual revenues by 25% to $5.5 million while increasing its net tangible assets per security by 518% to 10.5 cents.

The results came on the back of a 25% increase in net loss to $4.6 million.

Medlab reported the net loss increase was due to the accelerated costs of its research projects, with some up to 18 months ahead of schedule, and NanaBis costs related to the Federal Government’s Special Access Scheme (SAS).

Cash receipts were up 47% as the company ended June 30 with a $20.3 million cash balance.

 

Financial year standouts

Medlab managing director Sean Hall reported the company made a number of achievements in the 2017-18 financial year in its nutraceutical business and its research.

These included receiving a licence to sell or supply a schedule 8 or schedule 9 drugs which was limited to cannabis and its derivatives.

The company also progressed its Phase 1/2a clinical trial of cannabis cannabidiol/tetrahydrocannabinol (CBD/THC) therapy NanaBis in seriously ill cancer patients at Sydney’s Royal North Shore Hospital, with the trial now underway.

The product was licensed for supply, along with fellow cannabis CBD product NanaBidial, through the Australian Government’s access scheme SAS.

Positive “exciting” data began to be returned from doctors prescribing NanaBis.

READ: Medlab Clinical to begin clinical trial of nutraceutical product in oncology patients

Another trial, Phase 2a clinical trial of NRGBiotic probiotic in depression, was also underway, at Queensland University of Technology Brisbane.

Medlab’s nutraceutical business continuing to grow by gaining recognition in professional pharmacy spaces.

The company upped revenues in the complementary business to its therapeutics program by 26% while keeping a lid on operating expenses.

Medlab chairman Michael Hall reported a third trial was being prepared for, a Phase 2a study of the T2Biotc in obese and diabetic patients, as a follow-on to the completed Phase1a trial.

READ: Medlab Clinical substantial shareholder Farjoy demonstrates confidence in medical research strategy

Managing director Hall said: “Medlab’s strategy is to pursue meaningful discussions with major pharmaceutical companies to have them appreciate our potential, leading to possible favourable financial outcomes for shareholders.

“Events during these past three years have supported our concentration on chronic illnesses.”

He pointed to the overuse of opioids, and deaths from their use, and the costs of depression, mental illness and obesity as illnesses and crises the company could respond to.

Hall said the company had made good progress towards achieving the goals it set at the time of listing on the Australian Securities Exchange.

READ: Medlab Clinical receives large shipment of cannabis oil for human trials

He argued the company’s research was a market differentiator that set Medlab apart from other organisations.

Hall said: “R&D is the driver of potential from its focus on chronic diseases while nutraceutical sales assist cash flow funding of Medlab’s programs.”

He highlighted the company had received human ethics approval for a trial of Medlab’s commercialised MultiBiotic product as a treatment for mucositis.

Mucositis is the painful condition where the mucous membranes lining the digestive tract become inflamed and ulcerate, usually after chemotherapy or radiotherapy treatment for cancer.

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Fri, 31 Aug 2018 17:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/203955/medlab-clinical-ltd-advances-research-amid-nutraceuticals-revenue-growth-203955.html
<![CDATA[Media files - Medlab Clinical researching links between gut microbiome and multiple chronic diseases ]]> https://www.proactiveinvestors.com.au/companies/stocktube/10248/medlab-clinical-researching-links-between-gut-microbiome-and-multiple-chronic-diseases-10248.html Mon, 27 Aug 2018 14:45:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/10248/medlab-clinical-researching-links-between-gut-microbiome-and-multiple-chronic-diseases-10248.html <![CDATA[News - Medlab Clinical to begin clinical trial of nutraceutical product in oncology patients ]]> https://www.proactiveinvestors.com.au/companies/news/203610/medlab-clinical-to-begin-clinical-trial-of-nutraceutical-product-in-oncology-patients-203610.html Medlab Clinical Ltd (ASX:MDC) is commencing a safety study for oncology patients undergoing chemotherapy using its patented nutraceutical product, Multibiotic™.

Multibiotic is a multi-species probiotic that helps to support the natural balance of commensal bacteria in the gastrointestinal tract.

It is currently in the market and is used to improve symptoms of medically diagnosed irritable bowel syndrome.

Medlab was granted ethics approval in May and has now received a clinical trial number (CTN) from the Australian Therapeutic Goods Administration enabling the commencement of the oncology trial.

The phase I clinical trial will focus on safety and tolerability for oncology patients throughout their chemotherapy treatment in reducing intestinal inflammatory ulcerations (mucositis), which leads to the development of diarrhoea and other intestinal adverse effects.

The 12-week trial will be led by professor Stephen Clarke at the Northern Cancer Institute in St Leonards, New South Wales.

 

According to Medlab chief executive officer, Dr Sean Hall, preliminary investigations have shown promising results in the oncology area, with Multibiotic™ potentially complementing other Medlab oncology products like NanaBis™ and NanaBidial™.

Hall added “Since mucositis is common and debilitating, it means it is a significant market globally and we are hoping this research will help improve the general wellbeing of chemotherapy patients.”

READ: Medlab Clinical on schedule with medicinal cannabis cancer trial

In other oncology work, Medlab has developed two cannabis-based medicines for oncology patients, one in pain management and the other in seizures, nausea and vomiting, with the first undergoing a clinical trial with seriously ill cancer patients at Royal North Shore Hospital in Sydney.

In the cannabis clinical trial, Medlab’s NanaBis™ is being administered by Medlab’s small particle medicine delivery platform, NanoCelle™.

READ: Medlab Clinical receives large shipment of cannabis oil for human trials ]]>
Mon, 27 Aug 2018 12:45:00 +1000 https://www.proactiveinvestors.com.au/companies/news/203610/medlab-clinical-to-begin-clinical-trial-of-nutraceutical-product-in-oncology-patients-203610.html
<![CDATA[News - Medlab Clinical substantial shareholder Farjoy demonstrates confidence in medical research strategy ]]> https://www.proactiveinvestors.com.au/companies/news/203105/medlab-clinical-substantial-shareholder-farjoy-demonstrates-confidence-in-medical-research-strategy-203105.html Medlab Clinical Ltd (ASX:MDC) substantial shareholder Farjoy Pty Ltd has demonstrated confidence in the company’s medical research and development strategy by lifting its interest to 10.51% from 9.33%.

The Sydney-based investor has made a series of recent on-market purchases and also participated in a Medlab placement.

Farjoy acquired more than 4.1 million shares valued at almost $3.7 million in the placement and has made on-market purchases totalling 800,000 shares valued at more than $357,000.

It now holds more than 21.855 million shares, up from 15 million.

 

Medlab has various research and development programs focused on delivering therapies for a range of chronic conditions.

As well as developing bacteria-based medicines for treating depression, diabetes and chronic kidney disease, Medlab has developed two cannabis-based medicines for oncology patients.

READ: Medlab Clinical receives large shipment of cannabis oil for human trials

The company recently received a large shipment of cannabis oil for use in human trials.

Medlab has also started a recruitment campaign for participants in a clinical trial of a medicine for the treatment of depression.

The trial is being led by Queensland University of Technology in Brisbane which is running the recruitment campaign.

READ: Medlab Clinical begins recruitment for phase IIa clinical trial for depression medicine

Two phase I trials have already shown significant patient improvement on the combination of Medlab’s NRGBiotic™ product with a standard anti-depressant medicine.

The phase IIa study is designed to strengthen those initial findings in a wider group of patients, with the recruitment campaign intended to enrol 150 people diagnosed with depression.

This trial design is intended to meet the requirements of a new expedited drug approval mechanism being developed by the Department of Health’s Therapeutic Goods Administration (TGA) to provide faster access to new medicines which have a community benefit.

Other recent Farjoy investments

Farjoy has also made other recent strategic investments, including in audio wearables company Nuheara Ltd (ASX:NUH) and in the in-demand tech metal of graphite through Battery Minerals Ltd (ASX:BAT).

It became a substantial shareholder in Nuheara in June with a 5.28% interest, mostly accumulated in a placement in which it invested $4 million.

Nuheara develops proprietary hardware and software to deliver multi-functional intelligent hearing technology, including IQbuds, wireless earbuds that connect hands-free with voice-enabled smart devices.

Farjoy recently increased its interest in Battery Minerals to 16.1% primarily through participation in a placement by investing $5 million.

This company is primarily engaged in graphite exploration in East Africa with interests in the Montepuez graphite and Balama Central graphite projects in Mozambique.

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Fri, 17 Aug 2018 14:48:00 +1000 https://www.proactiveinvestors.com.au/companies/news/203105/medlab-clinical-substantial-shareholder-farjoy-demonstrates-confidence-in-medical-research-strategy-203105.html
<![CDATA[Media files - Medlab Clinical has in place 'the fundamentals to a very successful future' ]]> https://www.proactiveinvestors.com.au/companies/stocktube/10045/medlab-clinical-has-in-place-the-fundamentals-to-a-very-successful-future--10045.html Mon, 06 Aug 2018 16:27:00 +1000 https://www.proactiveinvestors.com.au/companies/stocktube/10045/medlab-clinical-has-in-place-the-fundamentals-to-a-very-successful-future--10045.html <![CDATA[News - Medlab Clinical receives large shipment of cannabis oil for human trials ]]> https://www.proactiveinvestors.com.au/companies/news/201697/medlab-clinical-receives-large-shipment-of-cannabis-oil-for-human-trials-201697.html Medlab Clinical Ltd (ASX:MDC) is set to receive its largest international shipment of cannabis oil to date from Aphria Inc. (TSE:APH).

The shipment is part of an agreement between Aphria and Medlab in which Aphria produces and supplies high-yield cannabis extracts for Medlab to be used in human trials.

Trials are testing the management of intractable pain in oncology patients and is the first trial of its kind globally.

For the purposes of the clinical trial, Medlab will receive a specifically designed high-CBD cannabis oil and a high-THC cannabis oil.

READ: Medlab Clinical begins recruitment for phase IIa clinical trial for depression medicine

Medlab will combine the products with its patented medicine delivery system, NanoCelle™.

Medlab’s clinical trial is posited to provide an effective and efficacious pain therapy targeted to advanced cancer pain, that rivals standard opioid use.

The product formulation, manufacturing, and final product validation have met the TGO93 standard set by the Australian Therapeutic Goods Administration (TGA) and permits have been approved by Health Canada.

READ: Medlab Clinical on schedule with medicinal cannabis cancer trial

Medlab’s CEO Dr Sean Hall said: “Trial design, implementation and management is critical to developing a new, accepted drug – the work we are undertaking is to expand the medical toolkit especially with regards to current usage of opioids in patients with intractable pain.

“Trial work is progressing with recruitment underway, further patients accessing the trial product (NanaBis™) under the Australian Special Access Scheme (SAS) is providing early, exciting and promising results.”

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Fri, 27 Jul 2018 11:48:00 +1000 https://www.proactiveinvestors.com.au/companies/news/201697/medlab-clinical-receives-large-shipment-of-cannabis-oil-for-human-trials-201697.html
<![CDATA[News - Medlab Clinical begins recruitment for phase IIa clinical trial for depression medicine ]]> https://www.proactiveinvestors.com.au/companies/news/201494/medlab-clinical-begins-recruitment-for-phase-iia-clinical-trial-for-depression-medicine-201494.html Medlab Clinical Ltd (ASX:MDC) has commenced a recruitment campaign for participants in a clinical trial of a medicine for the treatment of depression.

The trial is being led by Queensland University of Technology (QUT) in Brisbane which is running the recruitment campaign.

Notably, two phase I trials have already shown significant patient improvement on the combination of Medlab’s NRGBiotic™ product with a standard anti-depressant medicine.

READ: Medlab Clinical Ltd initiates phase IIa after positive anti-depression results

The phase IIa study is designed to strengthen those initial findings in a wider group of patients, with the recruitment campaign intended to enrol 150 people diagnosed with depression.

Medlab’s trial design is intended to meet the requirements of a new expedited drug approval mechanism being developed by the Department of Health’s Therapeutic Goods Administration (TGA) to provide faster access to new medicines which have a community benefit.

The company has already received approval of a grant from the Federal government towards the cost of this trial.

The research underlying the trial is based on a connection between gut health and inflammation and its subsequent effect on mental health.

 

#SavingLivesSavingMoney, #MHV's new report, sets out the case investment in #Victoria's #mentalhealth system and challenges the next Victorian Government to do better than "below average" in mental health support #springst https://t.co/BU76q3q884 pic.twitter.com/7hdHhGSJ3p

— Mental Health Victoria (@MentalHealthVic) July 3, 2018

 

Globally, more than 300 million people suffer from depression.

In Australia, 45% of people aged 16-85 years have met the criteria for a diagnosis of a mental disorder at some point in their lives and the annual cost of mental illness is $20 billion.

Medlab managing director Dr Sean Hall said there was a clear community need to develop more effective medicines for the treatment of depression.

Hall added “Recruitment for our trial is underway and we hope that in reaching out to those with treatment-resistant depression we can make a difference to their lives as well as developing a medicine for the wider community.”

READ: Medlab Clinical on schedule with medicinal cannabis cancer trial

As well as developing bacteria-based medicines for treating depression, diabetes and chronic kidney disease, Medlab has developed two cannabis-based medicines for oncology patients.

One medicine is used for pain management and the other for seizures, nausea and vomiting, with the first undergoing a clinical trial with seriously ill cancer patients at Royal North Shore Hospital in Sydney.

In the cannabis clinical trial, Medlab’s NanaBis™ will be administered by Medlab’s small particle medicine delivery platform, NanoCelle™.

Medlab also sells Testo Restore, an evidence-based formulation designed to increase free testosterone levels and support muscle strength and recovery.

 

Did you know testosterone levels in men decline from the age of 30?

The aim of #menshealthweek2018 is to encourage men to talk about their health and wellbeing. Speak to a healthcare professional today to see how TestoRestore may help you. #allnatural #evidencebased pic.twitter.com/AaZUgTO0b5

— Medlab Clinical (@medlabclinical) June 14, 2018

 

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Wed, 25 Jul 2018 11:18:00 +1000 https://www.proactiveinvestors.com.au/companies/news/201494/medlab-clinical-begins-recruitment-for-phase-iia-clinical-trial-for-depression-medicine-201494.html
<![CDATA[News - Medlab Clinical on schedule with medicinal cannabis cancer trial ]]> https://www.proactiveinvestors.com.au/companies/news/200313/medlab-clinical-on-schedule-with-medicinal-cannabis-cancer-trial-200313.html Medlab Clinical Ltd (ASX:MDC) is on schedule with recruitment for the clinical trial of its cannabis-based cancer medicine, NanaBis™, at Royal North Shore Hospital in Sydney.

The trial will test the safety, efficacy and dose tolerance in cancer patients with both managed and unmanaged pain.

READ: Medlab Clinical begins trial of cannabis-based cancer pain management medicine

The recruitment update coincides with separate positive feedback received from doctors who have been prescribing the medicine.

Feedback from some doctors is that it is proving effective in decreasing reliance on opioids and in its speed of action, aided by delivery through Medlab’s nano-particle spray, NanoCelle™

Under the Therapeutic Goods Administration’s (TGA) Special Access Scheme, Medlab has approval to supply NanaBis™ to medical practitioners for use with patients suffering cancer pain.

NanaBis™ is one of two developed formulas

Medlab has developed two cannabis-based medicines which have differing cannabis formulations, NanaBis™ and NanaBidial™.

NanaBis™ for those with chronic caner pain which is a whole cannabis plant extract of 1:1 ratios, CBD to THC

NanaBidial™ is for those suffering effects from chemotherapy is similar in all ways to NanaBis™ except the ratio is 18 parts CBD to 1 part THC.

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Mon, 09 Jul 2018 08:38:00 +1000 https://www.proactiveinvestors.com.au/companies/news/200313/medlab-clinical-on-schedule-with-medicinal-cannabis-cancer-trial-200313.html
<![CDATA[News - Medlab Clinical begins trial of cannabis-based cancer pain management medicine ]]> https://www.proactiveinvestors.com.au/companies/news/196965/medlab-clinical-begins-trial-of-cannabis-based-cancer-pain-management-medicine-196965.html Medlab Clinical Ltd (ASX:MDC) has commenced the trial of NanaBis™, its cannabis-based medicine for advanced cancer pain at Royal North Shore Hospital (RNSH) in Sydney.

The trial will test the safety, efficacy and dose tolerance in cancer patients with both managed and unmanaged pain.

Medlab managing director Dr Sean Hall said: “This is what we have been working towards.

“It’s a key milestone for the company, we have a validated GMP Australian manufactured product that is being used in a robust and much-needed trial.”

READ: Medlab Clinical on track for analytical release of Nanabis pain management medicine

Medlab is developing therapies for pain management, depression and obesity, and it is already earning revenue from the sale of nutritional products in Australia and the US.

Dr Hall added: “We are very proud of our research collaboration with both Prof Stephen Clark and the team at RNSH, we are hoping that this trial demonstrates efficacious alternatives to opioid use for this type of patient.”

Preparing for NanaBis drug application

The trial is expected to run over the next few months, with data available later in the year.

Importantly, the trial will form the basis of a NanaBis drug application being put before the Therapeutic Goods Association (TGA) and subsequent global regulatory agencies.

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Tue, 15 May 2018 14:23:00 +1000 https://www.proactiveinvestors.com.au/companies/news/196965/medlab-clinical-begins-trial-of-cannabis-based-cancer-pain-management-medicine-196965.html
<![CDATA[News - Medlab Clinical on track for analytical release of Nanabis pain management medicine ]]> https://www.proactiveinvestors.com.au/companies/news/192477/medlab-clinical-on-track-for-analytical-release-of-nanabis-pain-management-medicine-192477.html Medlab Clinical Ltd (ASX:MDC), a developer of cannabis based medicines, has made solid progress with its proprietary pain management product, Nanabis.

Nanabis is an Australian produced medicine made to Australian standards in an Australian approved facility and the in house developed Nanocelle, is a unique delivery system. 

The medicine will be supported by trial data, giving prescribers confidence in quality and efficacy.

Medlab is developing therapies for pain management, depression and obesity, and it is already earning revenue from the sale of nutritional products in Australia and the US.

Nanocelle is an established delivery system

The Medlab developed nanoparticle medicine delivery system, Nanocelle, is already being applied to its medicines, nutritional products and off-patent drugs like statins.

The first batch of Nanabis product has been manufactured in Melbourne and validated analytical release for supply is expected by March 8, 2018.

Medlab approved as a supplier by Australian government

The Australian Government via the Office of Drug Control, has formally licenced Medlab as a supplier of Nanabis.

In keeping with the Therapeutic Goods Association’s special access scheme, Medlab has instituted medical education seminars to assist health professionals’ understanding.

On validation of the manufactured Nanabis product, Medlab will be in a position to supply a drug that conforms to Australian standards with proven quality and efficacy. 

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Fri, 02 Mar 2018 10:54:00 +1100 https://www.proactiveinvestors.com.au/companies/news/192477/medlab-clinical-on-track-for-analytical-release-of-nanabis-pain-management-medicine-192477.html
<![CDATA[News - Medlab Clinical attracts $24 million for cannabis based medicine ]]> https://www.proactiveinvestors.com.au/companies/news/190663/medlab-clinical-attracts-24-million-for-cannabis-based-medicine-190663.html Medlab Clinical Ltd (ASX:MDC) has successfully completed a placement of shares to institutional and sophisticated investors to raise $24 million at $0.90 per share.

Last year, the company had received approvals to begin human trials of its cannabis based medicine - NanaBis.

NanaBis is packaged as a mouth spray and will be clinically tested in advanced stage cancer patients with intractable pain.

The new funds will help accelerate the commercialisation of NanaBis™. Medlab's NanaBis program is already running 12-18 months ahead of schedule.

The funds will also help Medlab to accelerate its research and development program for other areas in chronic diseases, including obesity, diabetes and depression.

READ: Medlab Clinical wins patent for its unique anti-depression product

In 2017, the company was granted a 20-year patent covering the Australian market for its probiotic product, NRGBiotic™.

NRGBiotic is a probiotic formula which is indicated to support healthy cellular energy production and it has demonstrated significant results for depression sufferers.

According to the World Health Organisation (WHO), 350 million people worldwide suffer from depression.

Medlab’s share price has increased circa 52% over the past one month, last closing at $1.12.

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Fri, 26 Jan 2018 14:07:00 +1100 https://www.proactiveinvestors.com.au/companies/news/190663/medlab-clinical-attracts-24-million-for-cannabis-based-medicine-190663.html
<![CDATA[News - Medlab Clinical wins patent for its unique anti-depression product ]]> https://www.proactiveinvestors.com.au/companies/news/184105/medlab-clinical-wins-patent-for-its-unique-anti-depression-product-184105.html Medlab Clinical Ltd (ASX:MDC) has been granted a 20-year patent covering the Australian market for its probiotic product, NRGBiotic™.

NRGBiotic is a probiotic formula which is indicated to support healthy cellular energy production.

The probiotic species help to support a healthy gut microbial profile and support a healthy immune system.

Interestingly, the current clinical research outcomes for NRGBiotic have provided a novel adjunct option for those with depression.

NRGBiotic has demonstrated a significant enhancement for depression sufferers, thus adding to its commercial potential.

According to the World Health Organisation (WHO), 350 million people worldwide suffer from depression.

In 2015-16, the Australian government spent $564 million, or $24 per person, on subsidised depression prescriptions.

Incidentally, Medlab recently received ethics approvals to proceed with two clinical trials for its cannabis based medicines which are administered using NanoCelle™.

NanoCelle is Medlab’s patented nano-particle spray to the inside of the cheek that quickens absorption of medicine into the bloodstream.

The company’s share price has increased 50% over the past one year, last trading at $0.585.

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Mon, 18 Sep 2017 12:56:00 +1000 https://www.proactiveinvestors.com.au/companies/news/184105/medlab-clinical-wins-patent-for-its-unique-anti-depression-product-184105.html
<![CDATA[News - Medlab Clinical establishes strategic alliance for nutritional products ]]> https://www.proactiveinvestors.com.au/companies/news/180809/medlab-clinical-establishes-strategic-alliance-for-nutritional-products-180809.html Medlab Clinical Ltd (ASX:MDC) has established a strategic alliance with Heritage Brands, to develop over-the-counter well-being solutions for the pharmacy retail channel.

Heritage Brands is an Australian-owned company, which operates in the health, wellness and beauty markets.

This would be an additional sales channel for Medlab which currently markets its specialised nutritional products to doctors, naturopaths and other relevant practitioners in Asia, New Zealand and Australia.

The company recently received ethics approvals to proceed with two clinical trials for its cannabis based medicines which are administered using NanoCelle™.

NanoCelle is Medlab’s patented nano-particle spray to the inside of the cheek that quickens absorption of medicine into the bloodstream.

The partnership with Heritage Brands is intended to increase sales to health conscience consumers.

This relationship is expected to take Heritage Brands into the growing nutraceutical space and strengthen the company’s presence in the wellness sector.

Medlab has already developed 24 evidence-based nutritional products, with eight new products in the pipeline.

The company’s share price has almost doubled during the past one year, last trading at $0.80.

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Thu, 13 Jul 2017 15:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/180809/medlab-clinical-establishes-strategic-alliance-for-nutritional-products-180809.html
<![CDATA[News - Medlab Clinical to begin trials of cannabis based medicines ]]> https://www.proactiveinvestors.com.au/companies/news/179427/medlab-clinical-to-begin-trials-of-cannabis-based-medicines-179427.html Medlab Clinical (ASX:MDC) has received approvals to begin human trials of two different cannabis based medicines – NanaBis and NanaBidial.

NanaBis is packaged as a mouth spray and will be clinically tested in advanced stage cancer patients with intractable pain.

The drug is expected to meet a global need for better pain management, with research having shown cancer pain was an increasingly widespread condition.

Recent statistics regarding cancer pain indicate it is prevalent in 64% of patients with metastatic or advanced-stage disease and that for one in two patients with cancer, it is undertreated.

With the recent U.S. crackdown on opioid abuse, there is a significant need for better, efficacious treatment.

NanaBidial comprises cannabidiol derived from marijuana and is indicated for chemotherapy induced nausea and vomiting, with a secondary endpoint in patients suffering seizures.

The drug is intended to be made available to general practitioners so it would give many Australians access to a drug which governments around the country have been keen to see introduced.

Both clinical trials have received Human Research Ethics Committee (HREC) approvals and are expected to commence shortly.

Recent research on the legal cannabis industry in North America showed consumers spent US$6.9 billion on legal cannabis products in 2016, up 34% from 2015.

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Mon, 19 Jun 2017 12:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/179427/medlab-clinical-to-begin-trials-of-cannabis-based-medicines-179427.html
<![CDATA[News - Medlab Clinical initiates study of cholesterol lowering oral spray ]]> https://www.proactiveinvestors.com.au/companies/news/174257/medlab-clinical-initiates-study-of-cholesterol-lowering-oral-spray-174257.html Medlab Clinical (ASX:MDC) has signed an agreement to initiate a study to compare how its atorvastatin oral spray compares with statin tablets, like Lipitor, the off-patent market leader.

Statins are a class of drugs often prescribed by doctors to help lower cholesterol levels in the blood. By lowering the levels, they help prevent heart attacks and stroke.

The size of the statin market worldwide, predominantly comprised of tablets, is significant and has been estimated at US$12 billion in 2018.

Medlab’s research to date indicates that a more direct oral spray will enable smaller doses and by reducing dosage, remove much of the statin side effects, reported by about one-third of patients.

The testing of Medlab’s atorvastatin oral spray has been promising, but an independent study is expected to provide objective evidence for those pharma companies which have shown interest.

Medlab’s study agreement is with Zenith Technology Corporation of Dunedin New Zealand, a certified research organisation which does clinical trials and analysis.

Incidentally, Medlab is also completing the final steps to start Australia’s first clinical trial using cannabis for oncology patients suffering intractable pain.

The company’s efforts have been supported by the federal government’s recent announcement to facilitate faster supply of medicinal cannabis products.

Medlab recently obtained clearances from Australian health departments and is awaiting a final shipment clearance from Canadian health authorities to import cannabis material from Canada.

The company’s share price has more than doubled during the past six months, last trading at $0.84.

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Mon, 06 Mar 2017 13:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/174257/medlab-clinical-initiates-study-of-cholesterol-lowering-oral-spray-174257.html
<![CDATA[News - Medlab Clinical to start Australia’s first trial of cannabis for oncology patients ]]> https://www.proactiveinvestors.com.au/companies/news/173507/medlab-clinical-to-start-australias-first-trial-of-cannabis-for-oncology-patients-173507.html Medlab Clinical (ASX:MDC) is completing the final steps to start Australia’s first clinical trial using cannabis for oncology patients suffering intractable pain.

The company’s efforts have been supported by the federal government’s recent announcement to facilitate faster supply of medicinal cannabis products.

Medlab recently obtained clearances from Australian health departments and is awaiting a final shipment clearance from Canadian health authorities to import cannabis material from Canada.

The cannabis material is a combination of the two most active cannabis ingredients, formulated by Medlab and being supplied by Canadian licenced producer of medical marijuana, Aphria Inc.

Medlab has arranged the delivery of the cannabis material to a contractor in Melbourne, licenced for controlled substance manufacture.

The cannabis material will be incorporated with Medlab’s small particle medicine delivery system, Nanocelle™, to be readied for the trial.

In conjunction with the manufacturer, Medlab has established a drug manufacturing method that will be the prescribed template for future production.

Prerequisites for trial commencement are ethics approval from Royal North Shore Hospital, which is progressing well, and the issue of a clinical trial number from Therapeutic Goods Administration.

Importantly, the supportive government attitude towards cannabis is encouraging for the future prospects of Medlab’s initiative with cannabis.

The company’s share price has more than doubled during the past six months, last trading at $0.755.

Medlab  is well funded with a cash balance of $4.3 million as at 31 December 2016.

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Wed, 22 Feb 2017 13:00:00 +1100 https://www.proactiveinvestors.com.au/companies/news/173507/medlab-clinical-to-start-australias-first-trial-of-cannabis-for-oncology-patients-173507.html
<![CDATA[News - Medlab Clinical Ltd initiates Phase 2a after positive anti-depression results ]]> https://www.proactiveinvestors.com.au/companies/news/165626/medlab-clinical-ltd-initiates-phase-2a-after-positive-anti-depression-results-70734.html Medlab Clinical Ltd (ASX:MDC) will initiate Phase 2a human trial of its anti-depression therapy following encouraging results from Phase 1. 

Participants in the Phase 1 human trials were administered a Medlab formulation named NRGBiotic to assess whether it could improve depression symptoms and clinical outcomes. 

The first trial of eight weeks showed significant improvement in 80% of the trial cohort, with the second trial of the same period showing further improvement in +90% of the trial cohort.

Medlab is proceeding immediately to Phase 2a human clinical studies on the basis of these significant results.

In initiating the Phase I trial, Medlab hypothesised that treatment-resistant depression may be due to a combination of altered neurophysiological and poor gut health issues. 

The hypothesis has been influenced by the Human Microbiome Project, a five year project by the U.S. National Institute of Health aimed at understanding the role of bacteria living in and on humans. 

Medlab has formulated NRGBiotic as a bacteria-based medicine that targets the gut–brain axis to treat patients diagnosed with treatment-resistant depression. 

Importantly, the outcomes from the Phase I trial were positive for the underlying hypothesis and the application of NRGBiotic. 

The Australian Bureau of Statistics has estimated 45% of Australians aged 16-85 years have met the criteria for a diagnosis of a mental disorder at some point in their lives. 

Medlab is looking to participate in Australia’s mental illness market which costs the country in the order of $20 billion annually.

The company’s share price has increased by 80% during the past 6 months, trading at $0.375.


Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 30 Aug 2016 11:30:00 +1000 https://www.proactiveinvestors.com.au/companies/news/165626/medlab-clinical-ltd-initiates-phase-2a-after-positive-anti-depression-results-70734.html
<![CDATA[News - Medlab Clinical seeks up to $9M through IPO ]]> https://www.proactiveinvestors.com.au/companies/news/138657/medlab-clinical-seeks-up-to-9m-through-ipo--63117.html Medlab Clinical Limited is seeking up to $9 million through an initial public offering to develop its existing nutraceuticals business and carry out further research and development of new nutraceutical products.

The company is offering a minimum of 30 million shares to raise a minimum of $6 million and a maximum of 45 million shares to raise $9 million.

Adding interest, the company is backed by the Hall family, which has successfully built and then sold four nutraceutical companies over the last 30 years.

This included the 2012 sale of FIT-BioCeuticals Limited to Blackmores Limited for approximately $40 million.

The company has an extensive patent portfolio. In addition to the 10 provisional patents lodged, there are a further 5 more in draft

This is anticipated to grow significantly as further products are developed and launched.

Medlab develops nutritional pharmaceutical with an initial focus on probiotics.

These products take advantage of the growing scientific evidence of the links between certain bacteria and gastrointestinal health.

Its initial five products seek to improve gut health, energy levels and protein absorption.

Similar to the BioCeuticals business, Medlab’s products are being marketed to registered practitioners. The current global market for probiotics is estimated to be US$30 billion and is expected to grow to US$45 billion by 2018.   

In addition, Medlab’s research and development program has targeted the development of bacteria-based medicines in five specific areas:

- Anti-ageing;
- Chronic kidney disease;
- Depression;
- Obesity; and
- Pain management.

Human trials for products to alleviate obesity and depression commenced in February 2015. The trials for pain management using medicinal cannabis are awaiting supply approval from the NSW Government.

The company has also established a licensed biologics facility in Sydney as well as sales offices in Australia and the U.S.

Medlab is expected to list as MDC.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 25 Jun 2015 11:00:00 +1000 https://www.proactiveinvestors.com.au/companies/news/138657/medlab-clinical-seeks-up-to-9m-through-ipo--63117.html