Proactiveinvestors United Kingdom Medlab Clinical Ltd https://www.proactiveinvestors.co.uk Proactiveinvestors United Kingdom Medlab Clinical Ltd RSS feed en Sun, 26 May 2019 12:57:36 +0100 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[Media files - Medlab Clinical forges ahead in new vitamin trials for chronic illnesses ]]> https://www.proactiveinvestors.co.uk/companies/stocktube/13250/medlab-clinical-forges-ahead-in-new-vitamin-trials-for-chronic-illnesses-13250.html Tue, 07 May 2019 23:30:00 +0100 https://www.proactiveinvestors.co.uk/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.co.uk/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 +0100 https://www.proactiveinvestors.co.uk/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.co.uk/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 +0000 https://www.proactiveinvestors.co.uk/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.co.uk/companies/stocktube/12556/medlab-clinical-chief-updates-on-progress-with-nanabis-and-nrg-biotic-12556.html Tue, 12 Mar 2019 14:03:00 +0000 https://www.proactiveinvestors.co.uk/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.co.uk/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 +0000 https://www.proactiveinvestors.co.uk/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.co.uk/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 +0000 https://www.proactiveinvestors.co.uk/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.co.uk/companies/stocktube/12132/medlab-clinical-accelerating-vms-business-in-australia-and-nanabis-globally-12132.html Thu, 07 Feb 2019 15:16:00 +0000 https://www.proactiveinvestors.co.uk/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.co.uk/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 +0000 https://www.proactiveinvestors.co.uk/companies/news/213564/medlab-clinical-signs-deal-to-launch-its-nutraceuticals-in-priceline-pharmacy-213564.html
<![CDATA[News - Medlab Clinical eyes cost savings following receipt of SME status in Europe ]]> https://www.proactiveinvestors.co.uk/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 +0000 https://www.proactiveinvestors.co.uk/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.co.uk/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 +0000 https://www.proactiveinvestors.co.uk/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.co.uk/companies/stocktube/11604/medlab-clinical-plans-european-product-expansion-with-wholly-owned-subsidiary-11604.html Wed, 12 Dec 2018 23:38:00 +0000 https://www.proactiveinvestors.co.uk/companies/stocktube/11604/medlab-clinical-plans-european-product-expansion-with-wholly-owned-subsidiary-11604.html <![CDATA[News - Medlab Clinical expanding cannabis-based medicines into Europe ]]> https://www.proactiveinvestors.co.uk/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 +0000 https://www.proactiveinvestors.co.uk/companies/news/210430/medlab-clinical-expanding-cannabis-based-medicines-into-europe-210430.html
<![CDATA[Media files - Medlab's Hall: "Time to offer something new" to challenge reliance on opioids ]]> https://www.proactiveinvestors.co.uk/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 +0100 https://www.proactiveinvestors.co.uk/companies/stocktube/10616/medlab-s-hall-time-to-offer-something-new-to-challenge-reliance-on-opioids-10616.html <![CDATA[News - Medlab Clinical Ltd initiates Phase 2a after positive anti-depression results ]]> https://www.proactiveinvestors.co.uk/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 +0100 https://www.proactiveinvestors.co.uk/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.co.uk/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 +0100 https://www.proactiveinvestors.co.uk/companies/news/138657/medlab-clinical-seeks-up-to-9m-through-ipo--63117.html