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Medlab Clinical Ltd: DEEP DIVE
OVERVIEW

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

A phase I study in Australia is evaluating a cannabis spray therapeutic in cancer patients.
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Patients are being studied at clinical trial sites in Sydney

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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