MMJ oral pill passes Phase 1 Clinical Trials

MMJ Phytotech (ASX:MMJ) has taken its first steps towards its end-goal of filing a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in order to grow and supply medicinal cannabis. MMJ is the first medical grade cannabis company to be listed on the ASX, operating a ‘farm to pharma’ strategy that could see the company bloom into a pharmaceutical company with full supply chain integration.

Looming changes in national legislation within Australia are likely make growing and selling medical cannabis less restrictive therefore paving the way for MMJ to commence selling medical cannabis products as soon as legislation allows.

As part of a regulatory filing with the ASX, MMJ reports that its trials “indicate that MMJ’s formulations are the same or even higher performance level when compared to GW Pharmaceutical’s product”.

The trial involved administering dosages of medicinal cannabis to 15 healthy volunteers of two oral THC:CBD formulations in comparison to Sativex, the leading oromucosal medicinal cannabis spray from GW Pharmaceuticals.

A Phase 1 clinical trial of MMJ’s oral capsules was undertaken at the Souravsky Medical Clinical Research Center in Israel, through a “single-centre, multi-arm, randomised, crossover study” assessing the safety, tolerability and pharmacokinetics of MMJ’s product.

The results in detail

The results of MMJ’s Phase 1 Trials are extremely positive with consistent results among all 14 test subjects that completed the trial.

The Trial yielded the following results:

• Demonstrable safety and tolerability profile with no significant side effects;
• Higher bioavailability of active compounds in comparison to GW Pharmaceuticals oromucosal spray – Sativex;
• Very rapid onset; and
• 8 hours exposure time in the blood

A comparison of plasma concentration over time between MMJ’s CBD/THC capsule and GW’s nasal spray indicates that MMJ’s capsules have a quicker uptake time and longer-lasting effects within the patient.

Having succeeded at Phase 1, MMJ now plans to move onto Phase 2 “in the second half of 2016”. Phase 2 will assess the efficacy of oral capsules in treating pain and spasticity amongst multiple sclerosis sufferers, with results expected in 2017.

Sourasky Medical Center in Tel-Aviv

MMJ has also announced an extension of its license agreement with Yissum, the commercial arm of Hebrew University of Jerusalem. According to an ASX announcement, MMJ’s extension of the exclusive licensing agreement with Yissum will “include the addition of two new US provisional patent applications” thereby improving MMJ’s IP Portfolio.

The first additional patent comprises active combinations of THC and CBD in a dispersible concentrate. The second patent comprises dry, rapid water dispersible nano-particles containing cannabinoids incorporated into a biodegradable polymer. MMJ says this patent’s “unique formulation offers high yield, extended release, high bio-availability and water solubility cannabinoids”, that “can be delivered in oral, inject-able, topical, inhaled and ear/eye drop formulations”.

MMJ Growing in Canada

ASX-listed MMJ has growing operations currently undergoing regulatory checks with a full growing license expected to be awarded within weeks.

The Duncan facility close to Vancouver, Canada will produce an estimated 1000kg of high grade medicinal cannabis per year, once fully up and running.

While MMJ progresses its growing operations under Canadian subsidiary United Greeneries, its Israel-based unit, Phytotech Theraputics is progressing with clinical trials of MMJ’s CBD-based oral capsule, designed for treating multiple sclerosis.