MMJ’s phase 2 clinical trial shows CBD impact on epilepsy

MMJ ASX phase 2 clinical trial CBD impact epilepsy cannabis PhytoTech Therapeutics
Satipharm’s CBD capsules significantly reduced monthly seizure frequency in the treatment resistant children when added to current medications.

Biotech and global cannabis investment company MMJ (ASX: MMJ) has published results from its phase 2 clinical trial, completed through its subsidiary PhytoTech Therapeutics.

MMJ’s study indicates as many as 82% of patients noticed a reduction in seizures while 73% were confirmed as “very much improved”, which bodes well for future CBD-based treatments.

PhytoTech is in the process of being sold to Harvest One Cannabis (TSX-V: HVT), a Canadian company later this year, with today’s results further helping to corroborate the growing view that cannabinoid treatments have a significant part to play in treating various physical and neurological conditions.

MMJ CEO Jason Conroy told Small Caps that subject to ASX approval, the transaction is expected to be completed by the end of September 2018. Harvest One Cannabis is looking to expand its cannabis production capacity capability from 2,000kg per year to 8,000kg per year.

MMJ says that its trial was an open-label, single-centre clinical study to evaluate the safety, tolerability and efficacy of oral administration of the Satipharm CBD capsules as a treatment for refractory and treatment-resistant epilepsy amongst children.

According to the study, 16 patients were screened and started the cannabinoid (CBD) treatment with 11 patients completing the study and setting a patience adherence rate of 96%.

Study details

Over a set of three designated periods, the trial included observation, dosage and treatment as well as a follow-up phase lasting 2 weeks.

Patients were eligible to participate if they were between 2 and 15 years old and had failed to respond to existing treatment including four variants of anti-epileptic drugs (AEDs) that failed to regulate seizure control.

The key findings of the trial showed that Satipharm CBD capsules demonstrated “promising evidence of efficacy” and significantly reduced monthly seizure frequency in the treatment-resistant children when added to current medications. The median reduction rate was 82% in the 12-week treatment period compared to the 4-week observation period prior.

According to MMJ, 73% of patients included in the study were rated as “very much improved/improved” in overall condition on the ‘Caregiver Global Impression of Improvement’ scale and 82% of patients were classified as “very much reduced/reduced”.

“Notwithstanding the small number of patients treated, the efficacy of Satipharm’s CBD capsules as add-on therapy in the treatment of paediatric, intractable epilepsy has been shown,” said Prof Uri Kramer, Director of Pediatric Epilepsy Service at Tel Aviv Sourasky Medical Center and principal investigator of the clinical study.

“Moreover, these results compare favourably to other similar studies of cannabidiol, including those published by GW Pharmaceuticals. Importantly, the significant reductions in seizure frequency while demonstrating satisfactory safety and tolerability profile, in these very difficult to treat patients, have the potential to be a life-altering event for these patients and their families.”

“I would be greatly interested in prescribing such standardized and clinically tested product as Satipharm’s CBD,” added Dr Kramer.

MMJ milestones in the months to come

MMJ’s activities over the coming 6 months could potentially add further price sensitive news flow.

Mr Conroy explained to Small Caps that MediPharm Labs was aiming to list on the Canadian stock exchange (TSX-V) with a reverse takeover in September.

Elsewhere amongst its portfolio, Weed Me expects to receive its sales licence from Health Canada in Q4/2018.

Furthermore, Cannabis Access launched “Cannabis Access Clinics” this week. Mr Conroy said that two clinics were planned so far in Sydney and Melbourne, with “more to come by the end of the year”.

Also likely to be listed in the coming months is Fire & Flower, a corporate retail store, specialising in elevating Canadian cannabis products) – yet another portfolio asset that MMK expects to list on the TSX-V in the next few months.

Bien, an intellectual property, branding and licensing company has also signed a deal with MMJ with first sales of its licensed powdered CBD and THC products expected to commence in California in September.

According to MMJ, Martha Jane Medical, a cannabis research entity, is targeting an IPO on the ASX at the end of the year.

BevCanna, a “cannabis infused” beverage manufacturer is preparing to build its manufacturing infrastructure subject to further funding rounds with sales expected to start trickling in “late next year” with Health Canada setting the rules for edibles and beverages in Canada.