MGC Pharmaceuticals Ltd (ASX: MXC), a European based bio-pharma, today announced that the company had received ethical approval from Schneider Children's Medical Center of Israel to begin a phase IIb clinical trial for its proprietary epilepsy treatment, CannEpil®.
The Epilepsy Trial will be a randomised, double blind, placebo controlled, Phase IIb study to determine the safety and efficacy of CannEpil® as an adjunct treatment in children that suffer from forms of drug-resistant epilepsies.
103 patients between the ages of 1 and 18 years old will be recruited in the trial, to be led by Principal Investigator Dr. Dror Kraus from the Schneider Hospital in Israel, for a total of 12 weeks per patient.
The Trial is scheduled to begin in September 2020 once MGC has acquired receipt of final approvals from the Ministry of Health in Israel, which are expected to come a month prior. Once approval has been finalized, MGC can begin to recruit patients.
The Trial will be under the supervision of Professor Uri Kramer, the lead of neurological development in MGC Pharma's clinical advisory team. Professor Kramer is a former Director of Paediatric Epilepsy Service at Tel Aviv Sourasky Medical Centre in Tel Aviv, Israel, and has a wealth of experience through his previous research regarding medical cannabis treatments for severe cases of epilepsy.
The trial will help MGC to determine how effective CannEpil is in treating various forms of epilepsy, and will help the company move towards marketing and commercial discussions. Throughout Australia and Europe there is a combined 2.1 million people with epilepsy, with an annual treatment cost of roughly $15,000 per patient.
Until commercialization is achieved, MGC will continue prescribing CannEpil as an IMP, or Investigational Medicinal Product through the company's distribution network of partners.
Receiving ethics committee approval for the Phase IIb clinical trial of CannEpil® is another important milestone for the Company. Roby Zomer, Co-founder and Managing Director of MGC Pharma
Roby Zomer, Co-founder and Managing Director of MGC Pharma, commented: "CannEpil® is one of the Company's lead cannabinoid medicine products with a very significant global market opportunity. Israel is recognised for its world leading researchers and institutions in relation to cannabis products and we look forward to updating the market as this trial progresses."
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