- MGC Pharmaceuticals (MXC) has received ethics approval to begin a phase 2b clinical trial for its CannEpil product
- CannEpil is a low cannabidiol (CBD), high tetrahydrocannabinol (THC) formula that is used to treat epilepsy
- The trial will be conducted at the Schneider Children’s Medical Center of Israel
- A total of 103 patients aged between one and 18 will take part in the trial to determine the safety and efficacy of the product
- The trial is expected to begin in September following final approvals from the Ministry of Health in Israel
- MGC Pharma is steady on the market today and shares have been trading for 2.5 cents each since May 18
MGC Pharmaceuticals (MXC) has received ethics approval to begin a phase 2b clinical trial for its CannEpil product.
The company received approval from Schneider Children’s Medical Center of Israel and the trial will be completed at the centre.
The trial will be randomised, double-blind, and placebo-controlled to determine the safety and efficacy of CannEpil in children and adolescents with refractory epilepsy.
Refractory epilepsy, also known as drug-resistant epilepsy, is the name given when medication isn’t bringing the seizures under control.
A total of 103 patients aged between one and 18 years old will take part in the trial.
The trial will last for 12 weeks per patient and is expected to begin in September 2020 following the receipt of final approvals from the Ministry of Health in Israel, which are expected in August.
Following these approvals, recruitment can begin.
The trial will be supervised by the lead of MGC Pharma’s neurological development team, Professor Uri Kramer.
Professor Uri is recognised as a global expert in paediatric epilepsy and he has previously led research regarding medicinal cannabis as a treatment for severe cases of epilepsy.
He also has a wealth of experience in neurology, paediatric neurology, and child development.
“Receiving ethics approval for the phase IIb clinical trial of CannEpil is another important milestone for the company,” Co-Founder and Managing Director Roby Zomer commented.
“CannEpil is one of the company’s lead cannabinoid medicine products with a very significant global market opportunity,” he said.
“Israel is recognised for its leading researchers and institutions in relation to cannabis products and we look forward to updating the market as this trial progresses,” he added.
Results from the trial will provide essential data in regards to characterising the medicinal value of CannEpil and outline the next steps to take to gain market authorisation.
MGC Pharma is steady on the market today and shares have been trading for 2.5 cents each since May 18.