MGC Pharmaceuticals, which is building a medical cannabis business, is commencing a six-week medical cannabis clinical study following the signing of an agreement with the University Children’s Hospital Ljubljana in Slovenia.
The Phase IIA Crossover (non-pivotal) clinical study will use enriched medical cannabis products in children and adolescents with treatment-resistant epilepsy at the Hospital’s Department of Adolescent and Developmental Neurology.
The study hopes to identify a reduction in the frequency of seizures experienced by individuals suffering from epilepsy.
Over 65 patients have already been recruited to participate in the 6-week study, with a total of 70 volunteers required to achieve statistical significance. The company has a large pool of over 150 potential volunteers who have expressed an interest in participating.
The study brings together two globally renowned epilepsy experts, Dr David Neubaeur and MGC advisory board member Professor Uri Kramer, to oversee the clinical test program.
Following the clinical efficacy study, the company aims to have the formula designated as a magisterial drug in Slovenia which allows Slovenian doctors to prescribe the product to sufferers of epilepsy.
MGC Pharmaceuticals said it also intends to register the product as a medical product for sale across the European Union and other geographies, following the required legal and regulatory approvals.
“We look forward to the results of our clinical study on the efficacy of our medical cannabis formulation for the treatment of epilepsy in young people. We are confident that medical cannabis has the potential to bring relief to many people across the globe currently suffering with epilepsy. Additionally, the development of a cannabis-based product targeted at the relief of epilepsy presents a significant commercial opportunity for MGC Pharmaceuticals," said Nativ Segev, MGC Pharmaceuticals co-founder and managing director.