MGC Pharmaceuticals has received Human Research Ethics Committee approval to conduct a head-to-head clinical study to compare the effectiveness of its low tetrahydrocannabinol formula for the treatment of drug-resistant epilepsy to its 100% cannabidiol product.
The low tetrahydrocannabinol product is a proprietary pharmaceutical-grade phytocannabinoid-derived medicine authorised for prescription as an Investigational Medicinal Product in Australia and the UK, while the 100% cannabidiol product is currently available under Australia’s Special Access Scheme.
Management said the study, which will be carried out together with Cannabis Access Clinics and Epilepsy Action Australia, will be one of the first clinical opportunities in the world to assess and collect several data points.
These data points include the long-term safety of tetrahydrocannabinol treatments, the efficacy of cannabinoid treatments compared to currently available treatments and doctors’ assessments on cannabinoid medicine’s long-term impact on the quality of treatment and quality of life.
MGC said the study would be carried out on 100 patients from Cannabis Access Clinics for 12 months.
Managing Director Roby Zomer said the study will potentially demonstrate the increased efficacy of its low tetrahydrocannabinol product for the treatment of severe epilepsy and highlight the company’s commitment to being at the forefront of research and innovation in the sector.
“As such, we are delighted to have received approval from the HREC which enables us to immediately start the study connecting patients in need with MGC Pharma’s products and providing valuable information and data on the effectiveness of phytocannabinoid based treatments and epilepsy,” he added.
Epilepsy Action Australia Chief Executive Officer Carol Ireland said: “Epilepsy Action Australia is always happy to see more research being conducted on the benefits of cannabis treatments for epilepsy, as continued positive results will assist in ensuring it becomes mainstream.”
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