Ethics body approves another clinical trial using MGC Pharma’s epilepsy drug
Health & Biotech
Health & Biotech
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Special Report: MGC Pharma’s flagship epilepsy drug CannEpil will be the subject of yet another clinical trial after Australia’s ethics body approved a new study.
MGC (ASX:MXC) will conduct a head-to-head clinical study on severe intractable epilepsy in collaboration with Cannabis Access Clinics and Epilepsy Action Australia, a direct comparison assessing the efficacy of low-THC to 100 per cent CBD products when treating severe intractable epilepsy.
It comes barely a week after the Human Research Ethics Committee (HREC) — which must sign off on all clinical trials before they can proceed — granted the company approval to test the effects of CannEpil on driver performance.
This new study will consist of 100 epilepsy patients treated with either CannEpil or MXP100, MGC’s CBD-only formula containing 100mg/mL of CBD, with difference in efficacy analysed.
It will be one of the first clinical opportunities in the world to assess and collect several data points including long term safety of THC, efficacy of cannabinoid treatments against current available treatments, and, crucially, the medical community education process and doctor assessments’ on cannabinoid medicine’s long-term impact on quality of treatment and quality of life.
Epilepsy Action Australia has formally endorsed the trial and will provide assistance with patient recruitment.
Roby Zomer, co-founder and MD of MGC, said the trials were part of his company’s commitment to being at the forefront of research and innovation in the sector, leading to increased patient access.
“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 said.
Dr Sanjay Nijahawan, Medical Director Cannabis Access Clinics, added: “We see a lot of epilepsy patients in our clinics and we hope that studies like this will help doctors understand more about the clinical benefits of medicinal cannabis and best to prescribe it for their patients.”