The company has officially launched Phase II clinical trials for its dementia and Alzheimer's drug, following the receipt of its first bulk shipment of CogniCann in December 2019
The European based 'Seed to Medicine' bio-pharma company, MGC Pharmaceuticals (ASX:MXC), announced today that the first patients in its Phase II Clinical Trial in partnership with the University of Notre Dame (UNDA) have officially begun treatment.
The trial is aimed at evaluating the effects of its groundbreaking drug CogniCann on patients suffering from dementia and Alzheimer's symptoms, and will involve a study group of 50 patients aged 65 or older.
The number of dementia patients with various behavioural difficulties is growing globally. We have designed a phytocannabinoid derived medication with a ratio of cannabinoids that we hope to demonstrate is appropriate for treating this unique group. Through this study, we hope that in the near future we can offer patients with dementia an effective medication that will significantly improve their quality of life.MGC Pharma Clinical Advisory Team Member, Professor Uri Kramer
The company is currently recruiting participants for the trial—which is set to run for 18 weeks per patient—from various aged care facilities through Perth, Western Australia.
According to MGC, new patients are expected to commence treatment each week, while results of the trial are expected by the end of Q3 2021.
"We are excited to begin treatment with our first group of participants to assess the clinical efficacy of CogniCann® to improve the quality of life of those living with dementia," UNDA Principal Investigator Dr Amanda Tiller said.
The study will feature a randomised double blind, crossover, placebo-controlled clinical trial and will be aimed at assessing the efficacy of efficacy of CogniCann and determine the optimum therapeutic dose response.
The staged enrolment will mean that the study is expected to run for a period of over 12 months and will include a series of pre and post surveys to assess caregivers and family member's understanding and perception of the treatment.
MGC's clinical trial process was designed by the company's expert Clinical Advisory Team—which is led by Professor Uri Kramer—with assistance from the research team at UNDA.
According to the Co-Founder and Managing Director of MGC Pharma, Roby Zomer, the company is proud "to see the commencement of this Phase II clinical trial in partnership with UNDA."
"The Trial will provide the healthcare community with more evidence on the performance and the benefits of phytocannabinoid-derived medicines, in particular for patients suffering from dementia and Alzheimer's disease, and we hope to see positive results in the near future," Zomer said.
"If successful, CogniCann has the potential to positively impact the lives of patients and their carers around the world, and contribute to a novel avenue of clinical research and development for contending with the challenges of the effects of dementia and Alzheimer's disease."
"We are privileged to work with such an esteemed medical institution as UNDA and its research team, that was rated as at world standard in the "Excellence in Research for Australia" 2018 assessment process. I look forward to updating the market on progress of our Trial."
To learn more about MGC Pharma visit their Company HQ here.
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