ST. PETERSBURG, FL / ACCESSWIRE / April 29, 2020 / MMJ International Holdings, the premier medical cannabis research company, announced that it has received conditional approval from the Institutional Review Board for its FDA Huntington’s Disease study.
What is an IRB and why is this significant?
Under FDA regulations, an IRB is an independent group of professionals that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve required protocols and monitor the clinical trial to protect the rights and welfare of human subjects involved in research activities being conducted by MMJ.
MMJ’s CEO, Duane Boise stated, ″MMJ’s IRB conditional approval is a significant accomplishment as it establishes credibility to MMJ’s scientific approach to marijuana drug development. We continue to set industry standards by following FDA and DEA guidance in our development of plant-derived cannabinoid therapeutics.”
Dr. Elio Mariani, MMJ International Holdings director of drug development and experienced pharmaceutical veteran stated that “We firmly believe that our MMJ natural whole plant derived molecules with a unique combination of pharmacological properties will be FDA approved as a safe and effective prescription drug that can be of great benefit in treating patients with MS and HD diseases,”
MMJ International Holdings has several academic institutions preparing to study cannabis in Multiple Sclerosis and Huntington’s disease. The MMJ clinical trials will provide the necessary data to the FDA to prove that cannabis can treat essential tremors, a neurological disorder that causes involuntary shaking.
Eager to initiate its FDA clinical trials, MMJ International Holdings recently made history by being the first cannabis company to import highly concentrated medical marijuana extracts into the United States for clinical trial use. Health Canada and the US Drug Enforcement Agency approved MMJ to ship the compounds for its clinical trials.
For continued quality supply of its marijuana plant products, MMJ International Holdings has negotiated a deal with MMJ BioPharma Cultivation,Inc who has applied for the much coveted DEA federal marijuana growers license. Under the terms of the deal, MMJ BioPharma Cultivation will be supplying pharmaceutical grade marijuana for MMJ International Holdings for its future pharmaceutical drug development needs.
Tim Moynahan the company’s chair stated “We are pleased with the DEA ‘s cooperation and support to facilitate our company’s scientific mission to develop these medications to provide relief to patients suffering from these chronic diseases.”
Contact:
Michael Sharp
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SOURCE: MMJ International Holdings
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