The drug development company says it has reached another milestone in its efforts to facilitate much needed cannabis clinical trials.
ST. PETERSBURG, FL / ACCESSWIRE / April 7, 2020 / Ever eager to facilitate its drug development and FDA clinical trials, MMJ International Holdings will make history by being what it claims is the first cannabis company to import highly concentrated medical marijuana extracts into the United States for clinical trial use.
The US-based company said Tuesday that it has facilitated the shipment to a specialty pharmaceutical gel cap manufacturing company for further testing and development of its proprietary formulation of MMJ-001 and MMJ-002. MMJ International Holdings is developing an oral drug product from natural whole plant extract derivatives from the marijuana plant containing THC and CBD. MMJ will be utilizing its new product for a FDA approved clinical trials in multiple sclerosis (MS) and Huntington's disease (HD). The US Drug Enforcement Agency's approved MMJ to ship the compounds for its clinical trials.
Most recently 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 future pharmaceutical drug development needs. Once the medication is approved by the FDA it will be sold in pharmacies.
MMJ International Holdings also has been awarded the FDA Orphan Drug award which means that MMJ has demonstrated its promise for the diagnosis and or treatment of rare diseases or conditions. Orphan designation qualifies MMJ International Holdings for various development incentives provided by the Orphan Drug Award, including tax credits for qualified clinical testing.
As stated by MMJ's CEO, Duane Boise, ″MMJ's DEA approval and FDA Orphan Drug award are milestone that the company has meet as we continue to set industry standards. MMJ has established a leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, intellectual property portfolio and regulatory and manufacturing expertise″.
Dr. Elio Mariani, MMJ's director of drug development stated that "MMJ International Holdings continues its process of scientific drug development and discovery by FDA protocol development processes, intellectual property portfolio and DEA regulatory manufacturing guidelines". "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."
Tim Moynahan the company chairman stated that "Patients in the MMJ International holdings clinical trials will receive gelatin capsules containing THC and CBD daily. MMJ International Holdings has several academic institutions preparing to study cannabis in Multiple Sclerosis and Huntington's disease." MMJ clinical trials will provide the necessary data to prove that cannabis can treat essential tremors, a neurological disorder that causes involuntary shaking. Tim Moynahan further stated that "Ultimately, there's so much interest in THC and CBD as a treatment modality, so MMJ will be providing the clinical research data necessary to prove patient dosing, safety, and efficacy."
In conclusion Duane Boise stated, "We are pleased with the DEA 's cooperation and support to facilitate our company mission to service the unmet needs of patients suffering from these chronic diseases."
SOURCE: MMJ International Holdings
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