ST. PETERSBURG, Fla.,
April 8, 2020 /PRNewswire-PRWeb/
-- 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."
Contact:
Michael Sharp
561-627-9455
SOURCE: MMJ International Holdings
SOURCE MMJ International Holdings