MMJ-002 / MMJ International - LARVOL DELTA

MMJ International Follows FDA Guidance in Marijuana Medicine Development As FDA Recalls Dozens of CBD Products For Lead Contamination (Yahoo Finance) - “MMJ-002 is being developed to treat Huntington's-associated chorea (involuntary jerking or writhing movements)…. MMJ International Holdings continues to separate itself from the pack as the Food and Drug Administration (FDA) is publicizing a voluntary recall of dozens of human CBD products after the Florida Department of Health notified a company of lead contamination.”

Commercial • CNS Disorders • Huntington's Disease

DEA clears way for MMJ to Import cannabis compounds for trials in Huntington’s Disease and MS (Huntington’s Disease News) - "The U.S. Drug Enforcement Administration (DEA) cleared MMJ to import the compounds from Canada, after the company made the request three months ago....MMJ-001 and MMJ-002 are two of MMJ’s lead therapeutic candidates, and are liquid formulations of highly purified THC and CBD. The company is developing MMJ-001 to treat spasticity (abnormal muscle tightness) in MS, and MMJ-002 to treat Huntington’s-associated chorea — a neurological condition marked by involuntary spasms or writhing movements."

Commercial

MMJ BioPharma cultivation in line for DEA license to grow cannabis (Yahoo Finance) - “MMJ BioPharma Cultivation…today announced that it has signed a memorandum of understanding (MOU) with MMJ International Holdings to grow cannabis and supply active pharmaceutical ingredients (API) for its drug product MMJ-001 and MMJ-002. MMJ BioPharma Cultivation will be supplying MMJIH with extracts from the marijuana plant to support its investigational new drug (IND) filings with the FDA for Multiple Sclerosis and Huntington's disease.”

Licensing / partnership

MMJ International Holdings following FDA guidance in cannabis drug development process (Yahoo Finance) - “MMJ International Holdings, the premier medical cannabis research company, recently announced that the FDA has made an award for 'Orphan Drug Designation' for its THC and CBD proprietary drug formulation which will be used for the treatment of Huntington's Disease. The drug, MMJ-002 is one of MMJ's lead drugs and the company is confident that it will bring much needed relief to patients suffering from the debilitating effects of Huntington's Disease”

Clinical

MMJ International holdings announces MOU for manufacturing of THC-CBD derived drugs (Yahoo Finance) - “MMJ International Holdings has announced an agreement for manufacturing of its oral drug product for the treatment of multiple sclerosis (MS) and Huntington's disease (HD) with Thermo Fisher Scientific.”

Commercial

Cannabinoid-based treatment for Huntington’s granted Orphan Drug designation by FDA (Huntington’s Disease News) - "MMJ-002, a cannabis investigational product for the treatment of Huntington’s disease, has been granted Orphan Drug designation by the U.S. Food and Drug Administration,...'MMJ’s scheduled Phase 2 clinical trial for this program will demonstrate the ability of this therapy to slow or stop the deleterious effects of Huntington’s chorea'..."

New P2 trial • Orphan drug

FDA asked to place cannabis-based therapy for progressive MS on fast track, MMJ Holdings says (Multiple Sclerosis News Today) - “‘MMJ has also requested FDA approval to test its cannabis-based candidate in Huntington’s patients, announcing in August the filing of an Investigational New Drug (IND) application to begin clinical testing. MMJ-002, as its cannabis-based candidate for Huntington’s is known, was recently designed an orphan drug by the FDA and a Phase 2 clinical trial in Huntington’s patients is 'scheduled,' the company said in a Feb. 13 release.’”

IND • New P2 trial

Newly added product (Multiple Sclerosis News Today) - Preclinical, Huntington's Disease

Pipeline update