New Cannabis-based Experimental Drugs could go into Clinical Trials for Huntington’s Disease and MS

Jan 18, 2020 | Cannabinoid, Cannabis, CBD, FDA

New Cannabis-based Experimental Drugs could go into Clinical Trials for Huntington’s Disease and MS

MMJ International Holdings (MMJ), an entrepreneurial cannabis-based research and development venture with operations in the United States and Jamaica recently shared government hearings and what the venture’s principals hope, is a movement to loosen up cannabis laws to encourage medical research. MMJ stands to gain, should that happen. as they seek to initiate clinical trials in Multiple Sclerosis (MS) and Huntington’s Disease (HD) to prove safety and efficacy for patients. But they will need money first, and the cannabis investment climate of late is cold. Possibly helping their cause, according to their press, they have accomplished a number of important milestones—including DEA’s most recent approval for its THC and CBD international shipment to the US for additional development of its plant-derived cannabinoid drug and an FDA “Orphan Drug Designation” award for its proprietary drug formulation. Could this thinly capitalized, boot-strapped, but focused and differentiated venture, rise to higher heights above the rest of the cannabis medical R&D pack?

Government Agencies Acknowledge Inadequate Supply of Cannabis for Study Purposes

The House Energy and Commerce Subcommittee on Health recently held hearings on cannabis with much of the focus on research, with the Drug Enforcement Administration revealing that it has a cultivation licensing proposal pending before the White House Office of Management and Budget.

Congressional Hearing on C-Span: Regulators Appear to Warm to Cannabis-based Research

MMJ’s recent press release linked to a congressional hearing aired on C-SPAN, highlighting federal regulators recognizing that valuable research into marijuana is needed. MMJ highlights that important research has been inhibited by cannabis’s current legal status. In the C-SPAN-covered hearing, the FDA, DEA, and NIDA described how they are taking steps to resolve the issue.

MMJ-002

MMJ-002 was awarded Orphan Drug Designation status by the FDA for clinical trials for the treatment of Huntington’s Disease. Orphan designation qualifies firms such as MMJ for various development incentives of the Orphan Drug Award, including tax credits for qualified clinical testing. Dr. Elio Mariani heads MMJ’s R&D and noted that MMJ-001 “is a patented molecule derived from cannabidiol (CBD)” under development for both Huntington’s Disease and multiple sclerosis.

MMJ International Holdings

The company was founded in 2015 by an entrepreneur named Duane Boise and maintains offices in both Florida and Jamaica. A small, thinly-capitalized venture, it positions itself as different and distinct from most other cannabis-based companies as it is a “premier medical cannabis research company with a mission to develop FDA-approved, cannabis-based drugs that provide symptomatic relief of spasticity, chorea, and pain as an alternative to both opiates and unstudied medical marijuana products. The company seems to have few people, from a brief review on LinkedIn under 15. It does appear to generate a lot of marketing-centric press releases for attention—which indicates the search for capital, which was acknowledged with the retaining of a boutique financial advisory firm.

Seeking $20 Million Dollars

As the company has received Orphan Status and it would appear that federal rules could at some point go in their favor, the firm retained MFS Capital Advisors to provide financial strategy services, not to mention assist in the capital needs for the company’s FDA approved drug development and clinical trials. In a recent press release, they announced they were in search of $20 million for R&D. Due to the current cannabis federal legal status, it could be more challenging to raise the funding—but on the other hand, with the winds possibly blowing toward the loosening of the law, an investment round could be oversubscribed if the right events unfolded at the right time. But there has been a recent collapse in cannabis-based markets—the Wall Street Journal going so far as to call it “a crash” in October of last year. But on the other hand, if MMJ isn’t a traditional cannabis company—it positions itself as an FDA-based R&D venture—hence if it keeps on its course as one of the few such ventures 100% aligned with FDA rules, guidelines and principles, in the long run, it could be well-positioned assuming its science is solid.

FDA Current Status

The FDA publishes that it understands the growing interest in the possible utility of cannabis for a variety of medical conditions, not to mention research on the possible adverse health effects from the use of cannabis. To date, the FDA has approved no marketing application for cannabis for the treatment of any disease or condition. According to the FDA’s website, they have approved one cannabis-derived drug product called Epidiolex (cannabidiol) and three synthetic cannabis-related drug products, including 1) Marinol (dronabinol), 2) Syndros (dronabinol) and 3) Cesamet (nabilone). Note these drugs are only available with a prescription from a licensed healthcare provider. Importantly, the FDA has not approved any other cannabis-derived or cannabidiol (CBD) products currently on the market.

Epidiolex, consisting of a purified form of the drug substance cannabidiol (CBD), is for treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years or older. Both Marinol and Syndros are approved by the FDA in the US for nausea associated with cancer chemotherapy and for the treatment of anorexia associated with weight loss in AIDS patients. Both Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9-tetrahydrocannabinol (THC), which is considered an intoxicating psychoactive component of cannabis). Cesamet contains the active ingredient nabilone, which has a chemical structure like THC and is synthetically derived. It is used for nausea associated with cancer chemotherapy.

The FDA is committed to encouraging the development of cannabis-related drug products, including CBD. The groups within the FDA that engage with cannabis-based sponsors include the CDER review division and CDER’s Botanical Review Team (BRT).

US Behind in Cannabis Research

Because of its federal laws, the U.S. is not a key player in cannabis-based medical research. Israel is known as a leader world full of cannabis research. In one publication, it ranks the following as the top centers for cannabis-based medical research: 1) Israel, 2) Netherlands, 3) Uruguay 4) the Czech Republic, and 5) Spain.

Source: mmj

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