Last week the U.S. Drug Enforcement Administration (“DEA”) made an unexpected ruling regarding the ongoing scheduling of cannabis (aka: marijuana). After much deliberation, almost a full year in the waiting, the DEA announced that there will be no change to the current scheduling of marijuana and it remain listed as a schedule 1 controlled substance. The DEA did give guidance that they support continued scientific research on cannabis and its constituents and that any findings that lead towards medicinal value should further be taken through the U.S. Food and Drug Administration (“FDA”) for clinical trials and subsequent approval (see: http://apps.npr.org/documents/document.html?id=3010607-AA-Rosenberg-Marijuana-Petition-Ltr-08-11-2016)
This news from the DEA validates our business model and our efforts from our inception. Since 2010, Kannalife Sciences, Inc. (“Kannalife”) has taken a scientific, “by the book” approach, meeting the strict DEA and FDA criteria to researching and developing our target drug candidates, namely cannabidiol (CBD) and cannabidiol-derived molecules.
We commend the DEA and respect their position as the FDA drug approval process is the most appropriate way to assess whether a product derived from marijuana or its constituents is safe and effective and has an accepted medical use.
Prior to the news from the DEA, Kannalife was featured in July in Sports Illustrated (see: http://www.si.com/nfl/2016/07/12/cannabis-cte-treatment-kannalife). This feature story in Sports Illustrated draws attention to the serious nature of concussive injury and the work Kannalife is doing to find a treatment for the concussion related disease known as Chronic Traumatic Encephalopathy (CTE) which has and continues to plague contact sports athletes, primarily football players.
In addition to the work we are currently doing on CTE, to date, we have completed 90% of our pre-clinical research for an orphan disease known as Hepatic Encephalopathy (HE). In our pharmacokinetic and pharmacodynamic studies we’ve looked to CBD as a positive control and compared it to KLS-13019, our proprietary novel cannabidiol-derived molecule. The results on KLS-13019 have shown that, while CBD has great potential, KLS-13019 has even greater potential to treat late stage neurodegenerative diseases (see: ACS Med. Chem. Lett. 2016, 7 (4) pp 424-428 – http://pubs.acs.org/doi/abs/10.1021/acsmedchemlett.6b00009)
By way of background, Kannalife, founded in 2010, focuses primarily on the research, development and commercial use of cannabinoid therapeutics to treat neurodegenerative diseases. Kannalife is the only company in the world that has licensed the use of U.S. Patent 6630507 “Cannabinoids as Antioxidants and Neuroprotectants”, from National Institutes of Health (“NIH”), also patented in the UK; European Union; Ireland; and Australia.
In addition to the IP licenses with NIH, we have filed our own global patent cooperation treaty (PCT) application and have received favorable review prior to publication in 2015. In addition to the U.S. fling, our non-provisional PCT application has also been filed in the European Union, Japan, China, Russia, Canada, Brazil, India, and Australia. Our PCT patent includes several other molecules in addition to KLS-13019 and has been filed for the potential to treat other diseases such as epilepsy, neuropathic pain, traumatic head injury, stroke, Chronic Traumatic Encephalopathy (CTE), Post Cardiac Arrest Hypoxic Ischemic Encephalopathy, Epileptic Encephalopathy, Parkinson’s disease, Alzheimer’s, Huntington’s disease, and amyotrophic lateral sclerosis (ALS).
As we look at the level of investor interest in the “marijuana space”, and considering that many private equity groups; family offices; venture capital groups and high net worth investors have spent a full year getting their powder dry for the eventuality that the DEA would reschedule cannabis (aka: marijuana), we now believe that attention should be put squarely on Kannalife.
We believe that Kannalife merits a high degree of interest as a company that is prepared to drive investor returns in a remarkably similar fashion to the likes of other pharmaceutical companies in the cannabinoid therapeutics space (namely, GW Pharmaceuticals – GWPH:Nasdaq / Zynerba Pharmaceuticals – ZYNE:Nasdaq / Insys Therapeutics – INSY:Nasdaq)
If you would like to learn more about our current offering opportunity and how to make a strategic investment in Kannalife, please contact our Chief Financial Officer, Mark Corrao at: firstname.lastname@example.org. After you have had an opportunity to touch base with Mark and review our collateral materials, I would be happy to join you on a conference call to discuss the investment opportunity in Kannalife as well as our immediate and long term goals.
We look forward to hearing from you
Kannalife Sciences Inc.