Kannalife Sciences, an independent pharmaceutical company founded in 2010, focuses primarily on R&D and commercial use of cannabinoid molecules to treat neurodegenerative diseases. In March 2016 Kannalife received permission from the US Drug Enforcement Agency (DEA) to import pharmaceutical-grade cannabidiol (CBD) for feasibility studies to be conducted in conjunction with Catalent Pharma Solutions.
The imported cannabidiol has no psychoactive effect, but is a synthetic white solid, Kannalife CEO Dean Petkanas told BioPharm International. The substance will be used to formulate the company’s specific proprietary product – KLS-13019, a patented cannabidiol-like therapeutic compound.
Successful completion of the feasibility studies paves the way for the company to file an investigational new drug (IND) application for clinical studies in humans. Kannalife will study the product’s ability to treat Hepatic Encephalopathy (HE) and Chronic Traumatic Encephalopathy (CTE), which are neurodegenerative conditions. HE is a serious neurological disorder that occurs in patients with liver damage or disease and results in toxins (ammonia) being released into the brain, causing neuro-degeneration; CTE results from traumatic brain injury, or repeated blows to the head – common in participants of high impact contact sports like football.
CDB has shown great promise as a neuroprotectant, with the potential to treat many other neurodegenerative diseases including epilepsy, stroke, Parkinson’s disease, and Alzheimer’s.
“We know that CBD is neuroprotective,” says Dr. Bill Kinney, chief science officer at Kannalife. “We have seen effects in both protecting against cell death and increasing cell viability… We think CBD could protect the neurons from future injury and also help them repair.” This has not gone unnoticed in the sports world – Kannalife was recently featured in Sports Illustrated magazine.
“With CTE, and other injuries to the central nervous system, inflammation plays a very important role in exacerbating the injury,” says Ron Tuma, Ph.D., a member of Kannalife’s Scientific Advisory Board. “So it’s the interaction of cannabinoids with the inflammatory process that gives us the hope that it will have therapeutic benefit.”
Re-classification of CBD was under review in the past year by the DEA amid great expectations that cannabis would be rescheduled – perhaps legalized. Conventional thinking is that Schedule 1 classification (a substance with a high potential for abuse without any medical purpose) hinders funding. But in August came the DEA’s unexpected decision – cannabis will remain a schedule 1 controlled substance.
A company press release asserts, “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.’ According to CEO Dean Petkanas, “This news from the DEA validates our business model and our efforts from our inception.”