Kannalife Sciences, Inc. (“Kannalife”) has recently obtained the necessary 2016 quota allotment from the United States Drug Enforcement Agency (DEA) to import high purity pharmaceutical grade cannabidiol (CBD) into the U.S. to continue its ongoing feasibility study being performed by Catalent Pharma Solutions. The goal of the feasibility study is to develop a proprietary drug product formulation for IND enabling pre-clinical studies in animals and clinical studies in humans.
Upon completion of the feasibility study, Kannalife will investigate the product’s ability to treat concussion-related disease chronic traumatic encephalopathy (CTE) and hepatic encephalopathy (HE), which are both neurodegenerative conditions. Both CTE and HE cause severe and often life-threatening side effects that could be mitigated or prevented with the use of CBD hemp oil without the serious and debilitating side effects caused by many existing treatment options. Additional research and development for the drug candidates will occur at the Pennsylvania Biotechnology Center in Doylestown, Penn.
Kannalife holds two National Institutes for Health licenses for a patent “Cannabinoids as Antioxidants and Neuroprotectants.” The patent, licensed by Kannalife, claims CBD could help prevent damage to the central nervous system that leads to degenerative diseases and stress-related conditions.
Kannalife has partnered with Catalent to conduct multiple CBD studies to determine the shelf stability of the products, as well as details about the optimal means of administration in therapeutic treatment. The study is expected to further pre-clinical studies involving human research participants.
CBD, which does not have any psychoactive side effects, is a synthetic substance. Due to the limitations posed by the necessity of creating CBD in a laboratory setting, research has previously been hindered by a lack of formulation materials. Raw API in large quantities is the key to efficient feasibility testing and research. Kannalife CEO Dean Petkanas explained in an interview that the synthetic CBD product had to be imported from a supplier outside of the United States for practical reasons.
Kannalife’s product of note is KLS-13019, a novel CBD-like therapeutic compound that performs almost identically in a treatment setting. The compound is believed to be a possible treatment for oxidative stress-related diseases and could provide more options for sufferers of such conditions. Unlike many prescription drugs currently on the market, KLS-13019 does not result in any psychotropic effects. KLS-13019 is believed to prevent glutamate-induced central nervous system damage, making it proactive as well as efficient at treating damage after the fact.
Because KLS-13019 is not addictive and does not create the high associated with marijuana, it can be used by a broader spectrum of patients. Other formulations of cannabis-based products are in development for different treatment indications. CBD-like compounds created from synthetically derived API are believed to be among the best treatment options for those suffering from chronic traumatic encephalopathy and hepatic encephalopathy.
GW Pharmaceuticals is another company that has recently made headlines in an attempt to develop more CBD oil products. GW focuses on IND treatment applications and its products are currently being examined for effectiveness in this context. The FDA sent various warning letters in early 2016 to companies distributing CBD oil products on the internet due to compliance issues. IND is not considered a dietary supplement, so online retailers who were selling it as such were investigated and warned by the FDA.
Kannalife is changing the face of the CBD-derived treatment industry with this new series of feasibility studies. Because laboratory resources for the creation of KLS-13019 are limited, the DEA’s approval for importation marks a major step in the direction of improving treatment options for patients around the country. For the time being, the imports are limited to the studies being conducted at the Pennsylvania Biotechnology Center, but future import permissions may be granted depending on the outcomes of the research.
As Kannalife leads the way for innovation in CBD-like treatment options, sufferers of neurodegenerative conditions such as HE will have more options to choose from. These treatments offer relief from severe neurological symptoms, allowing patients to regain their quality of life without the use of habit forming substances. In the future, more lenient import permissions for the manufacturing and sale of synthetic products such as KLS-13019 may allow research to branch out into other treatment indications.
About the Author
Stuart Smith is the CEO and Founder of SmallCapVoice.com. SmallCapVoice.com. is a recognized corporate investor relations firm, with clients nationwide, known for its ability to help emerging growth companies build a following among retail and institutional investors. SmallCapVoice.com utilizes its stock newsletter to feature its daily stock picks, audio interviews, as well as its clients’ financial news releases. SmallCapVoice.com also offers individual investors all the tools they need to make informed decisions about the stocks they are interested in. Tools like stock charts, stock alerts, and Company Information Sheets can assist with investing in stocks that are traded on the OTC BB and Pink Sheets. To learn more about SmallCapVoice.com and their services, please visit http://smallcapvoice.com/blog/the-small-cap-daily-small-cap-newsletter/