NEW YORK, Aug. 11, 2015 — Kannalife Sciences, Inc., a Phyto-Medical Company, describes orphan drug opportunity for KLS-13019, a Novel Functionalized 1,3-Benzene Diol for the Treatment of Hepatic Encephalopathy recently published in PCT Patent WO2015/106108A2.
“Our pre-clinical studies using cannabidiol (CBD) as a positive control, side-by-side with KLS-13019 and other cannabidiol-like molecules of this class, reveals dramatic potency and safety improvements for this novel chemotype. Kannalife’s patent application further describes the novel chemotype useful as neuroprotective agents in the treatment of diseases associated with hepatic encephalopathy. KLS-13019 demonstrated improved oral bioavailability and CNS penetration relative to CBD and bodes well for its ability to penetrate the blood brain barrier, ameliorate brain toxicities associated with HE, and address unmet medical needs,” stated Dean Petkanas, CEO of Kannalife.
In 2010, Salix Pharmaceuticals’ drug Xifaxan® (Rifixamin), received priority review under FDA’s new drug application process and was granted orphan designation status for their HE indication. Priority review is designed to expedite programs on new drug applications for serious conditions. Orphan status grants seven years exclusivity. It is estimated that there are 1.5 million sufferers of hepatic encephalopathy (HE) in the US, of which, approximately 200,000 patients suffer from overt hepatic encephalopathy (Grade 3), representing an orphan drug opportunity for a novel drug in use.
Petkanas further stated, “In 2010 we believed there was an opportunity to build upon the promising preclinical findings with CBD in HE and design a novel cannabidiol-like therapeutic agent that would have benefits in terms of therapeutic index and delivery by the oral route. Developing our New Chemical Entity via the orphan status pathway will provide advantages in terms of reduced development cost and greater exclusivity in the marketplace.”
According to a report by Credit Suisse, Xifaxan® sales to treat Hepatic Encephalopathy accounted for roughly 70% of total Salix sales and is estimated to deliver approximately $900 million in 2015 with estimates driving towards $1.4 billion by 2018.
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About Kannalife Sciences, Inc.
Kannalife Sciences, Inc. is a phyto-medical company involved in the research and development of novel therapeutic agents designed to be neuroprotectants and immuno-modulators. KannaLife is currently conducting research and development at the Pennsylvania Biotechnology Center in Doylestown, PA, for target drug candidates to treat Hepatic Encephalopathy (“HE”) and Chronic Traumatic Encephalopathy (“CTE”). HE and CTE are oxidative stress related diseases that affect cognitive and behavioral functions. For more information, visit www.kannalife.com