CBDV Phase 1 Safety Results and Patent Allowance
Type 2 Diabetes Phase 2b Trial Commences
Schizophrenia Phase 2 Trial CommencesLONDON, March 17, 2014 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) (LSE:GWP) ("GW," "the Company" or "the Group"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today provided an update on the Company's cannabinoid pipeline. "While much of the recent attention regarding GW has been associated with our childhood epilepsy and cancer pain development programs, we continue to make great progress with other pipeline programs, further demonstrating the breadth of our proprietary cannabinoid product development platform to yield interesting and therapeutically beneficial product candidates." stated Dr. Stephen Wright, GW's Director of Research and Development. "As GW continues to progress its clinical work with cannabinoids, our pipeline has the potential to yield, as it did with Epidiolex, a flow of exciting new product candidates in a wide variety of therapeutic areas." GWP42006 (CBDV) for epilepsy GW has completed a Phase 1 clinical trial of GWP42006 to treat epilepsy. GWP42006 is a product which features the non-psychoactive cannabinoid cannabidivarin (CBDV) extracted from the cannabis plant. This Phase 1 single ascending and multiple dose pharmacokinetic and safety study in 66 healthy subjects demonstrated no safety or toxicity signals. In this study, subjects were dose titrated to investigate the maximum tolerated dose and to determine what, if any, side effects resulted. CBDV was well tolerated even at the highest tested dose and no significant side effects were observed. There were no serious or severe adverse events, nor any withdrawals due to adverse events, and all mild adverse events resolved on treatment. CBDV has shown the ability to treat seizures in pre-clinical models of epilepsy with significantly fewer side effects than currently approved anti-epileptic drugs 1. CBDV also appears to employ a different mechanism of action to currently available anti-epileptic treatments. GW expects to commence a Phase 2 study of CBDV in patients with epilepsy later in 2014, using the doses identified as appropriate in this Phase 1 study. GW also announced that the Intellectual Property Office in the United Kingdom has granted a patent for the use of CBDV in the treatment of epilepsy, patent number GB2479153B. The subject patent covers the use of CBDV alone or in combination with standard anti-epileptic drugs or in combination with other cannabinoids, and provides an exclusivity period until 30 March 2030. This same patent is currently in prosecution with the United States Patent and Trademark Office.