GW Pharmaceuticals Initiates Phase 2 Clinical Study of Cannabidivarin (CBDV) in Epilepsy
"The start of this Phase 2 CBDV study represents another important milestone for GW's research in the field of epilepsy," stated
This study is a two-part, Phase 2, double blind, randomized, placebo controlled study. Part A is designed to investigate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo in 30 patients, as add-on therapy in patients with inadequately controlled focal seizures. Part B will evaluate the efficacy of GWP42006 compared with placebo in 100 patients, as add-on therapy to treat inadequately controlled focal seizures.
This study follows completion of a Phase 1 trial in 66 healthy subjects in 2014. In this trial, 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.
GW's patent portfolio related to CBDV includes a granted patent in
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside
This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of the company's investigational product candidates, the development and commercialization of such product candidates, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the
acceptance of Sativex®, Epidiolex®, and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW's filings with the
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