London, UK; 11 November 2013: GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, “GW”) a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced today it has commenced a Phase 1b/2a clinical trial for the treatment of Recurrent Glioblastoma Multiforme (GBM).
Glioma describes any tumor that arises from the glial tissue of the brain. GBM is a particularly aggressive tumor that forms from abnormal growth of glial tissue. According to the New England Journal of Medicine, GBM accounts for approximately 50% of the 22,500 new cases of brain cancer diagnosed in the United States each year. Treatment options are limited and expected survival is a little over one year. GBM is considered a rare, or orphan, disease by the FDA and the European Medicines Agency, or EMA.
This study follows several years of pre-clinical research conducted by GW in the field of glioma which has demonstrated that cannabinoids inhibit the viability of glioma cells both in vitro and in vivoi,ii via apoptosis or programmed cell death, may also affect angiogenesis, and have demonstrated tumor growth-inhibiting action and an improvement in the therapeutic efficacy of temozolomide1, a standard treatment for glioma. In addition, GW has shown tumor response to be positively associated with tissue levels of cannabinoids. GW has identified the putative mechanism of action for our cannabinoid product candidate, where autophagy and programmed cell death are stimulated via stimulation of the TRB3 pathway.
“We are very excited about moving this compound into further human study and the prospects of cannabinoids as new anti-cancer treatments. This is GW’s first clinical study of cannabinoids as a potential treatment to inhibit tumor growth,” stated Dr. Stephen Wright, Director of Research and Development at GW. “We believe this clinical program demonstrates the flexibility and broad application of GW’s cannabinoid platform to treat significant, unmet therapeutic needs.”
This study is a 20-patient, multicentre, two part study with an open-label phase to assess safety and tolerability of GW cannabinoids in combination with temozolomide, and a double blind, randomised, placebo-controlled phase with patients randomised to active or placebo, and with a primary outcome measure of 6 month progression free survival. The study objective is to assess the tolerability, safety and pharmacodynamics of a mixture of two principal cannabinoids, THC and CBD in a 1:1 allocation ratio, in combination with temozolomide in patients with recurrent GBM. Secondary endpoints include additional pharmacokinetic and biomarker analyses and additional measurable outcomes of tumor response.
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ii. Guzman M. Cannabinoids: potential anticancer agents. Nat Rev Cancer 2003;3(10):745-55.