GW Pharmaceuticals plc (GWPH, GWP.L), Monday said it has commenced a Phase 1b/2a clinical trial for the treatment of Recurrent Glioblastoma Multiforme or GBM, which is considered a rare, or orphan, disease by the FDA and the European Medicines Agency, or EMA. This study comes after various pre-clinical research conducted by GW in the field of glioma.
The trial 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. Secondary endpoints are additional pharmacokinetic and biomarker analyses and additional measurable outcomes of tumor response.
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