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GW Begins GBM Trial

Cannabinoid research leads to potential orphan treatment

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

GW Pharmaceuticals has initiated a Phase Ib/IIa clinical trial for the treatment of Recurrent Glioblastoma Multiforme (GBM). The company will conduct a 20-patient, multicenter, two-part study with an open-label phase to assess safety and tolerability of GW cannabinoids in combination with temozolomide, as well as a double-blind, placebo-controlled phase with patients randomized to active or placebo, with a primary outcome measure of six-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.

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. 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.

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