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news.Pharmos Corporation, which recently entered into a definitive agreement to acquire Vela Pharmaceuticals, has posted news about its cannabinoid drug candidate, cannabinor, revealing that dosing has commenced in a second phase IIa clinical study for the treatment of pain.
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The proof-of-concept trial will test for analgesic activity and the safety of cannabinor (PRS-211,375), a CB2-selective synthetic cannabinoid drug candidate, in healthy subjects experiencing capsaicin-induced pain.
In this phase IIa experimentally induced pain trial, cannabinor will be tested intravenously in a single-center, randomized, double-blinded study that will take place at the UCL Analgesia Centre in London. The safety and analgesic efficacy of cannabinor will be compared with placebo on capsaicin evoked allodynia (pain resulting from a non-noxious stimulus to the skin) and hyperalgesia (abnormally increased pain sense).
The study will include 24 male subjects in a two-way crossover design and is expected to be completed in the fourth quarter of 2006.
The company has also announced that patient enrollment is continuining in its separate phase IIa clinical trial of cannabinor as a treatment for nociceptive pain in third molar dental extraction. This trial is expected to be completed in the third quarter of 2006.
In addition to the ongoing clinical testing of cannabinor in an intravenous formulation, Pharmos is also developing an oral formulation of the drug candidate to move into phase I testing in late 2006 or early 2007.