Since receiving approval to initiate the study in the UK recently, the first three patients have been treated. Pharmos expects to complete the trial in the third quarter of 2006.
The single-dose intravenous study will include 100 healthy male subjects. The trial is being conducted at the UCL Analgesia Centre in London, UK. The safety and analgesic efficacy of different cannabinor doses will be compared with placebo for acute pain following extraction of mandibular third molar teeth.
“Data from preclinical testing of cannabinor suggest that the compound holds strong promise as an analgesic for pain treatment. We are also preparing a phase IIa intravenous study to test the analgesic efficacy and safety of cannabinor in experimentally induced neuropathic pain, which we expect to commence in the third quarter this year,” said Dr Shimon Amselem, VP of pharmaceutical development at Pharmos and head of the cannabinor project.
Pharmos recently entered into a definitive agreement to acquire Vela Pharmaceuticals, which has a lead drug candidate in mid-phase development for the treatment of irritable bowel syndrome.