Pharmos Corporation (Nasdaq: PARS), which recently entered into a definitive agreement to acquire Vela Pharmaceuticals Inc. (Vela), announced today that it has commenced dosing for its Phase 2a clinical study of cannabinor (PRS-211,375), a CB2-selective synthetic cannabinoid drug candidate for the treatment of pain. Since receiving approval to initiate the study in the U.K. last week, the first 3 patients have been treated. Pharmos expects to complete the trial in the third quarter of 2006.
The single-center, randomized, double-blinded, single-dose intravenous study will include 100 healthy male subjects. The trial is being conducted at the UCL Analgesia Centre in London. The safety and analgesic efficacy of different cannabinor doses will be compared with placebo for acute pain following extraction of mandibular third molar teeth.
Shimon Amselem, Ph.D., V.P. Pharmaceutical Development and Head of the Cannabinor Project said, "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 2a 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. Oral cannabinor for chronic pain treatment has entered toxicology studies in animals. We believe that cannabinor is the first CB2-selective agonist entering Phase 2 clinical testing, illustrating Pharmos' strong position in cannabinoid-CB2-selective development."
Alan L. Rubino, President & COO, said, "As we continue to develop cannabinor and work to advance into the clinic other promising drug candidates from our extensive library of CB2-selective compounds, we look forward to further expanding our later-stage pipeline by adding Vela's drug assets. We believe that the combined growth engines of the cannabinoid platform and dextofisopam for IBS will contribute considerably to building shareholder value in Pharmos. We also anticipate that the broadened pipeline will attract potential pharmaceutical partners and we have retained Burrill & Company to help us structure and monetize such partnership arrangements." Subject to shareholder approval, Pharmos expects the acquisition of Vela to close in the third quarter 2006.
Vela's lead drug, dextofisopam, has undergone one Phase 2 trial showing positive indications for potential efficacy in treating irritable bowel syndrome (IBS), a prevalent disorder for which existing treatment options are very limited. Dextofisopam has the potential to address two of the three major segments of the IBS population -- diarrhea-predominant patients and patients with alternating diarrhea and constipation -- corresponding to nearly 70 percent of all diagnosed cases. The Vela pipeline also includes VPI-013, in-licensed from Otsuka Pharmaceutical Co., Ltd. VPI-013 significantly improved overall sexual function, desire/frequency and desire/interest in Phase 2 clinical testing in depressed patients.
According to Arifulla Khan, M.D., Medical Director, Northwest Clinical Research Center, Bellevue, Washington, and the lead investigator for Vela's Phase 2 trial, the Phase 2 VPI-013 data "strongly suggest VPI-013 improved libido and therefore may have potential for treating sexual dysfunction in men and women." Tianeptine, a compound for which abundant clinical safety data already exists, is a potential follow-on molecule to dextofisopam for the treatment of functional GI disorders.