Raptor Pharmaceutical Corp. (Nasdaq: RPTP), today announced that data from a clinical trial of NGX426, the Company's orally administered non-opioid, AMPA/kainate antagonist, will be presented at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain, to be held November 20-21, 2009 in San Francisco.
Mark Wallace, M.D., Professor of Clinical Anesthesiology at the Center for Pain Medicine of the University of California at San Diego ("UCSD") will present results from a proof of concept clinical trial titled, "NGX426, An Oral AMPA-Kainate Antagonist, is Effective in Human Capsaicin Induced Hyperalgesia Model." NGX426 is a prodrug of Raptor's parenterally administered product candidate tezampanel. When given subcutaneously and intravenously tezampanel demonstrated statistically significant analgesic effect in five Phase II trials. The five trials were completed in acute migraine, nociceptive pain and neuropathic pain models.
The objective of the single center, double-blind, randomized study conducted by Dr. Wallace was to demonstrate that the orally administered prodrug NGX426, maintains the analgesic effect previously shown for the active moiety tezampanel. Using a cross-over design, a total of 18 study subjects received single doses of 90 mg of NGX426, 150 mg of NGX426 or placebo in each of three treatment periods. Pain was induced by injecting 250 ug of capsaicin between layers of skin in the forearm at 30 minutes and 120 minutes after dosing.
Results and details of the study will be presented on November 20, 2009 during Dr. Wallace's presentation.
Raptor's Chief Medical Officer, Patrice Rioux, M.D., Ph.D., said, "Tezampanel and its oral prodrug NGX426 are the first glutamate receptor antagonists to be tested in human pain trials with combined binding activity at the AMPA and kainite receptor subtypes. In particular, this novel, non-opioid mechanism of action is interesting in the context of neuropathic pain where multiple therapies are typically used to manage the condition."
Christopher M. Starr, Ph.D., Chief Executive Officer of Raptor, commented, "We are hopeful that once released this data will further demonstrate the potential value of NGX426 in the treatment of migraine and chronic pain. We plan to continue to explore our options with NGX426 in the treatment of pain, which potentially include spinning-out or partnering this program, to ensure that our shareholders receive the maximum value from this potentially groundbreaking drug."