Mark Wallace, M.D. and Professor of Clinical Anesthesiology
at the Center for Pain Medicine of the University of
California 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 called a prodrug of Raptor's parenterally
administered product candidate tezampanel. When it's given
subcutaneously and intravenously tezampanel demonstrated
statistically significant analgesic effect in five
consequtive Phase II trials. The trials were completed
in acute migraine, nociceptive pain
and neuropathic pain models.
The objective of this single center, double-blind,
randomized study by Dr. Wallace was to demonstrate that
the orally administered prodrug NGX426, maintains the
analgesic effect previously shown for the active moiety
tezampanel. When 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 full details of the study will be presented
on November 20, 2009 during Dr. Wallace's presentation.