BURLINGAME, Calif., Dec. 8 /PRNewswire/ -- Angiogenix, Inc., a privately held biopharmaceutical company, today announced the initiation of a Phase II clinical trial of its lead product candidate, ACCLAIM(TM), for the treatment of chronic angina, the chest pain that occurs from inadequate blood flow to the coronary arteries around the heart. ACCLAIM (organic nitrate combined with L-arginine), is an oral proprietary nitrate therapeutic shown to induce coronary vasodilation while overcoming the significant problem of drug tolerance.
Nitrate therapy, the current standard treatment option for patients with chronic angina, has a proven track record of facilitating coronary vasodilation. Vasodilation results in improved blood flow, improved cardiac function and elimination of angina. However, scientific research has demonstrated that ongoing treatment with nitrates results in a condition known as nitrate tolerance, which can lead to reduced vasodilation. Tolerance to nitrates, which develops due to the cellular depletion of L-arginine, significantly limits the effectiveness and usefulness of all existing nitrate drugs. In order to prevent tolerance, patients must include a "nitrate-free interval" in every 24-hour period. During this time, patients do not receive the effective symptom relief associated with nitrate therapy.
ACCLAIM is a proprietary combination of nitrate and L-arginine that provides the beneficial cardiovascular effects of nitrates. Combining L-arginine with organic nitrates prevents the endothelial cell's depletion of L-arginine and the associated problem of nitrate tolerance. By eliminating nitrate tolerance, ACCLAIM allows patients to receive the continuous, 24-hour benefit of a potent nitrate product, thus sustaining the desired vasodilation effect.
"As the first new entry into the $2 billion worldwide nitrate product market in 10 years, ACCLAIM represents a significant improvement in this line of cardiovascular therapy," stated Edmon R. Jennings, Angiogenix' President and Chief Executive Officer. "Nitrate tolerance currently limits the effectiveness of all available nitrate products. By overcoming this serious limitation, ACCLAIM can provide patients the solution they have long needed: a nitrate therapy that provides 24-hour, uninterrupted relief from the debilitating symptoms of angina."
About the Trial
The Phase II, randomized, double-blind, placebo-controlled trial will enroll 170 patients with documented coronary artery disease who suffer from chronic, stable, effort-induced angina. Patients will be given a treadmill exercise test to determine the effect of ACCLAIM on relieving their symptoms of angina. The endpoint for the trial, which will be conducted at cardiology centers in eight countries around the world, is treadmill walking time (TWT) determined from the beginning of the exercise test until the patient develops angina of moderate degree.
Angiogenix, Inc. is a biopharmaceutical company focused on the research and development of novel drugs for the treatment of cardiovascular disease, with particular emphasis on disease caused by underlying ischemia. Angiogenix is currently developing two product candidates, ACCLAIM(TM) and Vasotrophin(TM), targeting several of the largest cardiovascular markets.
For more information please visit Angiogenix' website at http://www.angiogenix.com/.
CONTACT: Edmon R. Jennings, President and CEO of Angiogenix, Inc.,+1-650-552-0072; or investors, Stephanie Diaz, +1-415-885-2298, or media,Tim Brons, +1-646-319-8981, both of Vida, LLC, for Angiogenix, Inc.