MONTGOMERY, Texas, Jan. 22, 2004 (PRIMEZONE) -- Endovasc Inc. (OTCBB:EVSC), a drug development company that pioneers new cardiovascular and metabolic drug therapies, is pleased to announce that Liprostin(TM) has been shipped to Moscow to be used in the Company's multi-center phase II clinical trial for patients suffering from Peripheral Vascular Disease. Four clinical sites in Moscow have begun screening patients suffering from peripheral vascular disease (PVD), including critical limb ischemia (CLI) and intermittent claudication (leg pain), but do not require angioplasty and are ready to begin treating patients as soon as the drug arrives.
On September 29, 2003, an investigator's meeting was held at the National Hotel in Moscow. The medical teams headed by Dr. Boris A. Sidorenko of the Scientific Center of President Medical Center, Central Medical Hospital and Dr. Anatoly V. Procrovsky of the Vishnevsky Surgical Institute met to go over plans for the phase II clinical trial. Since that time, the cardiovascular teams led by Dr. Valery S. Arakelyan, MD, PhD at the A.N. Bakulev Research Center of Cardiovascular Surgery and Professor Sergei B. Fitilev, MD, PhD, at the Moscow Hospital of Glavmosstroy have also agreed to participate in the trial. All four sites have begun screening individuals for Endovasc's 120 patient, open-label, multi-center trial of Liprostin. Each site plans to enroll ten to twenty patients. Walking distance and leg pain will be measured over the three-month duration of the trial. Patients responding significantly to the treatment regimen may be recommended by their physician to continue the treatments past the three month time period established for the study.
CEO and President, Dr. Diane Dottavio stated, "We are very pleased to be opening these four additional sites in this very important clinical trial. Critical limb ischemia is a very severe condition of peripheral vascular disease and there are currently no drugs approved for its treatment. More than 750,000 people in the United States suffer from the disease, which leads to amputation for 200,000 people per year in the Untied States. Additionally, up to 10 million people in the United States suffer from severe leg pain (claudication) and non-healing ulcers, both of which result from CLI."
Critical limb ischemia is a disease manifested by sharply diminished blood flow to the legs. Endovasc's Liprostin is a liposome-encapsulated form of prostaglandin E-1 (PGE-1). PGE-1 is known to be a potent vasodilator and platelet inhibitor, as well as an anti-inflammatory and anti-thrombotic agent. The encapsulated formulation (Liprostin) has been shown to improve the therapeutic index of PGE-1, positively impacting many areas of treatment, such as heart attacks, occlusive disease, ischemic ulcers, critical limb salvage, claudicants, and arthritis.
Safe Harbor Statement
The foregoing statements are made under the "Safe Harbor" Private Securities Litigation Reform Act of 1995 and may contain forward-looking statements that involve risks and uncertainties that may not be evident at the time of this release. For more information about Endovasc, please visit www.endovasc.com.