MONTGOMERY, Texas, April 1, 2004 (PRIMEZONE) -- Endovasc Inc. (OTCBB:EVSC), a drug development company that pioneers new cardiovascular and metabolic drug therapies, announced today the completion of enrollment in the Company's Phase II clinical trial for Liprostin(tm).
The clinical study evaluating patients suffering from peripheral vascular disease (PVD), including critical limb ischemia (CLI) and intermittent claudication (leg pain), but do not require angioplasty, began prescreening candidates in December 2003. Currently there are approximately 80 patients receiving treatment at six clinical sites in Mexico and Europe. Patients admitted to the study were diagnosed with Fontaine IIa or IIb stage of Peripheral Vascular Disease (PVD) and receive six weekly treatments of Liprostin.
According to CEO and President, Dr. Diane Dottavio, "The plan for the study was to enroll up to 120 patients, but based on the initial response from investigators at the clinical sites regarding patient improvement; we have decided to close the enrollment at the end of March. We are extremely pleased to announce that of the patients enrolled in December, a large majority reported experiencing improvement in pain-free walking distance as measured on the treadmill, reduction in resting pain, and an overall improvement in their quality of life."
Critical Limb Ischemia (CLI) is a severe blockage of the arteries that impairs blood flow to the hands, legs and lower extremities, resulting in insufficient levels of oxygen in the affected areas. While CLI is often caused by an acute condition, such as a blood clot, more often it is caused by a chronic condition, such as peripheral vascular disease (PVD). An estimated 8.4 million Americans have peripheral arterial disease and 4.1 million have intermittent claudication. More than 750,000 people in the United States suffer from the disease, and CLI leads to amputation for 200,000 people per year in the Untied States.
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.
About Endovasc
Endovasc, Inc., established in 1996, is an innovative drug development company with two new cardiovascular and metabolic drug therapies. Endovasc's mission is to design the delivery, and release drugs to their intended targets in an efficient and controlled manner. Endovasc's lead drug candidates include Angiogenix(tm) and Liprostin. Endovasc also has a stent coating technology, PROStent(tm), in pre-clinical trials.
For more information about Endovasc, please visit www.endovasc.com.
Safe Harbor
This news release includes statements that are not historical facts and are considered "forward-looking" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Endovascs' current views about future events. They are identified by their use of terms and phrases such as "believe," "expect," "plan," "anticipate", "possibility" and similar expressions identifying their forward-looking character. Investors should not rely on these forward-looking statements as assurances of future events, because such statements are inherently subject to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from the Company's expectations. The factors that may affect the outcome of such expectations include, but are not limited to factors detailed from time to time in the Company's filings with the Securities and Exchange Commission.