MONTGOMERY, Texas, Jan. 28, 2004 (PRIMEZONE) -- Endovasc Inc. (OTCBB:EVSC), a drug development company that pioneers new cardiovascular and metabolic drug therapies, announced today that Liprostin(TM) was shipped to Mexico City this week to be used in Endovasc's multi-center phase II clinical trial for patients who suffer from peripheral vascular disease (PVD), including critical limb ischemia (CLI) and intermittent claudication (leg pain), but do not require angioplasty.
The two sites in Mexico have already prescreened applicants and are awaiting the shipments to begin treating patients. These two clinical sites in Mexico, in addition to the existing sites in Russia and Georgia, bring the number of sites treating patients to seven. It is estimated that the sites in Mexico City will each enroll between ten and twenty patients. The trial is anticipated to last for three months.
Critical limb ischemia is a disease manifested by sharply diminished blood flow to the legs. 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. 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. CLI is a very severe condition of peripheral vascular disease; there are currently no drugs approved for its treatment.
Although the FDA waived Endovasc's requirement for Phase I and II trials in their November 1999 pre-IND meeting with the Company, management and Endovasc's scientific team determined that the implementation of a modified Phase II trial would be critical to gathering the needed dose and treatment regiment data to design a Phase III study. Previous studies have demonstrated that PGE-1 can increase blood circulation, and reduce leg pain by increasing the oxygen and nutrients in blood-starved muscles. Prostaglandin E-1 antagonizes blood clot formation by preventing platelets from sticking together. This has the potential to greatly improve the outcome for these patients.
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.