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Endovasc concludes Liprostin phase II FDA clinical trial
Montgomery | Tuesday, July 20, 2004, 08:00 Hrs  [IST]

Endovasc Inc, a drug development company, announced the conclusion of its phase II Liprostin Clinical Trial for patients suffering from Peripheral Vascular Disease (PVD). The purpose of the trial was to determine if Liprostin could possibility postpone or eliminate the need for surgical intervention.

The trials' efficacy endpoints include Maximum Walking Distance (MWD) and Pain Free Maximum Walking Distance (PFMWD) compared to baseline. In the Company's initial assessment of the patients to complete the trial, there has been a marked improvement in both Maximum Walking Distance and Pain Free Maximum Walking Distance compared to baseline, a company release says.

Endovasc anticipates that this trend will continue in further patient data resulting in a successful trial. Endovasc is currently evaluating the Case Report Forms (CRF) as they are being received from the clinical sites.

Peripheral vascular disease is a condition in which the arteries that carry blood throughout the body become narrowed or clogged, resulting in diminished blood flow.

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.

The market potential of Liprostin is estimated to be in excess of 100 million dollars annually. In the United States, as many as 10 million Americans over the age of 40 have PAD and it is estimated that approximately 20 per cent of people ages 55 and older in the United States have PAD, which represents a significant opportunity. Currently, the company is reviewing a number of financial strategies to move Liprostin into a Phase III trial.

Endovasc's lead drug candidates include Angiogenix and Liprostin.

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