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Endovasc Outlines Plans for Continued Development of Liprostin; Promising Phase II Clinical Trial Results Warrant Further Trials

Posted on: Tuesday, 7 December 2004, 09:00 CST

Endovasc Inc. (OTCBB: EVSC), an early-stage drug development company that pioneers new cardiovascular and metabolic drug therapies, is pleased to announce its plans for the future development of Liprostin, a liposome-encapsulated form of prostaglandin E-1. The Company has hired a full-service Contract Research Organization (CRO), with expertise in all areas of clinical trials and clinical research.

With the recent successful completion of the Liprostin phase II trial, Endovasc is working towards initiating a phase III trial in 2005. The company is currently finalizing the necessary documents to be submitted to the FDA, as well as designing a Phase III protocol. With respect to this effort, Endovasc has recently retained the services of Synergos, Inc., a Houston based CRO, to assist in the preparation of these documents.

Diane Dottavio, Chief Executive Officer of Endovasc, commented, "We are preparing the necessary paperwork to communicate our Liprostin data to the FDA. Synergos provided strategic regulatory and clinical direction to the Company during the Liprostin Phase I study and assisted in the regulatory submissions for that trial. We have engaged Synergos to manage this submission process to the FDA for the critical Phase II data. With the progress that has been made this year, we are extremely positive regarding the prospects of Liprostin. Our internal estimates indicate that Liprostin sales would exceed $100 million annually upon marketing approval in the United 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 Synergos

Synergos, Inc. a Contract Research Organization, provides comprehensive clinical research and development services, from study design through regulatory submission. Founded in 1991, Synergos, Inc. has gained substantial experience in pharmaceuticals, medical devices and biotechnology product development, with significant expertise in numerous therapeutic and diagnostic areas. To date, they have managed, analyzed, and produced reports for each type of regulatory submission required by the FDA, including multiple NDAs and PMAs.

About Endovasc

Endovasc, Inc., established in 1996, is a Business Development Company focused on innovative drug development in the areas of cardiovascular and metabolic medicine. Endovasc's Subsidiaries include; Liprostin Incorporated, which holds the intellectual property for a liposomal based treatment to increase circulation, and reduce leg pain in patients suffering from vascular disease; Angiogenix Limited which retains the sublicense for an isomer of nicotine that has shown to recruit the body's own stem cells that help grow new blood vessels, aiming to relieve chest pain and improve heart function in patients with chronic myocardial ischemia; and Nutraceutical Development Corporation which has an agreement in place with an innovative product development company to commercialize its muscle mass enhancing product. Endovasc recently announced its intention to create a new subsidiary to showcase its promising ProStent technology with is a patented stent coating comprised of a polymer and prostaglandin E1 (PGE1).

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 please visit the Company's SEC filings, as well as, the Company's website, www.endovasc.com.

Source: Business Wire

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