Endovasc Outlines Plans for Continued Development of Liprostin; Promising Phase II Clinical Trial Results Warrant Further Trials.MONTGOMERY, Texas -- Endovasc Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : EVSC EVSC Evansville Vanderburgh School Corporation ), 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , 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 vasodilator /vaso·di·la·tor/ (-di-la´ter) 1. causing dilatation of blood vessels. 2. a nerve or agent that does this. va·so·di·la·tor n. 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 occlusive /oc·clu·sive/ (o-kloo´siv) pertaining to or causing occlusion. oc·clu·sive adj. 1. Occluding or tending to occlude. 2. disease, ischemic Ischemic An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery. Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation ischemic ulcers, critical limb salvage limb salvage Orthopedics The returning of a limb to a state of reasonable functionality after severe trauma that might otherwise result in amputation. See Amputation. , 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 isomer (ī`səmər), in chemistry, one of two or more compounds having the same molecular formula but different structures (arrangements of atoms in the molecule). Isomerism is the occurrence of such compounds. of nicotine that has shown to recruit the body's own stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young 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 (PGE PGE Pacific Gas and Electric Company PGE Portland General Electric PGE Prostaglandin E PGE Platinum Group Elements PGE Pacific Great Eastern (Railroad) PGE Phenyl Glycidyl Ether PGE Perfect Girl Evolution 1). The foregoing statements are made under the "Safe Harbor" Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion