Biotechnology Company Signs $8 Million Phase III Contract; Clinical Research and Development Services Corporation to Monitor Endovasc's ANGIOGENIX Phase III Trials.Health/Medical Writers MONTGOMERY, Texas--(BUSINESS WIRE)--Dec. 13, 2002 Endovasc Ltd., Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :ENVC) - a biotechnology company focused in the area of cardiovascular disease, announced today that it signed an $8 million contract with Clinical Research and Development Services, Inc. (CRDS CRDS Contribution pour Le Remboursement de la Dette Sociale (French: Social Debt Repayment Contribution) CRDS Cavity Ring-Down Spectroscopy CRDS Community Rehabilitation and Disability Studies ) of Wayne, NJ to monitor its Phase III human clinical trial of ANGIOGENIX(TM) as a treatment for chronic refractory myocardial ischemia and severe intermittent angina. Clinical Research and Development Services, founded in 1977, is a full service clinical research organization that serves as a research and development resource to the pharmaceutical industry. CRDS has managed over 80 clinical trials over the past 25 years. Dr. Bruce A. Lepp, President of CRDS, will coordinate the work with Endovasc's Project Manager, Mari Livermore. "We are excited about the Angiogenix project and are proud to provide critical clinical services that include clinical site and investigator monitoring, institutional review board (IRB IRB See: Industrial Revenue Bond ) approvals, investigators' meetings and reports and summaries for the NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any preparation and filing. Endovasc has already identified five potential sites for the trial set to commence initially as a pilot dose-ranging trial in the first half of 2003," says Dr. Bruce Lepp, President of CRDS. "I have worked with Dr. Lepp on several projects in the past," says Ms. Livermore, "and without a doubt, his company is one of the most respected contract research organizations (CRO) in the business. CRDS will be a great asset for this trial." Despite popular drugs that may prevent heart disease, ranging from Bristol-Myers Squibb's (NYSE NYSE See: New York Stock Exchange :BMY BMY Bristol Myers Squibb ) Pravachol(R) (pravastatin sodium) to Novartis' (NYSE:NVS NVS - Non-Volatile Storage ) Lescol (fluvastatin fluvastatin /flu·va·stat·in/ (floo´vah-stat?in) an inhibitor of cholesterol biosynthesis used as the sodium salt in the treatment of hyperlipidemia and to slow the progression of atherosclerosis associated with coronary heart disease. ), heart disease remains a serious health problem in the United States. The estimated economic cost of cardiovascular disease is over $250 billion per year. In fact, there are more than 12 million patients with coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. in the U.S. alone. Angiogenix is a revolutionary new cardiovascular drug for recruiting the body's own stem cells that help grow new heart vessels, which is predicted to relieve chest pain and improve heart function. Angiogenix is a simple, small molecule derived from the tobacco plant that, when given in low doses, has demonstrated remarkable results in stimulating robust growth of new vessels in four different animal experiments with simulated blood-flow deficiencies, suggesting that it will do the same in a human patient's heart and limbs. Recent animal studies of Angiogenix have shown no adverse events from the drug even when tested up to 10-fold the recommended dose. Angiogenix has the potential to become a biological alternative to by-pass surgery. The Company believes that it is well ahead of other biotech firms in bringing an angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. drug to market. About Endovasc Endovasc Ltd. Inc., established in 1996, is a biotechnology company focused in the area of cardiovascular disease and pioneering drug-delivery technology that is designed to deliver and release drugs to their intended targets in an efficient and controlled manner. Endovasc is currently testing its two potential drugs ANGIOGENIX(TM) and Liprostin(TM). Its other products include ProStent(TM) stent-coating technology, biodegradable stents and other drug-delivery stents. Endovasc's business model is based on taking on promising drug candidates at the end of the discovery phase and then conducting fast-track programs for the technical and early clinical development phases, covering Phases I and II of the compound. At that point, Endovasc can create separate subsidiaries for each of its drugs, spin them off and issue a stock dividend to its existing shareholders. This model enables Endovasc to receive licensing revenues from its technologies without incurring additional expenses or dilution. For more information about Endovasc, please visit www.endovasc.com. 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. |
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