Endovasc Ltd. Inc has signed an $8 million contract with Clinical Research and Development Services Inc (CRDS) of Wayne, NJ to monitor its Phase III human clinical trial of Angiogenix 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) approvals, investigators' meetings and reports and summaries for the NDA 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 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 Pravachol (pravastatin sodium) to Novartis' Lescol (fluvastatin), 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 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 drug to market.