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CV Therapeutics Initiates Phase 1 Clinical Trial of CVT-3619, a Novel Potential Treatment for Cardiometabolic Diseases
Date:9/2/2008

PALO ALTO, Calif., Sept. 2 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX) announced today that the company has enrolled the first patient in a Phase 1 trial of CVT-3619, a novel oral compound for potential treatment of cardiometabolic diseases. The U.S. Food and Drug Administration recently accepted the Company's investigational new drug application for CVT-3619, a partial A1 adenosine receptor agonist.

This Phase 1 trial will assess the safety and pharmacokinetic profile of CVT-3619 in healthy volunteers. The Phase 1 program will provide early data on the compound's potential effects on circulating levels of free fatty acids, which are associated with high blood lipid levels, insulin resistance and other cardiometabolic risk factors.

"Despite current therapies, millions of Americans continue to suffer from both heart disease and diabetes. CVT-3619 is a first in class, potent, orally available new chemical entity that targets yet untreatable aspects of dysfunctional metabolism in these patients," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics. "CVT-3619 was invented by CV Therapeutics and represents our fourth clinical program to complement our two approved products."

CVT-3619 binds to the adenosine A1 receptor on fat cells, called adipocytes, potentially leading to a reduction in the breakdown in fats, also known as lipolysis, and a lowering of free fatty acids in preclinical models. Preclinical studies also have shown that CVT-3619 improves insulin sensitivity, reduces elevated triglycerides, and may lower very low density lipoproteins and potentially raise high density lipoproteins.

"CVT-3619 represents a first-in-class agent that appears to inhibit
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SOURCE CV Therapeutics, Inc.
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