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CV Therapeutics Initiates Phase 1 Clinical Trial of CVT-3619, a Novel Potential Treatment for Cardiometabolic Diseases

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 the release of free fatty acids from fat cells and has the potential to meet a tremendous unmet need by potentially treating both dyslipidemia and diabetes. We look forward to the clinical development of this innovative medication," said Ralph A. DeFronzo, M.D., professor of medicine and chief of the diabetes division at the University of Texas Health Science Center in San Antonio, Texas.

About CV Therapeutics

CV Therapeutics, Inc., headquartered in Palo Alto, California, is a biopharmaceutical company primarily focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases. CV Therapeutics Ltd. is the company's European subsidiary based in the United Kingdom.

CV Therapeutics' approved products in the United States include Ranexa(R) (ranolazine extended-release tablets), indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and Lexiscan(TM) (regadenoson) injection for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. Ranexa is also approved for use in the European Union as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies.

Except for the historical information contained herein, the matters set forth in this press release, including statements as to research and development and commercialization of products, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including operating losses and fluctuations in operating results; capital requirements; regulatory review and approval of our products; special protocol assessment agreement; the conduct and timing of clinical trials; commercialization of products; market acceptance of products; product labeling; concentrated customer base; reliance on strategic partnerships and collaborations; uncertainties in drug development; uncertainties regarding intellectual property and other risks detailed from time to time in CV Therapeutics' SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2008. CV Therapeutics disclaims any intent or obligation to update these forward-looking statements.

SOURCE CV Therapeutics, Inc.
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