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

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.

Investors and Media, John Bluth, Executive Director, Corporate Communications
& Investor Relations of CV Therapeutics, Inc., +1-650-384-8850