CV Therapeutics Initiates Phase 1 Clinical Trial of CVT-3619, a Novel Potential Treatment for Cardiometabolic Diseases
September 02 2008 - 8:30AM
PR Newswire (US)
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. DATASOURCE: CV
Therapeutics, Inc. CONTACT: Investors and Media, John Bluth,
Executive Director, Corporate Communications & Investor
Relations of CV Therapeutics, Inc., +1-650-384-8850 Web site:
http://www.cvt.com/
Copyright
CV Therapeutics (NASDAQ:CVTX)
Historical Stock Chart
From Jun 2024 to Jul 2024
CV Therapeutics (NASDAQ:CVTX)
Historical Stock Chart
From Jul 2023 to Jul 2024