CV Therapeutics Reports Phase 1 Data Showing Proof of Concept for CVT-3619, a Novel Potential Treatment for Cardiometabolic Dise
March 05 2009 - 8:30AM
Marketwired
CV Therapeutics, Inc. (NASDAQ: CVTX) announced today that CVT-3619,
a novel oral compound for potential treatment of cardiometabolic
diseases, was well tolerated with no serious adverse events and was
associated with a reduction of free fatty acids (FFA).
"Elevated FFA levels cause insulin resistance and have emerged
as a major link between obesity, metabolic syndrome and
atherosclerotic vascular disease. CVT-3619 has great potential as a
first-in-class pharmacological approach to normalize increased
plasma FFA levels and address some of the downstream clinical
consequences," said Dr. Guenther Boden, M.D., chief, section of
endocrinology, diabetes and metabolism, professor of medicine at
Temple University, Philadelphia.
This Phase 1, single-blind, placebo-controlled, single ascending
dose study evaluated the safety, tolerability and pharmacokinetics
of oral CVT-3619, a partial A1 adenosine receptor agonist, in 55
healthy and 23 obese volunteers. No clinically meaningful changes
in heart rate or blood pressure were observed in the study.
"The exciting initial data from this clinical trial are
consistent with our preclinical observations that CVT-3619 causes
dose-dependent reductions of circulating FFA," said Luiz
Belardinelli, M.D., senior vice president of clinical research and
pharmacology at CV Therapeutics.
CVT-3619, in preclinical models, has been shown to bind to the
A1 adenosine receptors on fat cells, called adipocytes, leading to
a reduction in the breakdown of fats, also known as lipolysis,
thereby resulting in a lowering of FFA . Preclinical studies have
also shown that CVT-3619 improves insulin sensitivity reduces
elevated triglycerides and lowers very low density lipoproteins and
therefore may potentially raise high density lipoproteins.
The data showed CVT-3619 was safe and well tolerated in this
study up to a single dose of the highest dose tested, 1,800 mg in
healthy subjects and up to 1,500 mg in overweight or obese
subjects, with no serious adverse events. The most common adverse
event observed in the study was headache, which was evenly
distributed through the groups, including placebo. In the same
study, additional exploratory analyses of pharmacodynamic effects
in healthy and obese volunteers show a dose dependent reduction in
FFA.
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 Europe Ltd. is the
company's European subsidiary based in the United Kingdom.
CV Therapeutics' approved products in the United States include
Ranexa� (ranolazine extended-release tablets), indicated for the
treatment of chronic angina, and Lexiscan� (regadenoson) injection
for use as a pharmacologic stress agent in radionuclide myocardial
perfusion imaging in patients unable to undergo adequate exercise
stress.
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; 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 Annual Report on Form 10-K for the year ended
December 31, 2008. CV Therapeutics disclaims any intent or
obligation to update these forward-looking statements.
Investor and Media Contact John Bluth Executive Director
Corporate Communications & Investor Relations CV Therapeutics,
Inc. (650) 384-8850
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