CV Therapeutics Announces Topline MERLIN TIMI-36 Results
March 06 2007 - 4:01PM
PR Newswire (US)
- Full study results will be presented at the American College of
Cardiology's Scientific Session - PALO ALTO, Calif., March 6
/PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX)
announced today that an analysis of unblinded data from the MERLIN
TIMI-36 study of ranolazine shows there was no adverse trend in
death or arrhythmias in patients on ranolazine. The study did not
meet the primary efficacy endpoint. In accordance with the
company's special protocol assessment agreement with the U.S. Food
and Drug Administration (FDA), the company believes that the data
could support expansion of the existing Ranexa(R) (ranolazine
extended-release tablets) indication to include first line angina.
Complete data are scheduled to be presented as a late breaking
clinical trial on Tuesday, March 27 at 8:50 a.m. central time
during the 2007 American College of Cardiology Scientific Session
in New Orleans. Study Design MERLIN TIMI-36 (Metabolic Efficiency
with Ranolazine for Less Ischemia in Non-ST Elevation Acute
Coronary Syndromes) is a multi-national, double-blind, randomized,
placebo-controlled, parallel-group clinical trial designed to
evaluate the efficacy and safety of Ranexa during acute and
long-term treatment in approximately 6,500 patients with non-ST
elevation ACS treated with standard therapy. Within 48 hours of the
onset of angina due to ACS, eligible hospitalized patients were
enrolled in the study and randomized to receive intravenous Ranexa
or placebo, followed by long-term outpatient treatment with Ranexa
extended-release tablets or placebo. All patients also received
standard therapy during both hospital-based and outpatient
treatment. The doses of Ranexa extended-release tablets used in
MERLIN TIMI-36 have been studied in previous Phase 3 clinical
trials. Currently, Ranexa is indicated for the treatment of chronic
angina in patients who have not achieved an adequate response with
other antianginal drugs, and should be used in combination with
amlodipine, beta-blockers or nitrates. About Angina Chronic angina
is a serious and debilitating heart condition, usually associated
with coronary artery disease and marked by repeated and sometimes
unpredictable attacks of chest pain. Approximately 8.9 million
people in the United States have chronic angina, and 400,000 new
cases are diagnosed annually, according to the American Heart
Association. Ranexa has anti-ischemic effects which do not depend
on changes in heart rate or blood pressure. About CV Therapeutics
CV Therapeutics, Inc., headquartered in Palo Alto, California, is a
biopharmaceutical company focused on applying molecular cardiology
to the discovery, development and commercialization of novel, small
molecule drugs for the treatment of cardiovascular diseases. CV
Therapeutics' approved product, Ranexa(R) (ranolazine
extended-release tablets) is indicated for the treatment of chronic
angina in patients who have not achieved an adequate response with
other antianginal drugs, and should be used in combination with
amlodipine, beta-blockers or nitrates. CV Therapeutics also has
other clinical and preclinical drug development candidates and
programs, including regadenoson, which is being developed for
potential use as a pharmacologic stress agent in myocardial
perfusion imaging studies, and CVT-6883, which is being developed
as a potential treatment for asthma and other conditions.
Regadenoson and CVT-6883 have not been determined by any regulatory
authorities to be safe or effective in humans for any use. 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; and other risks detailed from time to time in CV
Therapeutics' SEC reports, including its Annual Report on Form 10-K
for the quarter ended December 31, 2006. CV Therapeutics disclaims
any intent or obligation to update these forward-looking
statements. DATASOURCE: CV Therapeutics, Inc. CONTACT: Investor and
Media Contact: John Bluth, Senior Director, Corporate
Communications and Investor Relations, CV Therapeutics, Inc.,
+1-650-384-8850, or Investor Contact: Dahlia Bailey, Senior
Investor Relations Manager, CV Therapeutics, Inc., +1-650-384-8585
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