CV Therapeutics' Anti-Ischemic Therapy Ranexa(R) Significantly Reduces Cardiac Chest Pain Symptoms and Recurrent Ischemia in MER
April 01 2008 - 4:01PM
PR Newswire (US)
CHICAGO, April 1, 2008 /PRNewswire-FirstCall/ -- CV Therapeutics,
Inc. (NASDAQ:CVTX) today announced new data presented at the 57th
Annual Scientific Sessions of the American College of Cardiology
shows that Ranexa(R) (ranolazine extended release tablets)
significantly reduced the risk of recurrent ischemia (p=0.002),
worsening angina (p=0.048) and intensification of antianginal
therapy (p=0.009) in angina patients (n=3,565) in the MERLIN- TIMI
36 study. Additionally, Ranexa significantly improved all measures
of exercise performance compared to placebo, including reductions
in the time to onset of angina (p=0.002) and time to the onset of 1
mm ST segment depression (p=0.002), a signal of ischemia, in these
MERLIN-TIMI 36 angina patients. "MERLIN-TIMI 36 is the largest
study of ranolazine in patients with established coronary artery
disease," said David Morrow, M.D., MPH, of Brigham & Women's
Hospital at Harvard Medical School and lead investigator of the
MERLIN-TIMI 36 study. "This new subgroup analysis shows consistent
safety and efficacy across a broader group of angina patients than
those studied previously and reaffirms ranolazine as an option for
treating chronic angina." Study Design MERLIN-TIMI 36 (Metabolic
Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation
Acute Coronary Syndromes) was 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 6,560 patients (3,279 received
ranolazine, 3,281 received placebo) with non-ST elevation ACS
treated with standard therapy. Previously published data from the
MERLIN-TIMI 36 study has shown that Ranexa was safe in this
population of patients with coronary artery disease, which included
nearly 1,100 patients with prior heart failure. Ranolazine had no
effect on the risk of CV death or MI in the study. 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 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' 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' clinical and preclinical drug development candidates
and programs include regadenoson, which is being developed for
potential use as a pharmacologic stress agent in myocardial
perfusion imaging studies. Regadenoson has 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; 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 September 30, 2007. CV Therapeutics
disclaims any intent or obligation to update these forward-looking
statements. DATASOURCE: CV Therapeutics, Inc. CONTACT: John Bluth,
Executive Director, Corporate Communications & Investor
Relations of CV Therapeutics, Inc., +1-650-384-8850 Web site:
http://www.cvt.com/
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