CV Therapeutics Completes MERLIN TIMI-36 Study
September 26 2006 - 8:00AM
PR Newswire (US)
Study Close-Out Now Underway; Top Line Results Expected in First
Quarter of 2007 PALO ALTO, Calif., Sept. 26 /PRNewswire-FirstCall/
-- CV Therapeutics, Inc. (NASDAQ:CVTX) announced today that the
MERLIN TIMI-36 study of ranolazine will proceed to the study
close-out phase, followed by unblinding and analysis of the data,
now that the required number of endpoints have accumulated. The
study's duration was event driven. The protocol pre-specified that
the study would conclude after at least 730 major cardiovascular
events, as defined in the study protocol, and 310 deaths from any
cause. More than 1,000 major cardiovascular events and 310 deaths
have now been recorded. The MERLIN TIMI-36 study is being conducted
by the Harvard-based Thrombolysis In Myocardial Infarction (TIMI)
Study Group, under the direction of Eugene Braunwald, M.D. and
David Morrow, M.D. To complete the close-out portion of the study,
MERLIN TIMI-36 patients will come in for a final study visit and
the 440 enrolling study sites in 17 countries will be closed out.
Top line data could be available in the first quarter of 2007. The
primary efficacy endpoint in MERLIN TIMI-36 is time to first
occurrence of any element of the composite endpoint of
cardiovascular death, myocardial infarction or recurrent ischemia
in patients with non-ST elevation acute coronary syndromes (ACS)
receiving standard therapy. The study also evaluates the safety of
long-term treatment with Ranexa(R) (ranolazine extended-release
tablets) compared to placebo. According to a special protocol
assessment (SPA) agreement with the U.S. Food and Drug
Administration (FDA), if the primary endpoint is met, Ranexa could
potentially be approved for treatment of ACS and secondary
prevention. In addition, if treatment with Ranexa in this study is
not associated with an adverse trend in death or arrhythmia
compared to placebo, under the SPA agreement, the study's safety
database could support potential approval of Ranexa as first-line
chronic angina therapy, even if the primary endpoint is not met,
according to the SPA. "The MERLIN TIMI-36 study represents the most
comprehensive clinical trial ever conducted with Ranexa and has the
potential to provide new indications for first-line use in chronic
angina and ACS," said Louis G. Lange, M.D., Ph.D., chairman and
chief executive officer of CV Therapeutics. "There is the potential
for this outcomes study to provide information to physicians that
could impact the quality of care for millions of patients with
ischemic heart disease." Study Details 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. Acute Coronary Syndromes
Patients with acute coronary syndromes (ACS) present with either
acute myocardial infarction or unstable angina. According to the
American Heart Association, there were more than 1.5 million
hospital discharges for ACS in 2003. Most ACS patients typically
fall into one of three categories: ST elevation myocardial
infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI)
or unstable angina. 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 6.5 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 products include RanexaP(R) (ranolazine
extended-release tablets) and ACEONP(R) (perindopril erbumine)
Tablets. 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. In addition, CV Therapeutics
co-promotes ACEONP(R), an ACE inhibitor, for reduction of the risk
of cardiovascular mortality or nonfatal myocardial infarction in
patients with stable coronary artery disease and treatment of
essential hypertension. 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.
Regadenoson has not been approved for marketing by any regulatory
authorities. Except for the historical information contained
herein, the matters set forth in this press release 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 regulatory review and approval of our products; special
protocol assessment agreement; the conduct, timing and results of
clinical trials, including the MERLIN TIMI-36 study;
commercialization of products; market acceptance of products;
product labeling; 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, 2006. CV Therapeutics disclaims
any intent or obligation to update these forward-looking
statements. DATASOURCE: CV Therapeutics, Inc. CONTACT: investors,
Christopher Chai of Vice President, Treasury and Investor
Relations, +1-650-384-8560, or media, John Bluth, Senior Director,
Corporate Communications, +1-650-384-8850, both of CV Therapeutics,
Inc. Web site: http://www.cvt.com/
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