CV Therapeutics Announces Completion of MERLIN TIMI-36 Enrollment
May 25 2006 - 8:00AM
PR Newswire (US)
PALO ALTO, Calif., May 25 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that patient
enrollment in the MERLIN TIMI-36 study of ranolazine is now
complete, with over 6,500 patients enrolled. The company expects
top line data from the study could be available in the first
quarter of 2007. According to a special protocol assessment (SPA)
agreement with the U.S. Food and Drug Administration (FDA), if
treatment with Ranexa(R) (ranolazine extended-release tablets) in
this study is not associated with an adverse trend in death or
arrhythmia compared to placebo, 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. In addition, if
the primary endpoint is met, Ranexa could potentially also be
approved for treatment of acute coronary syndromes (ACS) and
secondary prevention. "We are extremely pleased to have reached a
significant landmark for this important clinical trial and
appreciate the hard work of all of the MERLIN-TIMI 36 investigators
and research coordinators worldwide," said Eugene Braunwald, M.D.,
distinguished Hersey Professor of Medicine, Harvard Medical School,
Chairman, TIMI Study Group Brigham and Women's Hospital. 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. The primary efficacy endpoint in MERLIN TIMI-36
is time to first occurrence of any element of the composite of
cardiovascular death, myocardial infarction or recurrent ischemia
in patients with non-ST elevation ACS receiving standard therapy.
The study also evaluates the safety of long-term treatment with
Ranexa compared to placebo. Within 48 hours of the onset of angina
due to ACS, eligible hospitalized patients are 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 receive
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. The completion of MERLIN TIMI-36 is based on achieving
specific numbers of events. The trial is expected to continue until
a pre-specified number of cases of cardiovascular death, myocardial
infarction or severe recurrent ischemia have been observed, and a
pre-determined number of deaths from any cause have occurred.
Slower than anticipated event rates could delay our schedule for
trial completion and results. 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 Ranexa(R) (ranolazine
extended-release tablets) and ACEON(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 ACEON(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, including
statements as to special protocol assessment agreements, conduct of
clinical studies, study results, regulatory review and approval 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, early stage of
development; regulatory review and approval of our products;
special protocol assessment agreements; 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 Quarterly Report on Form 10-Q for the
quarter ended March 31, 2006. CV Therapeutics disclaims any intent
or obligation to update these forward-looking statements.
DATASOURCE: CV Therapeutics, Inc. CONTACT: Christopher Chai, 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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