MERLIN TIMI-36 Study Design Published in American Heart Journal
June 21 2006 - 8:00AM
PR Newswire (US)
Long-term outcomes evaluated for safety and efficacy in ischemic
patients PALO ALTO, Calif., June 21 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that the American
Heart Journal (AHJ) has published the study design and rationale
for the MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for
Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) trial.
This multi-site study completed patient enrollment in May 2006 and
the company expects that top line data from the study could be
available in the first quarter of 2007. 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. MERLIN TIMI-36 is a
multi-national, double-blind, randomized, placebo- controlled,
parallel-group clinical trial designed to evaluate the efficacy and
safety of Ranexa(R) (ranolazine extended-release tablets) during
acute and long-term treatment in approximately 6,500 patients with
non-ST elevation acute coronary syndromes (ACS) treated with
standard therapy. 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 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 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 receive
standard therapy during both hospital-based and outpatient
treatment. The oral doses of Ranexa used in MERLIN TIMI-36 have
been studied in previous clinical trials. "The MERLIN TIMI-36 is
the largest study ever conducted with ranolazine and will provide
important new information for physicians and patients to consider
about the potential utility of a new pharmaceutical approach to
treating patients with ischemic heart disease," said lead author
David Morrow M.D., MPH, Cardiovascular Division/TIMI Study Group,
Brigham and Women's Hospital, Harvard Medical School. The study
investigators note in the paper that, "through the inhibition of
the late cardiac sodium current, ranolazine may reduce the
deleterious effects associated with intracellular sodium and
calcium overload that accompany myocardial ischemia." The product
labeling for Ranexa states that the mechanism of action is unknown.
Major Substudies and Analyses The publication outlines several
prospectively planned substudies designed to provide mechanistic
and prognostic information and to assess the impact of ranolazine
on quality of life and resource utilization. An economic quality of
life (EQOL) substudy is designed to compare EQOL outcomes in
patients randomized to either ranolazine or placebo over a one-year
period. A biomarker substudy will principally assess the impact of
ranolazine on sensitive biomarkers of necrosis, ischemia and
hemodynamic stress as noninvasive indicators of the extent and
severity of myocardial injury as well as myocardial performance.
Several study centers also are collecting blood samples from
consenting study participants to isolate DNA for a genetic
substudy. An echocardiographic substudy will evaluate whether the
effects of ranolazine on left ventricular systolic and diastolic
function observed in animal models are apparent in patients with
acute ischemic heart disease. The MERLIN TIMI-36 study includes
planned assessments of diabetes in patients with ischemic heart
disease. The study also will assess outcomes among these patients,
and the influence of ranolazine on these outcomes. The MERLIN
TIMI-36 study design was published online by AHJ and is expected to
be included in a future print edition of the journal. According to
a special protocol assessment (SPA) agreement with the U.S. Food
and Drug Administration (FDA), if treatment with Ranexa in the
MERLIN TIMI-36 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 ACS and secondary prevention. 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. Trial completion and
results may be affected by slower than anticipated event rates.
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 development, conduct of
clinical studies, study results, regulatory review and approval,
special protocol assessments 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; the conduct and timing of clinical
trials; 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 March 31, 2006. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements. DATASOURCE: CV Therapeutics, Inc.
CONTACT: investors, 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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