CV Therapeutics Announces MERLIN TIMI-36 Study to Continue as Planned Based on Interim Analysis
February 09 2006 - 7:00AM
PR Newswire (US)
PALO ALTO, Calif., Feb. 9 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that the MERLIN
(Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST
Elevation Acute Coronary Syndromes) TIMI-36 study of Ranexa(TM)
(ranolazine extended-release tablets) will continue as planned
based on the results of an interim efficacy analysis. As specified
in the MERLIN TIMI-36 study protocol, the independent Data Safety
Monitoring Board (DSMB) overseeing the study conducted an interim
efficacy analysis as well as a periodic safety assessment when
approximately half of the anticipated major cardiovascular events
occurred. A statistically significant drug treatment effect on the
rate of cardiovascular death with a p-value of less than 0.001 was
pre-specified as being required for the DSMB to consider a
recommendation to stop the study early. The Company has been
informed that the DSMB recommended that the study continue as
planned. Preliminary study results for the MERLIN TIMI-36 study
could be available in the fourth quarter of 2006 or the first
quarter of 2007. "After the recent FDA approval of Ranexa, the
MERLIN TIMI-36 study is an important study to potentially expand
the indication. We are excited that the study will continue, as we
expected it would, and we look forward to meeting our next
milestone, which is completion of patient enrollment," said Louis
G. Lange, M.D., Ph.D., chairman and chief executive officer of CV
Therapeutics, Inc. On January 27, 2006, the U.S. Food and Drug
Administration (FDA) approved Ranexa for the treatment of chronic
angina. Because Ranexa prolongs the QT interval, it should be
reserved for patients who have not achieved an adequate response
with other antianginal drugs. Ranexa should be used in combination
with amlodipine, beta-blockers or nitrates. The effect on angina
rate or exercise tolerance appeared to be smaller in women than
men. The approval of Ranexa marked the first new pharmaceutical
approach to treat angina in more than 20 years in the United
States. CV Therapeutics anticipates that Ranexa will be available
in pharmacies in late March. Complete prescribing information for
Ranexa, including detailed safety and dosage information, is
available at http://www.cvt.com/. MERLIN TIMI-36 is being conducted
under the FDA's special protocol assessment (SPA) process. Under
the SPA agreement, if treatment with Ranexa 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 statistical
significance on the primary endpoint is not achieved, provided that
we also complete successfully an ongoing clinical evaluation of
higher Ranexa doses. Importantly, under the same MERLIN TIMI-36 SPA
agreement, if statistical significance on the primary endpoint is
achieved, Ranexa could gain approval for hospital-based treatment
of acute coronary syndromes (ACS) and for long- term prevention of
ACS in patients that present at the hospital with ACS and are
treated and discharged. 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. Study Summary 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 during acute and long-term treatment in
approximately 6,500 patients with non-ST elevation acute coronary
syndromes 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 oral Ranexa 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 Phase 3 clinical trials. The study's
duration is event driven. 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. 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(TM) (ranolazine extended-release tablets) and
ACEON(R) (perindopril erbumine) Tablets. Ranexa is indicated for
the treatment of chronic angina. Because Ranexa prolongs the QT
interval, it should be reserved for patients who have not achieved
an adequate response with other antianginal drugs. Ranexa should be
used in combination with amlodipine, beta-blockers or nitrates. The
effect on angina rate or exercise tolerance appeared to be smaller
in women than men. 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, clinical studies, special protocol
assessment agreements, 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; 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, 2005. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements. FCMN Contact: andrea.campbell@cvt.com
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 Web site:
http://www.cvt.com/
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