CV Therapeutics Initiates MERLIN TIMI-36 Study of Ranexa(TM)
October 11 2004 - 8:00AM
PR Newswire (US)
CV Therapeutics Initiates MERLIN TIMI-36 Study of Ranexa(TM) PALO
ALTO, Calif., Oct. 11 /PRNewswire-FirstCall/ -- CV Therapeutics,
Inc. (NASDAQ:CVTX) announced today that it has initiated enrollment
in the MERLIN (Metabolic Efficiency with Ranolazine for Less
Ischemia in Non-ST Elevation Acute Coronary Syndromes) TIMI-36
study of Ranexa. MERLIN TIMI-36 is being conducted under the U.S.
Food and Drug Administration's (FDA) special protocol assessment
(SPA) process, and if successful, could support approval of Ranexa
as first-line therapy for patients suffering from chronic angina.
This study could also result in approval for treatment of acute
coronary syndromes (ACS) and for long-term prevention of ACS. 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. "We are
very pleased to begin enrollment in this important study, which
could bring us closer to our goal of commercializing Ranexa for a
broad population of patients with ischemic conditions such as
angina," said Louis G. Lange, M.D., Ph.D., chairman and chief
executive officer of CV Therapeutics, Inc. If approved, Ranexa
would represent the first new class of anti-anginal therapy in the
United States in more than 25 years. 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. It affects approximately 6.8 million people
in the United States. 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 5,500 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. Under the SPA
agreement, if statistical significance on the primary endpoint is
achieved, Ranexa could gain approval for hospital-based treatment
of ACS and for long-term prevention of ACS in patients that present
at the hospital with ACS and are treated and discharged.
Importantly, under the same SPA agreement, if treatment with Ranexa
is not associated with an adverse trend in death or arrhythmia
compared to placebo, the large 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. As part of this SPA agreement, CV Therapeutics also has
committed to perform a separate clinical evaluation of higher doses
of Ranexa to support potential use as first-line therapy for
chronic angina. The study's duration will be event driven. It 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. Approximately 600 study sites
worldwide are expected to enroll patients. Based on historical
clinical trial information from the TIMI Study Group, preliminary
data could be available by the end of 2006. The SPA process creates
a binding written agreement between the sponsoring company and the
FDA concerning clinical trial design, clinical endpoints, study
conduct, data analysis and other clinical trial issues. It is
intended to provide assurance that if pre-specified trial results
are achieved, they may serve as the primary basis for an efficacy
claim in support of a new drug application (NDA). In general, these
assessments are considered binding on the FDA as well as the
sponsor unless public health concerns unrecognized at the time the
SPA is entered into become evident or other new scientific concerns
regarding product safety or efficacy arise. 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 currently has four compounds in clinical development.
CV Therapeutics has received an approvable letter from the FDA
relating to its NDA for Ranexa for the potential treatment of
chronic angina, and has submitted an application for the approval
of ranolazine for the potential treatment of chronic angina to the
European Medicines Agency. Regadenoson, a selective A2A-adenosine
receptor agonist, is being developed for potential use as a
pharmacologic stress agent in cardiac perfusion imaging studies.
Tecadenoson, an A1-adenosine receptor agonist, is being developed
for the potential reduction of rapid heart rate during atrial
arrhythmias. Adentri(TM), an A1-adenosine receptor antagonist for
the potential treatment of heart failure, is being developed by
Biogen Idec Inc. For more information, please visit CV
Therapeutics' website at http://www.cvt.com/. CV Therapeutics is a
development-stage company. None of the Company's products have been
approved for marketing by the FDA or any foreign regulatory
authorities. Any products of the Company discussed here are
currently under investigation in clinical trials subject to United
States Investigational New Drug applications, and as applicable,
appropriate clinical trial applications to regulatory authorities
outside the United States. Except for the historical information
contained herein, the matters set forth in this press release,
including statements as to development, regulatory review, and
commercialization of the company's products, and the conduct and
timing of clinical trials, 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; the dependence on
collaborative and licensing agreements; commercialization of our
products; and other risks detailed from time to time in CVT's SEC
reports, including its most recent Annual Report on Form 10-K, and
its most recent Quarterly Report on Form 10-Q. CVT disclaims any
intent or obligation to update these forward-looking statements.
DATASOURCE: CV Therapeutics, Inc. CONTACT: investors, Dan
Spiegelman, SVP & Chief Financial Officer, +1-650-384-8509, or
Christopher Chai, Treasurer & Executive Director, Investor
Relations, +1-650-384-8560, or media, John Bluth, Senior Director,
Corporate Communications, +1-650-384-8850, all of CV Therapeutics,
Inc.; or Carol Harrison of Fleishman-Hillard, +1-212-453-2442, for
CV Therapeutics, Inc. Web site: http://www.cvt.com/
Copyright
CV Therapeutics (NASDAQ:CVTX)
Historical Stock Chart
From Jun 2024 to Jul 2024
CV Therapeutics (NASDAQ:CVTX)
Historical Stock Chart
From Jul 2023 to Jul 2024