Ranexa(R) Significantly Reduces Ischemia in Women in MERLIN TIMI-36 Study
November 06 2007 - 10:00AM
PR Newswire (US)
ORLANDO, Fla., Nov. 6 /PRNewswire-FirstCall/ -- CV Therapeutics,
Inc. (NASDAQ:CVTX) announced today that an analysis of data from
2,291 women who participated in the MERLIN TIMI-36 study showed a
29 percent reduction in the relative risk of recurrent ischemia in
women receiving Ranexa(R) (ranolazine extended-release tablets)
compared to placebo (p=0.002) after 12 months. No difference in
symptomatic documented arrhythmias was observed in women between
the ranolazine and placebo groups. The data were presented today by
Dr. Jessica Mega of the TIMI Study Group at the American Heart
Association Scientific Sessions in Orlando, Florida. "Women were
very well represented in the MERLIN TIMI-36 study and these data
provide important additional confirmation of the safety and
efficacy we have seen with Ranexa in other clinical trials and in
commercial use," said Louis G. Lange, CV Therapeutics chairman and
chief executive officer. According to the American Heart
Association, cardiovascular disease is the leading cause of death
among American women. In accordance with a special protocol
assessment agreement between the U.S. Food and Drug Administration
(FDA) and CV Therapeutics, the Company believes that data from the
MERLIN TIMI-36 study could support expansion of the existing Ranexa
indication to first line angina. In September 2007, the Company
submitted a supplemental new drug application to the FDA seeking a
new indication for first line angina and a significant reduction in
cautionary language. Ranexa is currently 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. Study
Design MERLIN TIMI-36 (Metabolic Efficiency with Ranolazine for
Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) was 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 6,560
patients (3,279 received ranolazine, 3,281 received placebo) 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. Participants in the MERLIN TIMI-36 study received current
standard therapy, with approximately 96 percent of patients on
aspirin, approximately 89 percent on beta blockers and
approximately 82 percent on statins. Approximately 59 percent of
study participants received coronary angiography during their
initial hospitalization. Previously published data from the MERLIN
TIMI-36 study has shown that Ranexa was safe in this population of
patients with coronary artery disease, which included nearly 1,100
patients with prior heart failure. 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 product, Ranexa(R) (ranolazine
extended-release tablets), 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. CV
Therapeutics' clinical and preclinical drug development candidates
and programs include regadenoson, which is being developed for
potential use as a pharmacologic stress agent in myocardial
perfusion imaging studies, and CVT-6883, which is being developed
as a potential treatment for cardiopulmonary diseases. Regadenoson
and CVT-6883 have not been determined by any regulatory authorities
to be safe or effective in humans for any use. 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 operating losses and fluctuations in
operating results; capital requirements; regulatory review and
approval of our products; special protocol assessment agreement;
the conduct and timing of clinical trials; commercialization of
products; market acceptance of products; product labeling;
concentrated customer base; reliance on strategic partnerships and
collaborations; uncertainties in drug development; uncertainties
regarding intellectual property; 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, 2007. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements. DATASOURCE: CV Therapeutics, Inc.
CONTACT: John Bluth, Executive Director, Corporate Communications
& Investor Relations, of CV Therapeutics, Inc., +1-650-384-8850
Web site: http://www.cvt.com/
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