Ranexa(R) Significantly Reduces Incidence of CV Death, MI or Recurrent Ischemia in MERLIN TIMI-36 Patients With Elevated BNP
November 05 2007 - 10:00AM
PR Newswire (US)
ORLANDO, Fla., Nov. 5 /PRNewswire-FirstCall/ -- CV Therapeutics,
Inc. (NASDAQ:CVTX) announced today that Ranexa(R) (ranolazine
extended-release tablets) reduced the relative risk of the primary
composite endpoint of CV death, myocardial infarction or recurrent
ischemia by 21 percent compared to placebo in 1,935 patients with
an elevated (>80pg/ml) level of b-type natriuretic peptide (BNP)
in the MERLIN TIMI-36 study (p=0.009). The data were presented
today by Dr. David Morrow of the TIMI Study Group at the American
Heart Association Scientific Sessions in Orlando, Florida.
Ranolazine is believed to exert its anti-ischemic effects through
ion channel activity which may ultimately reduce left ventricular
(LV) wall stress and improve diastolic dysfunction. BNP rises in
response to LV wall stress and is a potent indicator of risk in
acute coronary syndromes (ACS). "The potential enhanced efficacy of
ranolazine in patients with elevated BNP in this analysis is
consistent with the drug's mechanism of action. Elevated BNP is
among the most powerful indicators of risk for ACS patients, and it
is very intriguing to see the potentially beneficial effects of
ranolazine in this group of MERLIN TIMI-36 patients," Morrow said.
"Few interventions have been shown to modify the risk associated
with increased BNP. This finding warrants prospective
confirmation," he added. 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: Investors and Media, 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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