CV Therapeutics, Inc.
(Nasdaq: CVTX) announced 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.
CV Therapeutics, Inc.
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View drug information on Ranexa.