CV Therapeutics Identifies Potential Anti-Diabetic Mechanism of Action for Ranexa(R)
July 09 2007 - 4:01PM
PR Newswire (US)
-- New preclinical information may correlate with clinical HbA1c
reductions observed in Phase 3 CARISA and MERLIN TIMI-36 clinical
trials -- PALO ALTO, Calif., July 9 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that researchers
have completed preliminary preclinical studies showing that
ranolazine increased glucose stimulated insulin secretion in
pancreatic beta cells. In separate experiments using preclinical
models of insulin resistance, ranolazine also improved glucose
homeostasis. These data could illustrate an underlying first in
class mechanism of action for the statistically significant
reductions in HbA1c levels observed with Ranexa in cardiovascular
patients with diabetes from the phase 3 CARISA (n=189 with angina
and diabetes) and MERLIN TIMI-36 (n=2,220 with acute coronary
syndromes and diabetes) clinical trials. In CARISA (Combination
Assessment of Ranolazine in Stable Angina), Ranexa (ranolazine
extended release tablets) reduced HbA1c levels by an average of up
to 0.7 percentage points in angina patients with diabetes. The
reduction in HbA1c was not associated with increased hypoglycemia.
"Preclinical studies have shown that Ranexa inhibits the late
sodium current in cardiac cells. Potentially, the sodium channels
present in pancreatic beta cells may play a role in the secretion
of insulin," said Luiz Belardinelli, M.D., senior vice president of
pharmacological translational and biomedical research and a
distinguished fellow of cardiovascular science at CV Therapeutics.
The company plans to submit data from these new preclinical
experiments for publication later this year. 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 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, 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;
dependence on Ranexa; special protocol assessment agreement for
Ranexa; the conduct and timing of clinical trials;
commercialization of products; market acceptance of products;
product labeling; concentrated customer base; and other risks
detailed from time to time in CV Therapeutics' SEC reports,
including its Annual Report on Form 10-Q for the quarter ended
March 31, 2007. CV Therapeutics disclaims any intent or obligation
to update these forward-looking statements. DATASOURCE: CV
Therapeutics, Inc. CONTACT: John Bluth, Senior Director, Corporate
Communications & Investor Relations of CV Therapeutics, Inc.,
+1-650-384-8850 Web site: http://www.cvt.com/
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