Circulation Publishes Study of Ranolazine Demonstrating Important Cardiac Ion Channel Effects
August 24 2004 - 8:00AM
PR Newswire (US)
Circulation Publishes Study of Ranolazine Demonstrating Important
Cardiac Ion Channel Effects PALO ALTO, Calif., Aug. 24
/PRNewswire-FirstCall/ -- In a preclinical study published in
today's issue of the journal Circulation, researchers concluded
that potentially anti-arrhythmic effects observed with ranolazine
may be due to the ability of ranolazine to inhibit the late sodium
current. The effect of ranolazine on the late sodium current could
be relevant to the drug's potential to treat a variety of
cardiovascular conditions, including chronic angina and acute
coronary syndromes (ACS). The research team, led by Charles
Antzelevitch, Ph.D., executive director and director of research at
Masonic Medical Laboratory in Utica, New York, recorded the effects
of ranolazine on ion current channels in animal heart cells at drug
concentrations ranging from 0.5 uM to 100 uM. Therapeutic
concentrations of ranolazine (2 uM to 6 uM) suppressed early
afterdepolarizations and reduced dispersion, two important
predictors of a drug's anti-arrhythmic potential. The plasma
concentrations of ranolazine studied in prior clinical trials
generally ranged from 1 uM to 10 uM. Outside investigators, in
conjunction with scientists at CV Therapeutics, Inc. (NASDAQ:CVTX),
have conducted a series of studies to evaluate the effects of
ranolazine on cardiac ion channels, such as the late sodium
channel. "This study extends and validates previous work by other
investigators and laboratories demonstrating that ranolazine
inhibits the late sodium current, which could contribute to the
anti-ischemic and anti-anginal activity observed with ranolazine in
clinical trials, and provides the basis for further study of other
cardiovascular conditions," said Louis G. Lange, M.D., Ph.D.,
chairman and chief executive officer of CV Therapeutics. Abnormal
increases in the late sodium current are believed to be associated
with several congenital and acquired cardiovascular diseases,
including ischemia (angina, ACS), chronic heart failure (CHF) and
variants of long QT syndrome. "Under conditions of ischemia such as
angina and ACS, and with mechanical dysfunctions of the heart such
as CHF, the late sodium current is increased, so a drug that
inhibits this current could have anti-ischemic activity and could
also theoretically have anti-arrhythmic activity. These potential
benefits will need to be explored with future clinical evaluation,"
said Victor J. Dzau, M.D., chancellor for health affairs at Duke
University and a member of the CV Therapeutics scientific advisory
board. In addition to the study published today in Circulation, the
following studies have also recently been published: -- Song Y,
Shryock JC, Wu L, Belardinelli L. Antagonism by Ranolazine of the
Pro-Arrhythmic Effects of Increasing Late INa in Guinea Pig
Ventricular Myocytes., J Cardiovasc Pharmacol. 2004;
Aug;44(2):192-199 -- Undrovinas AI, Undrovinas NA, Belardinelli L,
Sabbah HN. Ranolazine Inhibits Late Sodium Current in Isolated Left
Ventricular Myocytes of Dogs With Heart Failure., J Am Coll
Cardiol. 2004;43(suppl A):178A. Abstract 1068-128 -- Wu L, Shryock
JC, Song Y, Li Y, Antzelevitch C, Belardinelli L. Anti-Arrhythmic
Effects of Ranolazine in a Guinea Pig in Vitro Model of Long-QT
Syndrome., J Pharmacol Exp Ther. 2004;Aug;310(2):599-605 If
approved, Ranexa(TM) (ranolazine) 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. CV Therapeutics is a development-stage company. None of the
company's products have been approved for marketing by the United
States Food and Drug Administration (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. 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 new drug application 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/. 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,
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/
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