Data From Regadenoson Phase 3 Study to Be Presented as Late Breaker at American Society of Nuclear Cardiology Scientific Session
August 29 2005 - 8:00AM
PR Newswire (US)
PALO ALTO, Calif., Aug. 29 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) today announced that data from the
first completed Phase 3 study of regadenoson will be presented as a
Late Breaking Clinical Trial at the American Society of Nuclear
Cardiology Scientific Sessions 2005 on Sunday, October 2 in
Seattle. This multinational, randomized, double-blind, pivotal
Phase 3 study met its primary endpoint by showing with 95 percent
confidence that myocardial perfusion imaging (MPI) studies
conducted with regadenoson were comparable to MPI studies conducted
with Adenoscan(R). Adenoscan(R) is the leading agent for MPI
studies in the United States and is marketed by Astellas Pharma US,
Inc. Myocardial perfusion imaging studies MPI studies help detect
and characterize coronary artery disease by identifying areas of
poor blood flow in the heart. In 2002, approximately 7.8 million
patients underwent MPI studies in the United States. Many patients
exercise on a treadmill to generate the increase in coronary blood
flow necessary to perform an MPI study. However, more than 40
percent of patients undergoing an MPI study are unable to exercise
adequately because of medical conditions such as peripheral
vascular disease, arthritis or other limiting medical conditions
which prevent them from exercising on the treadmill. For these
patients, a pharmacologic agent that temporarily increases coronary
blood flow is used to mimic the increase in coronary blood flow
caused by exercise. Regadenoson is being studied for potential use
as a pharmacologic agent under these circumstances. 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 three
programs in commercial or late-stage development: ACEON(R)
(perindopril erbumine) Tablets, Ranexa(TM) (ranolazine) and
regadenoson. CV Therapeutics also has other clinical and
preclinical drug development candidates and programs. The company
co-promotes ACEON(R), an ACE inhibitor with enhanced tissue
affinity, for the treatment of essential hypertension and reduction
of the risk of cardiovascular mortality or non- fatal myocardial
infarction in patients with stable coronary artery disease. Ranexa
is being developed as a novel potential treatment for chronic
angina. Regadenoson is being developed for potential use as a
pharmacologic stress agent in myocardial perfusion imaging studies.
Ranexa and regadenoson have not been approved for marketing by any
regulatory authorities. Except for the historical information
contained herein, the matters set forth in this press release,
including statements as to development, clinical studies,
regulatory review, and commercialization of 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 products; 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, 2005. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements. DATASOURCE: CV Therapeutics, Inc.
CONTACT: investors, Christopher Chai, Vice President, Treasury and
Investor Relations, +1-650-384-8560, or media, John Bluth, Senior
Director, Corporate Communications, +1-650-384-8850, both of CV
Therapeutics, Inc. Web site: http://www.cvt.com/
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