CV Therapeutics Completes Enrollment of Second Regadenoson Phase 3 Trial
June 07 2006 - 8:00AM
PR Newswire (US)
PALO ALTO, Calif., June 7 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. (NASDAQ:CVTX) announced today that patient
enrollment of the second Phase 3 trial of regadenoson has been
completed. The company expects topline data from the trial could be
available in the second half of 2006. In this trial, patients 18
years or older with the clinical need for a pharmacologic stress
myocardial perfusion imaging (MPI) study were eligible to
participate. Individuals who had an acute myocardial infarction or
unstable angina within three months, or coronary revascularization
within six months, were not permitted to participate in the study.
All study participants received a clinically indicated baseline MPI
study using Adenoscan(R) (adenosine injection). Participants then
were randomized in a double blinded fashion to receive either
regadenoson or Adenoscan in a second MPI study. Each patient's scan
is classified as indicating normal, moderate or severe ischemia.
Baseline and blinded scans then are evaluated to determine if the
scans are comparable. Adenoscan is the leading agent for MPI
studies in the United States and is marketed by Astellas Pharma US,
Inc. First Regadenoson Phase 3 Trial Data from the first Phase 3
trial of regadenoson, with an identical study design, were
presented as a late breaking clinical trial at the American Society
of Nuclear Cardiology Scientific Sessions 2005. The first Phase 3
trial met its primary endpoint by showing with 95 percent
confidence that MPI studies conducted with regadenoson were
comparable to MPI studies conducted with Adenoscan. In the first
Phase 3 trial, regadenoson was generally well tolerated and the
most common adverse events reported in patients who received
regadenoson were headache, chest pain, shortness of breath,
flushing and gastrointestinal discomfort. About Regadenoson
Regadenoson is a selective A2A-adenosine receptor agonist for
potential use as a pharmacologic stress agent in MPI studies.
Regadenoson has been designed to be delivered rapidly as a bolus
and to selectively stimulate the A2A-adenosine receptor, the
receptor responsible for coronary vasodilation. Regadenoson has not
been approved for marketing by any regulatory authorities. Under a
collaboration agreement providing Astellas with exclusive North
American rights to regadenoson, CV Therapeutics manages the
clinical development program and Astellas is responsible for
manufacturing, selling and marketing regadenoson in North America,
if the product is approved for marketing. Under the arrangement,
Astellas reimburses CV Therapeutics for 75 percent of development
costs and CV Therapeutics will receive a royalty on product sales
of regadenoson, if approved, and may receive a royalty on another
product. CV Therapeutics owns the rights for regadenoson outside of
North America. 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 the 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 stress 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 stress 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'
approved products include Ranexa(R) (ranolazine extended- release
tablets) and ACEON(R) (perindopril erbumine) Tablets. Ranexa 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. In addition, CV Therapeutics co-promotes ACEON(R), an ACE
inhibitor, for reduction of the risk of cardiovascular mortality or
nonfatal myocardial infarction in patients with stable coronary
artery disease and treatment of essential hypertension. 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. Regadenoson has 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, conduct of clinical studies, study results, regulatory
review and approval, 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; commercialization of products; market acceptance of
products; product labeling; 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 March 31, 2006. 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/
Copyright
CV Therapeutics (NASDAQ:CVTX)
Historical Stock Chart
From Jul 2024 to Aug 2024
CV Therapeutics (NASDAQ:CVTX)
Historical Stock Chart
From Aug 2023 to Aug 2024