CV Therapeutics Initiates Second Phase III Trial of Regadenoson
April 26 2004 - 8:00AM
PR Newswire (US)
CV Therapeutics Initiates Second Phase III Trial of Regadenoson
PALO ALTO, Calif., April 26 /PRNewswire-FirstCall/ -- CV
Therapeutics, Inc. announced today that it has initiated a second
Phase III clinical trial of regadenoson (CVT-3146). Regadenoson is
a selective A2A-adenosine receptor agonist being jointly developed
with Fujisawa Healthcare, Inc. (Fujisawa) for potential use as a
pharmacologic stress agent in cardiac perfusion imaging studies.
This is the second double-blind international Phase III trial of
regadenoson in patients undergoing a cardiac stress test. The first
Phase III trial was initiated in October 2003. "We are very pleased
to initiate this second Phase III trial. Our objective is to submit
a new drug application (NDA) to the U.S. Food and Drug
Administration (FDA) as quickly as possible. If approved, our
partner Fujisawa, a leader in the cardiac stress imaging
marketplace, will be responsible for the commercialization of
regadenoson in the United States," said Louis G. Lange, M.D.,
Ph.D., chairman and chief executive officer of CV Therapeutics,
Inc. Cardiac perfusion imaging studies Cardiac perfusion imaging
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 cardiac perfusion
imaging studies in the United States. Many patients exercise on a
treadmill to generate the increase in coronary blood flow necessary
to perform a cardiac perfusion imaging test. However, more than 40
percent of the patients undergoing a cardiac perfusion imaging test
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. 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.
Current pharmacologic stress agents, which are not selective for
the A2A-adenosine receptor, may cause unwanted physiological side
effects. Under a collaboration agreement providing Fujisawa with
exclusive North American rights to regadenoson, CV Therapeutics
manages the clinical development program and Fujisawa will be
responsible for manufacturing, selling and marketing regadenoson in
North America, if the product is approved for marketing. Under the
arrangement, Fujisawa 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. In an open label Phase II trial,
regadenoson produced a dose-dependent increase in coronary blood
flow velocity in patients undergoing cardiac catheterization.
Regadenoson was generally well-tolerated, and drug-related adverse
events, including chest discomfort, increased heart rate,
hypotension, flushing and shortness of breath, were mild and
self-limited. Regadenoson has not been approved for marketing by
the FDA or foreign regulatory authorities. Regadenoson presently is
being investigated in clinical trials subject to a United States
investigational new drug application and applicable foreign
regulatory submissions. CV Therapeutics has not yet submitted a new
drug application to the FDA or equivalent application to any
foreign regulatory authority for regadenoson. Neither the FDA or
any foreign regulatory authority have determined regadenoson to be
safe or effective in humans for any use. CV Therapeutics, Inc. 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.
Applications for the approval of ranolazine for the treatment of
chronic angina have been submitted to the United States Food and
Drug Administration (FDA) and the European Agency for the
Evaluation of Medicinal Products (EMEA). 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 congestive heart failure,
is licensed to Biogen, Inc. (now Biogen Idec Inc.). For more
information, please visit CV Therapeutics' website at
http://www.cvt.com/. CV Therapeutics is a development-stage
company. None of the company's products have been approved for
marketing by the FDA, the EMEA or any other 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. Fujisawa Healthcare, Inc. Fujisawa
Healthcare, Inc., headquartered in Deerfield, Illinois, develops,
manufactures and markets proprietary pharmaceutical products in the
United States. Fujisawa Healthcare, Inc., is a subsidiary of
Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan. Fujisawa
Pharmaceutical Co., Ltd., founded in 1894, is a leading
pharmaceutical manufacturer with operations in North America,
Europe and Asia. Additional information on Fujisawa Healthcare,
Inc., and its products can be found on the company's web site at
http://www.fujisawa.com/ . Except for the historical information
contained herein, the matters set forth in this press release,
including statements as to development 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 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: Dan Spiegelman, SVP & Chief
Financial Officer, +1-650-384-8509, or investors, media, John
Bluth, Senior Director, Corporate Communications, +1-650-384-8850,
both of CV Therapeutics, Inc.; or Carol Harrison, +1-212-453-2442,
or Christopher Chai, Treasurer & Executive Director, Investor
Relations, +1-650-384-8560, both of Fleishman-Hillard, for CV
Therapeutics, Inc. Web site: http://www.fujisawa.com/ Web site:
http://www.cvt.com/
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