JCI Publishes Preclinical Study Evaluating Potential Ability of CVT-6883 for the Treatment of Pulmonary Conditions
August 01 2006 - 8:00AM
PR Newswire (US)
Study Assessed Pulmonary Inflammation, Fibrosis and Other Potential
Markers of Pulmonary Diseases PALO ALTO, Calif., Aug. 1
/PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX)
announced today that the Journal of Clinical Investigation (JCI)
has published a preclinical study suggesting that CVT-6883
significantly reduced elevated markers of inflammation, fibrosis
and pulmonary injury in two separate in vivo models. CVT-6883 is a
selective, potent and orally available A2B-adenosine receptor
antagonist which CV Therapeutics is investigating for the potential
treatment of asthma and other conditions related to inflammation
and fibrosis. An initial Phase 1 study of CVT-6883 has been
completed. In this randomized, double-blind, placebo-controlled,
single ascending dose study in 24 healthy volunteers, CVT-6883 was
well tolerated with no serious adverse events reported. In the
preclinical study described in JCI, mice predisposed to elevated
adenosine levels developed pulmonary inflammation, fibrosis and
enlargement of air sacs in the lungs called alveolar spaces.
Treatment with CVT-6883 reduced these conditions and also
significantly reduced elevations in proinflammatory cytokines and
chemokines. In a separate in vivo model, CVT-6883 also inhibited
pulmonary inflammation and fibrosis induced by bleomycin. "These in
vivo models exhibit many of the characteristics typical of patients
with chronic lung disease and asthma, so the results support the
scientific rationale for treating asthma and other conditions
related to inflammation and fibrosis with a selective A2B-adenosine
receptor antagonist," said Michael Blackburn, Ph.D., professor of
biochemistry and molecular biology at the University of Texas
Medical School at Houston and corresponding author of the study.
About Asthma Asthma is a chronic lung disease characterized by
recurrent episodes of wheezing, breathlessness, chest tightness and
coughing. Pulmonary inflammation contributes to the
bronchoconstriction that can precipitate an asthma attack and to
the progression of this chronic disease. In 2002, 20 million people
in the United States had asthma, according to the American Lung
Association. The National Heart Lung and Blood Institute notes that
asthma accounts for $16.1 billion in direct and indirect healthcare
costs annually. In asthma, increased levels of adenosine can
overactivate the A2B- adenosine receptor leading to mast cell
degranulation and the release of inflammatory cytokines associated
with bronchoconstriction and chronic lung inflammation. CVT-6883
may provide a potentially novel approach to preventing or reducing
this inflammatory process by selectively inhibiting the A2B-
adenosine receptor. 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 and CVT-6883, which
is being developed as a potential treatment for asthma and other
conditions. 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, including statements
as to development, conduct of clinical studies, and study results,
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/
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