Data from Completed Phase 1 Studies of Novel Adenosine A2b Antagonist CVT-6883 Show Safety, Tolerability and Potential Utility i
November 02 2007 - 8:00AM
PR Newswire (US)
- CV Therapeutics exploring partnership opportunities to maximize
value for CVT-6883 - PALO ALTO, Calif., Nov. 2
/PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX)
announced today that data from a randomized, single-blind,
placebo-controlled, multiple ascending dose Phase 1 study of
CVT-6883, a potentially first in class adenosine A2B antagonist,
show that a range of doses were safe and well tolerated in 30
healthy volunteers. Preclinical data support the potential utility
of CVT-6883 in several disease areas where there is significant
unmet medical need, including chronic pulmonary diseases such as
asthma, chronic obstructive pulmonary disease and pulmonary
fibrosis. "The favorable safety and tolerability properties seen in
both of our Phase 1 studies, combined with the potential utility of
CVT-6883 for pulmonary and inflammatory diseases observed in
preclinical models, support further clinical development. We are
actively exploring partnership opportunities to maximize the value
of the CVT-6883 program as we continue to focus on our growing
Ranexa(R) business and building shareholder value," said Louis G.
Lange, chairman and chief executive officer of CV Therapeutics. CV
Therapeutics has developed CVT-6883 and has worldwide rights for
all potential indications. The compound is covered by an issued
United States patent that expires in 2022. In an earlier
randomized, double-blind, placebo-controlled, Phase 1 single
ascending dose study in 24 healthy volunteers, CVT-6883 was well
tolerated with no serious adverse events reported. Pharmacokinetic
results indicated the suitability of CVT-6883 for once daily
chronic dosing. The adenosine A2B receptor is expressed in the lung
and this expression can be increased significantly when lung
tissues become inflamed or injured. This is the scientific
rationale for why A2B receptor antagonists may be potentially
efficacious in treating chronic inflammatory diseases. Preclinical
data with CVT-6883 showed that CVT-6883 significantly reduced
elevated markers of inflammation, fibrosis and pulmonary injury in
several preclinical models. 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 inhibited pulmonary inflammation
and fibrosis induced by bleomycin. 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 product, Ranexa(R) (ranolazine
extended-release tablets), 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. CV
Therapeutics' clinical and preclinical drug development candidates
and programs include 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 cardiopulmonary diseases. 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 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 operating losses and fluctuations in
operating results; capital requirements; regulatory review and
approval of our products; special protocol assessment agreement;
the conduct and timing of clinical trials; commercialization of
products; market acceptance of products; product labeling;
concentrated customer base; reliance on strategic partnerships and
collaborations; uncertainties in drug development; uncertainties
regarding intellectual property; 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, 2007. CV
Therapeutics disclaims any intent or obligation to update these
forward-looking statements. DATASOURCE: CV Therapeutics, Inc.
CONTACT: John Bluth, Executive Director, Corporate Communications
& Investor Relations, CV Therapeutics, Inc., +1-650-384-8850
Web site: http://www.cvt.com/
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