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Biotech / Medical : CVTX - CV Therapeutics, Inc.

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From: mopgcw7/14/2005 8:00:23 AM
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CV Therapeutics Initiates Clinical Program for Potential Novel Treatment of Asthma
Wednesday July 13, 4:15 pm ET

PALO ALTO, Calif., July 13 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) today announced that it has initiated a clinical program for CVT-6883, a selective, potent and orally available A2B-adenosine receptor antagonist, intended to treat asthma with once a day dosing.
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Blockade of the A2B-adenosine receptor may limit or prevent mast cell degranulation, which in turn may lead to bronchoconstriction and the inflammatory process associated with asthma and cardiopulmonary disease. Therefore, CVT-6883 could potentially offer a new therapeutic approach to asthma.

"Existing therapies for asthma typically target various downstream aspects of the immune response, but, if it is shown to be safe and effective, CVT-6883 could potentially treat the problem upstream by blocking the A2B-adenosine receptor and inhibiting the inflammatory process of respiratory disease," said world-renowned asthma researcher, Stephen Holgate, M.D., MRC Clinical Professor of Immunopharmacology at the University of Southampton School of Medicine in the United Kingdom.

"CVT-6883 represents novel science and targets a significant patient population with substantial unmet needs. We are very excited to advance this innovative anti-inflammatory compound from our research pipeline into clinical development," said Louis Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics.

A randomized, double-blind, placebo-controlled, single dose Phase I study of oral CVT-6883 in 24 healthy adults is assessing the safety and tolerability of a range of doses of CVT-6883.

CV Therapeutics has a United States patent covering CVT-6883 and other proprietary selective adenosine A2B-receptor antagonists.

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.

About CVT-6883

CVT-6883 is a selective A2B-adenosine receptor antagonist for the potential treatment of asthma. In asthma, naturally 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. By selectively inhibiting the A2B-adenosine receptor, CVT-6883 is intended to potentially prevent or reduce this inflammatory process.

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 multiple clinical development drug candidates and has entered into an agreement with Solvay Pharmaceuticals, Inc. to co-promote ACEON® (perindopril erbumine) Tablets in the United States.

CV Therapeutics has received an approvable letter from the U.S. Food and Drug Administration (FDA) relating to its new drug application for Ranexa(TM) (ranolazine) for the potential treatment of chronic angina, and has submitted an application for the approval of ranolazine for the potential treatment of chronic angina to the European Medicines Agency. Regadenoson is a selective A2A-adenosine receptor agonist for potential use as a pharmacologic stress agent in myocardial perfusion imaging studies. Tecadenoson is a selective A1-adenosine receptor agonist for the potential reduction of rapid heart rate during atrial arrhythmias. Adentri(TM) is a selective A1-adenosine receptor antagonist for the potential treatment of heart failure and has been licensed to Biogen Inc. (now Biogen Idec Inc.). CVT-6883 is a selective A2B-adenosine receptor antagonist for the potential treatment of asthma.

Ranexa, regadenoson, tecadenoson, Adentri and CVT-6883 have not been approved for marketing by the FDA or any foreign regulatory authorities. These products are subject to United States Investigational New Drug applications, and as applicable, appropriate clinical trial applications to regulatory authorities outside the United States.
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