Biogen and CV Therapeutics Say Adenosine A1 Antagonist is Successful In A Phase II Trial CAMBRIDGE, Mass., and PALO ALTO, Calif., Feb. 17 /PRNewswire/ -- Biogen, Inc. (Nasdaq: BGEN) and CV Therapeutics, Inc. (Nasdaq: CVTX) today announced that Biogen's adenosine A1 antagonist/CVT-124 compound successfully completed a Phase II trial in patients with moderate-to-severe Congestive Heart Failure (CHF). Biogen said it would continue studies with its lead backup molecule.
Jim Vincent, Biogen's Chairman and Chief Executive Officer, said, "This Phase II trial validates the potential of this adenosine pathway in the cardio-renal syndrome that makes CHF such a deadly disease. We achieved statistical significance on key clinical endpoints and are very pleased with what we have learned about this pathway in our studies during the past three years. With this extensive experience, we believe we can make significant progress with this program as we move it through the clinic."
Adenosine A1 antagonist/CVT-124 is a highly selective small molecule adenosine A1 receptor antagonist that targets receptors in the kidney that are clinically relevant for the treatment of CHF. The Phase II trial was a randomized, double-blinded, placebo-controlled, dose-ranging study of the molecule in moderate-to-severe heart failure patients used in conjunction with standard therapies.
Biogen said it will make a milestone payment to CV Therapeutics, from which it licensed the program.
In addition to historical information, this press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Reference is made in particular to statements regarding continuation of clinical studies of a new adenosine A1 antagonist molecule and the expected progress of such studies. These statements are based on the Companies' current beliefs and expectations as to such future outcomes. Factors which could cause actual results to differ materially from the Companies' current expectations include the risk that the new molecule to be studied will not yield the same clinical results as the molecule that was the subject of the completed Phase II trial or that problems or delays may arise during preparations for future clinical trials or in the conduct of such trials or that problems may arise with respect to toxicology, formulation of manufacturing of the new molecule, as well as the other risks and uncertainties described from time to time in the Companies' periodic reports filed with the Securities and Exchange Commission. Drug development involves a high degree of risk. Success in early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful.
Biogen, Inc., winner of the 1998 U.S. National of Technology, is a biopharmaceutical company principally engaged in discovering and developing drugs for human healthcare through genetic engineering. Headquartered in Cambridge, MA, the Company's revenues are generated from worldwide sales of AVONEX(R) (Interferon beta-1a) for treatment of relapsing forms of multiple sclerosis, and from the worldwide sales by licensees of a number of products, including alpha interferon and hepatitis B vaccines and diagnostic products. Biogen's research and development activities are focused on novel products for multiple sclerosis, inflammatory, respiratory, kidney and cardiovascular diseases and in developmental biology and gene therapy. For copies of press releases and additional information about the Company, please consult Biogen's Homepage on the World Wide Web at biogen.com .
CV Therapeutics, Inc., headquartered in Palo Alto, CA, 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. CVT is currently conducting clinical studies for two of its products. Ranolazine, the first in a new class of drugs known as partial fatty acid oxidation (pFOX) inhibitors for the potential treatment of angina, is in Phase III clinical trials. CVT-510, for the potential treatment of atrial arrhythmias, is in Phase II clinical trials. For more information, please visit CV Therapeutics' web site at www.cvt.com.
Another biotech to look at. Jack |