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Biotech / Medical : CVTX - CV Therapeutics, Inc.

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From: Doc Bones	4/18/2005 9:14:12 AM
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CV Therapeutics Meets Ranexa Endpoint Monday April 18, 8:35 am ET CV Therapeutics' Ranexa Shown to Reduce Frequency of Angina Attacks in Study PALO ALTO, Calif. (AP) -- CV Therapeutics Inc. said Monday that its Ranexa treatment was shown to reduce the frequency of angina attacks in patients compared with a placebo in a clinical trial. CV shares rose $3.57, or 17.2 percent, to $24.30 in premarket activity. The drug maker received an approvable letter for the drug in October 2003 from the Food and Drug Administration and conducted the study to satisfy requirements of that letter. CV plans to submit an amendment to its new drug application by the third quarter, which could mean a possible U.S. launch of the product by the second half of 2006. The company is looking for an approval to treat angina in a restricted patient population. Angina, or chest pain that occurs when oxygen rich blood is prevented from reaching the heart because of blockage, affects about 6.4 million people in the United States. Ranexa is a novel small molecule that interferes with the heart's access to fatty acids and increases its consumption of sugar, allowing it to need less oxygen. CV said that Ranexa was well-tolerated in the 565-patient trial and did not result in fainting or dizziness. The company plans to present the results at an unnamed scientific conference later. biz.yahoo.com

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