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Biotech / Medical : CVTX - CV Therapeutics, Inc. -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (38)	11/14/2001 2:41:19 PM
From: tnsaf	Respond to of 411

Market goes wild on this news. Jason ANAHEIM, Calif., Nov 14 (Reuters) - CV Therapeutics Inc. (NasdaqNM:CVTX - news) said on Wednesday that a pivotal trial of its experimental drug ranolazine met its main goal of allowing patients with cardiac pain to exercise for longer periods, and also showed a lower incidence of pain attacks. ADVERTISEMENT Its shares soared $11.61, or about 31 percent, to $50 in Wednesday afternoon trade on Nasdaq. When used in combination with other drugs for chest pain, ranolazine increased treadmill exercise time by a statistically significant 24 seconds compared to a placebo, according to Dr. Bernard Chaitman, the trial's lead investigator. Chaitman, the director of cardiovascular research at St. Louis University School of Medicine, said Wednesday at a meeting of the American Heart Association here that the 12-week, 823-patient trial showed that the drug cut by 25 percent the incidence of chest pain attacks, or angina, in patients with chronic symptoms. About 6.4 million people in the United States suffer from angina, which is caused by reduced oxygen to the heart and can eventually lead to heart attacks. ``A 25 percent reduction in symptoms represents a huge leap in quality of life,'' CV Therapeutics' Chief Executive Louis Lange told Reuters. ``People with chronic angina downsize their lives for fear of heart attacks.'' The drug had only minimal effects on heart rate and blood pressure, Chaitman said. ``Currently available drugs affect heart rate, blood pressure and pumping function, making them hard to use in patients with other conditions, such as heart failure or lung disease,'' the investigator said. Ranolazine, the first in a new class of compounds known as partial fatty acid inhibitors, works by directing the heart muscle to burn glucose rather than fat, allowing angina patients to engage in physical activity for longer periods. ``Overall the data looks very clean and very positive,'' Eric Hecht, an analyst at Merrill Lynch, said. He noted that the side-effect profile of the CV Therapeutics drug also looked good. ``There is no drug with no side effects. So there was some more dizziness and such in the clinical trial. The side effects were balanced across the placebo and treatment arm,'' the analyst said. Chaitman said the trial did reveal a slight increase in the risk of arrhythmia from ranolazine, but he said the risk was similar to that of other antianginal treatments. ``The side effects were 6 to 8 percent over placebo, but that compares to 34 to 40 percent with current drugs,'' Lange said. The CEO also said the 24-second average increase in exercise time is similar to patient benefits seen in an earlier Phase 3 trial of ranolazine as a stand-alone therapy. The company plans to file sometime in the second half of next year for U.S. Food and Drug Administration approval of the drug, after analyzing the latest trial data to reflect effectiveness in various subgroups, such as heart failure patients, Lange said. The primary goal of the trial was to determine the amount of time patients taking ranolazine could exercise without being limited by symptoms of angina. Lange said the trial also met 16 out of 18 secondary goals, including episodes of angina.