CVTX CV Therapeutics (MM)

Approval-Enabling Study of Ranexa(TM) Enrolling Ahead of Schedule PALO ALTO, Calif., Oct. 26 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (NASDAQ:CVTX) announced today that investigators have, to date, been enrolling angina patients into the potentially approval-enabling study of Ranexa (ERICA -- Evaluation of Ranolazine In Chronic Angina) ahead of schedule. Should the current rate of enrollment continue, the company now expects that patient enrollment should be completed by the end of the first quarter of 2005 and data could then be available late in the second quarter or early in the third quarter of 2005. Since it began in August 2004, the study has enrolled 372 of the approximately 500 patients expected to be enrolled. "We are very pleased with the rapid rate of enrollment we have seen in this study to date. Should this rate of enrollment continue, we would expect to complete enrollment sooner than we had originally anticipated," said Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics. Prior to the initiation of the study, the company had expected to complete enrollment by the end of 2005. As previously announced, CV Therapeutics and the U.S. Food and Drug Administration (FDA) have reached written agreement on a protocol for this clinical trial which, if successful, could support the approval of Ranexa for the treatment of chronic angina in a restricted patient population. This agreement was reached under the FDA's special protocol assessment (SPA) process. If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 25 years. Chronic angina is a serious and debilitating heart condition, usually associated with coronary artery disease and marked by repeated and sometimes unpredictable attacks of chest pain. It affects approximately 6.8 million people in the United States. Study Details The study, known as ERICA (Evaluation of Ranolazine In Chronic Angina), is a multi-national, double-blind, randomized, placebo-controlled, parallel group study to evaluate the effectiveness of Ranexa (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients are being randomized to receive Ranexa 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine, during a six week assessment period. The primary efficacy endpoint of ERICA is angina frequency. Based on the reduction in angina frequency observed in the Phase III CARISA study, ERICA is calculated to be 95 percent powered to detect a statistically significant reduction in angina frequency due to Ranexa. In CARISA, Ranexa (1000 mg) reduced the frequency of angina by an average of 1.2 attacks per week, compared to placebo (p