CV Therapeutics Inc has initiated enrolment in the MERLIN (Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes) TIMI-36 study of Ranexa. MERLIN TIMI-36 is being conducted under the US FDA special protocol assessment (SPA) process, and if successful, could support approval of Ranexa as first-line therapy for patients suffering from chronic angina. This study could also result in approval for treatment of acute coronary syndromes (ACS) and for long-term prevention of ACS.
"We are very pleased to begin enrolment in this important study, which could bring us closer to our goal of commercializing Ranexa for a broad population of patients with ischemic conditions such as angina," said Louis G Lange, chairman and chief executive officer of CV Therapeutics, Inc.
MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Ranexa during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes treated with standard therapy. The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with Ranexa compared to placebo. The oral doses of Ranexa used in MERLIN-TIMI 36 have been studied in previous Phase 3 clinical trials.
Approximately 600 study sites worldwide are expected to enrol patients. Based on historical clinical trial information from the TIMI Study Group, preliminary data could be available by the end of 2006.
The SPA process creates a binding written agreement between the sponsoring company and the FDA concerning clinical trial design, clinical endpoints, study conduct, data analysis and other clinical trial issues. It is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a new drug application (NDA).
The MERLIN TIMI-36 study is being conducted by the Harvard-based Thrombolysis In Myocardial Infarction (TIMI) Study Group, under the direction of Eugene Braunwald, and David Morrow.
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.
CV Therapeutics Inc 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.