Molecular Insight Pharmaceuticals Inc. has initiated a Phase 2 trial with Zemiva (iodofiltic acid I 123 or BMIPP) for the diagnosis of cardiac ischemia, or lack of sufficient blood supply to an area of the heart, in patients with suspected acute coronary syndrome (ACS) in the emergency department setting. Zemiva is a metabolic, molecular imaging pharmaceutical that has previously demonstrated the ability to detect cardiac ischemia up to 30 hours after an ischemic event as compared to currently available techniques, which are limited to an approximate two-hour imaging window. The current trial is designed to be a pivotal registration trial that, upon replication in a successive confirmatory Phase 3 trial, could form the basis of an application with the U.S. Food and Drug Administration (FDA) for marketing approval. Molecular Insight expects to report top line data from this trial in the second half of 2008.
The trial, which is expected to involve an estimated 600 to 700 patients at up to 70 centers in the United States and Canada, is an open-label study with patients serving as their own control. The secondary objective of the trial is to confirm the safety of a single injection of Zemiva in patients suspected of myocardial ischemia related to ACS as reported in previous trials.