Tuesday, December 23, 2008

Molecular Insight cardiac ischemia drug shows improvement

By Marc Songini

Cambridge-based Molecular Insight Pharmaceuticals Inc. claims one its lead drugs, Zemiva, can improve cardiac ischemia detection by about one half, according to the results of a Phase 2 clinical study.

Molecular Insight (NASDAQ: MIPI) made the announcement on Tuesday. Zemiva is a fatty acid analog that detects cardiac ischemia, or blockage of a coronary artery, by showing abnormalities in the fatty acid metabolism of the heart. Zemiva is visible via any standard nuclear medicine camera, which is found in all accredited U.S.-based hospitals. It’s believed Zemiva can help quickly and accurately diagnose those chest pain patients actually suffering from cardiac ischemia and allow them to be admitted immediately for treatment.

The Phase 2 clinical trial indicated that applying Zemiva with standard diagnostic tools improved detection of cardiac ischemia by more than 50 percent. This occurred in patients whose symptoms had faded as many as 30 hours before the Zemiva scan, Molecular Insight claimed in a statement. Moreover, in the 30-day follow-up, those patients with a negative Zemiva scan reading suffered no subsequent cardiac events, including myocardial infarctions (heart attacks).

Additionally, the patients tolerated Zemiva well, with no serious side effects. The trial involved 510 patients over 14 months at 50 hospitals. Given these results, Molecular Insight intends to proceed with Zemiva development. This includes opening a dialogue with the U.S. Food and Drug Administration (FDA) prior to a Phase 3 trial design.
 
Current diagnostic procedures, including examination and blood testing, can confirm cardiac ischemia in 1 million of the 6 million patients who visit the hospital annually. However, a remaining 3.5 million patients with cardiac ischemia symptoms whose exact status is unknown require hospital admission, costing more than $6 billion in additional expenses.

Last month, for third-quarter 2008, Molecular Insight reported a net loss of $24.7 million, up from a net loss of $13.2 million in the same quarter of 2007.