Cambridge, MA-based Molecular Insight Pharmaceuticals said today that its experimental imaging agent, when combined with standard diagnostic tests, reached its goal in a clinical trial of detecting early signs of cardiac ischemia—or reduced blood flow to the heart–which can lead to a heart attack or stroke.
Molecular Insight (NASDAQ: MIPI) said the Phase II study enrolled 510 patients who were brought to the hospital with chest pain and were suspected to be at risk of a heart attack or stroke. The patients got either a combination of a scan using the company’s imaging agent (called Zemiva) and standard diagnostic tests, or the typical workup alone. Researchers found the study reached its main goal of accurately improving the detection of ischemia over the standard of care. The results from this study, called BP-23, confirmed the findings from an earlier mid-stage study called BP-21.
Molecular Insight’s imaging product is a fatty acid attached to a radioactive molecule. Healthy heart muscle cells absorb the fatty acids and begin to metabolize them, while the unhealthy cells can’t do so—because of this, when a patient’s heart is viewed with a nuclear medicine camera, Molecular’s imaging agent shows up in the healthy tissue but not in diseased regions of the heart, helping clinicians detect damage, Molecular’s acting CEO John Babich explained to Ryan earlier this week in an interview.
The company believes this test will offer a convenience advantage over conventional testing. The standard tools enable pictures of blood flow to help doctors diagnose heart conditions, but they rely on stress tests (such as walking on a treadmill) to get the heart moving and take several hours to provide a diagnosis, Babich says. One key difference with Molecular’s product, he said, is that it can enable imaging without stress tests, and diagnostic imaging can be done 10 minutes after injection, Babich says. The imaging agent could be used to quickly diagnose some 3.5 million Americans per year who enter emergency rooms with symptoms of heart disease, he says.
Based on the positive finding in a Phase II study, Molecular Insight plans to discuss the design of a late-stage clinical trial in the first three months of 2009, Babich says. The company’s imaging agent has already been cleared for three years in Japan, and marketed under the name Cardiodine.
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