Molecular Insight Pharmaceuticals
Based: Cambridge, MA
Founded: 1997
www.molecularinsight.com

Bottom line: Making tough choices, but getting help from the NIH 

What we said: When Molecular Insights counted up the cash from its third venture round, it was 50 percent oversubscribed. The $28 million deal positions the biotech to push its lead product, BMIPP, into Phase III. BMIPP is a molecular imaging pharmaceutical that enables the detection of cardiac ischemia based on changes in cardiac cell metabolism. The efficacy of current imaging agents used in acute care settings is restricted to two hours after the chest pains stop. BMIPP promises to open that window to 30 hours, offering a big advance for a quite common medical need. If the biotech can prove the imaging mechanism works as advertised, it will allow for a big improvement in the way in which patients complaining of chest pains can be diagnosed in an acute care facility.

What happened: The financial famine that hit a year ago forced Molecular Insight (MIPI) to make a few Darwinian choices. With new financing deals hard to come by, the developer had to concentrate its resources on two lead programs. But then, as process development chief James Kronauge told Mass High Tech, the NIH came through with $1.2 million in Small Business Innovation Research grants that enabled the developer to get one of its projects off the shelf. The potential diagnostic for neuroblastoma is now the lead program. More money has followed, and the company says it is in full swing.

Molecule Insight is involved in developing therapeutic radiopharmaceuticals and targeted molecular imaging agents for use in oncology and cardiology. The company recently released promising one-year follow-up data from a Phase I dose-escalation clinical study of Azedra, with a durable tumor response in neuroendocrine cancer patients. And it began a mid-stage trial for Azedra, which won the FDA's orphan drug status, last August. Molecular Insights has four oncology programs underway, including a focus on the tumor drug Onalta. In March the developer released positive results for the Phase II trial of Zemiva, a molecular imaging radiopharmaceutical the company is developing to detect early signs of cardiac ischemia, the lack of sufficient blood flow to the heart, which can lead to heart attacks. The company's web site notes that discussions with the FDA on a Phase III are ongoing.