FDA indicated a quick approval for MIPI 's Zemiva
FDA indicated a quick approval for MIPI 's ZemivaMolecular Insight Pharma (NASDAQ:MIPI)
: In March 2009, MIPI provided positive detailed data on Phase 2 clinical trial for Zemiva. In the trial, the combination of Zemiva imaging with initial clinical diagnostic information resulted in improved sensitivity for detecting ischemia (85%) that was statistically significant (p < 0.0001), when compared to the sensitivity of the initial clinical diagnosis alone (52%). Zemiva enables rapid detection of acute cardiac ischemia in the emergency room setting. The FDA has indicated that a single Phase 3 trial, with robust results, would be sufficient to support Zemiva's approval. The Company's goal is to obtain FDA agreement on a Phase 3 study protocol by the end of 2009 and to begin the trial in early 2010. MIPI has a Special Protocol Assessment (SPA) letter in place from the FDA which approves the design of a pivotal Phase 2 trial for registration of the Company's lead oncology candidate, Azedra (Ultratrace Iobenguane I 131, formerly known as Ultratrace MIBG). The pivotal Phase 2 study (IB-I2b) will be a single-arm trial conducted in 58 adults with pheochromocytoma. MIPI plans to complete a Phase 3 clinical trial development program for Europe and initiate a study in the U.S. for Onalta that would validate an imaging surrogate for the candidate. Onalta is the Company's radio-therapeutic product candidate under development for the treatment of metastatic carcinoid and pancreatic neuroendocrine tumors in patients whose symptoms are not controlled by conventional therapy.