We first featured Molecular Insight Pharmaceuticals, Inc. (Nasdaq: MIPI) on June 18th, after the company announced nonclinical data demonstrating the utility of the Company’s novel radiopharmaceutical compounds for the molecular imaging of prostate and other tumors at the Society of Nuclear Medicine (SNM) annual meeting in Salt Lake City.
Less than a week later, Molecular Insight Pharmaceuticals announced positive data from a completed Phase 2a clinical study of Azedra™, the Company’s lead oncology therapeutic for a common childhood cancer. Shares were up more than 65 percent from Wednesday’s closing price, in morning trading on Thursday on almost 10-times the company’s average three-month trading volume.
The company said data from the Azedra study showed that doses of 12 millicurie/kg to 18 millicurie/kg of the drug were tolerated without toxicity and the drug was active in tumors. The main goal of the study was to determine the maximum tolerated dose of Azedra.
“We showed that Ultratrace iobenguane I-131 with AHSC support is feasible at 18 mCi/kg without significant toxicity and with promising partial and complete responses that support proceeding to a pivotal Phase 2 study at18 mCi/kg,” said lead investigator Katherine K. Matthay, M.D., the Mildred V. Strouss Professor of Translational Cancer Research and Chief, Pediatric Hematology-Oncology in Department of Pediatrics at the University of California, San Francisco.
Azedra is currently in advanced clinical trials for the treatment of malignant pheochromocytoma, a rare, hard-to-access neuroendocrine tumor that develops in the core of an adrenal gland.