Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) announced today that it has initiated a Phase 1 clinical trial for its Trofex molecular imaging program for the detection and staging of metastatic prostate cancer. The trial is designed to investigate two small molecule radiopharmaceutical candidates that target prostate-specific membrane antigen (PSMA), MIP-1072 and MIP-1095, in order to select a lead candidate for further development and commercialization. Molecular Insight is conducting the study under an exploratory Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration (FDA).
"Trofex expands our oncology portfolio into the arena of molecular imaging radiopharmaceuticals for the detection, monitoring and staging of disease such as prostate cancer, providing an important strategic complement to our portfolio of molecular radiotherapeutics for cancer," said David S. Barlow, Chairman and CEO of Molecular Insight. "Trofex is now our fourth clinical-stage program, joining Zemiva, Azedra and Onalta. Both candidate compounds in this Trofex clinical study were discovered in-house by applying our expertise in molecular targeting, drug design and radiochemistry towards the detection and monitoring of prostate cancer."
MIP-1072 and MIP-1095 are radiolabeled small molecules developed by Molecular Insight that target PSMA, a protein that is highly expressed by prostate cancer cells. PSMA is well established as a molecular target for prostate cancer and coupling it with an imaging radionuclide enables a rapid, non-invasive way to detect the location of metastatic cancer.
"Prostate cancer is the second leading cause of cancer death in men in the United States, and new methods to detect, stage and monitor disease progression are urgently needed for more effective patient management of this disease," said Dr. R. Edward Coleman, M.D., Vice-Chair, Department of Radiology, Professor of Radiology and Directo
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Edelman Public Relations