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Molecular insight begins Trofex Ph. 1 trial for detection of metastatic prostate cancer

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 Director of Nuclear Medicine at Duke University Medical Center. "A targeted radiopharmaceutical capable of rapidly and accurately detecting the location of metastatic prostate cancer throughout the body, including the bone, would be a significant advance in patient care."

"In preclinical studies, both MIP-1072 and MIP-1095 have demonstrated promising attributes, such as high affinity for PSMA, significant uptake into tumor cells and favorable clearance from normal tissues," said John W. Babich, Ph.D., President and CSO of Molecular Insight. "The exploratory IND process accelerated our entry into the clinic to evaluate which compound is the more promising for further development. We plan to complete this study in the second half of 2008 and then, once initial safety and imaging efficacy criteria are met, advance the selected lead candidate into expanded Phase 2 clinical development." Dr. Babich noted that preclinical data in support of MIP-1072 and MIP-1095 were presented in October 2007 at the AACR-NCI-EORTC meeting on "Molecular Targets and Cancer Therapeutics."

The trial, which will involve up to 12 patients, is a single-blind, randomized cross-over study. Patients will receive a single dose of MIP-1072 or MIP-1095, followed by a single dose of the alternate candidate compound 14 days later. The study is being conducted at Duke University Medical Center, New York Presbyterian Hospital-Cornell Medical Center and Johns Hopkins Hospital.

The primary objective of the trial is to evaluate the pharmacokinetics and organ radiation dosimetry of the two compounds in patients diagnosed with prostate cancer who have evidence of recurrent metastatic disease. Secondary objectives include assessments of excretion, metabolism, safety and optimization of tumor imaging parameters.


Contact: Priscilla Harlan
Edelman Public Relations

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