TrofexTM Demonstrates Potential to Rapidly Detect Prostate Cancer in Soft Tissues and Bone
CAMBRIDGE, - Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) today presented clinical data on a radiolabeled, small-molecule molecular imaging pharmaceutical in development for diagnosis and staging of prostate cancer at the 2009 annual meeting of the Society of Nuclear Medicine (SNM) in Toronto. Trofex™, which targets prostate specific membrane antigen (PSMA), a protein highly expressed by prostate tumor cells, has the potential to both detect and, when labeled with a therapeutic isotope, to treat metastatic prostate cancer. This was one of four conference presentations on products and technologies under development at Molecular Insight.
In 2008, Molecular Insight initiated clinical studies of Trofex in patients with documented prostate cancer and confirmed hormone refractory metastatic disease. Two internally developed Trofex compounds, MIP-1072 and MIP-1095, were evaluated for their capacity to visualize the disease and to define their pharmacokinetic profiles. Both agents rapidly detected metastatic prostate cancer lesions in soft tissues and bone, confirming that targeting the extracellular domain of PSMA is a viable approach for the molecular targeting of this cancer. The compounds were uniquely able to detect metastases within one to two hours after injection.
"Based on the potential demonstrated here, to rapidly and clearly image prostate cancer, we have planned additional studies to investigate the performance of these radiolabeled small molecules in patients with metastatic prostate cancer," said John W. Babich, Ph.D., Executive Vice President, Chief Scientific Officer and President of Research and Development at Molecular Insight Pharmaceuticals. "Not only does this data demonstrate the capability to rapidly visualize bone metastasis and soft tissue lesions -- that may be missed by conventional imaging techniques -- imaging can be done in a single day, which is not possible with some of the products currently on the market for imaging recurrent metastatic disease.
"Currently more than 2.5 million American men suffer from prostate cancer," Dr. Babich said. "About 200,000 new cases are diagnosed yearly and there are 30,000 deaths from the disease annually. Conventional imaging technologies lack both sensitivity and specificity for detecting metastatic disease. The targeting compound that we developed for imaging is an Iodine-123 labeled small-molecule candidate. But when the compound is labeled with Iodine-131 we believe we also may have the potential to treat metastatic prostate cancer. We are conducting preclinical studies to assess the potential of Trofex as a therapeutic. Trofex could dramatically change the diagnosis of prostate cancer, as well as the treatment landscape. Our plan for 2009 is to first complete a proof of concept and dosimetry trial for the detection of prostate cancer. Appropriate results in the additional pilot studies could support a request for fast-track development designation for the detection of metastatic disease."
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