Progenics Pharmaceuticals Inc. (PGNX: Quote) reported positive clinical data from a study of two novel radiolabeled small molecules targeting prostate-specific membrane antigen or PSMA. The imaging agents — 123I-MIP-1072 and 123I-MIP-1095 — had a high sensitivity of lesion detection in bone, tissue and the prostate gland with minimal retention in non-target tissue. The research was published as the cover article in the March issue of The Journal of Nuclear Medicine.
Separate phase 1 studies were conducted under an exploratory investigational new drug or IND application to measure the potential effectiveness of the small molecules in diagnosing and staging prostate cancer. In the first study, seven patients with documented prostate cancer were administered doses of 123I-MIP-1072 and 123I-MIP-1095, two weeks apart. In the second study, six healthy volunteers received 123I-MIP-1072 only. Whole body planar imaging and single photon emission computed tomography (SPECT)/computed tomography (CT) were performed for each group, and pharmacokinetics, tissue distribution, excretion, safety and organ radiation dose were analyzed.
Based on the data reported, Progenics is conductinga global, multi-center phase 2 trial investigating a next generation radiolabeled small molecule targeting PSMA, MIP-1404.
Prostate cancer is the most common form of cancer affecting men in the United States and is the second leading cause of cancer deaths among men each year. The American Cancer Society estimates that in 2013, 238,590 new cases of prostate cancer will be diagnosed and approximately 29,720 American men will die from the disease. Accurate diagnosis and staging of prostate cancer is critical to determining appropriate patient management.
by RTT Staff Writer
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