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February 14, 2013
11:51 EDTPGNXProgenics presents data from Phase 1 study of PSMA ADC
Progenics Pharmaceuticals reported positive clinical data from a completed phase 1 study of PSMA ADC, an antibody-drug conjugate designed to selectively deliver chemotherapy to cells that express prostate-specific membrane antigen. PSMA ADC was generally well tolerated in patients at doses up to and including 2.5 mg/kg, the maximum tolerated dose. Findings were presented at the 2013 Genitourinary Cancers Symposium, a meeting co-sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology and the Society of Urologic Oncology. Fifty-two patients with metastatic castration-resistant prostate cancer were dosed at nine dose levels. Significant antitumor activity was observed across doses ranging from 1.8 mg/kg to 2.8 mg/kg. Dose limiting toxicities, primarily neutropenia, were seen at 2.8 mg/kg. The most commonly reported adverse events were anorexia and fatigue. Progenics opened enrollment in a subsequent phase 2 study of PSMA ADC in September 2012. This ongoing trial is an open-label, multicenter study assessing the anti-tumor activity and tolerability of PSMA ADC in up to 75 subjects with mCRPC. Patients are receiving a total of eight doses of drug at 2.5 mg/kg. The study endpoints evaluate responses in prostate specific antigen; circulating tumor cells; pain; and change in tumor size as measured under RECIST criteria. Safety also is being evaluated.
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October 20, 2014
08:19 EDTPGNXProgenics presents data from Phase 2 trial of 1404 PSMA imaging agent
Progenics Pharmaceuticals announced that data from a Phase 2 trial of its PSMA imaging agent candidate, 1404, have been presented at the 27th Annual European Association of Nuclear Medicine Congress being held in Gothenburg, Sweden. 1404 is a targeted small molecule designed to "visualize" prostate cancer by targeting prostate specific membrane antigen. "The Phase 2 data are quite impressive and demonstrate how SPECT/CT with 1404 may provide a more accurate assessment of the presence, location and extent of prostate cancer," said Dr. Dabasi. Gabriella Dabasi, Ph.D. presented, "1404 may provide prognostic information for both primary and metastatic disease in a single procedure, which could greatly enhance the clinical decision-making process. There is a strong rationale for continued development of this promising molecular imaging agent." In the Phase 2 trial, SPECT/CT imaging with 1404 showed 94% sensitivity in detecting and imaging cancer in the prostate gland of high-risk patients prior to prostatectomy. In addition, 1404 was more sensitive than MRI in detecting primary prostate cancer and was a good predictor of lymph node involvement at prostatectomy. SPECT/CT imaging with 1404 identified 14 more patients with suspicious lymph node sites than MRI. Uptake of 1404 in the lobes of the prostate gland showed a highly significant correlation with Gleason score. The data also showed uptake of 1404 in the primary tumor was significantly lower in treated patient, corresponding to a decrease in PSA over time observed in these treated patients.

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