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- Outcomes From Clinical Study in Prostate Cancer Presented at Genitourinary Cancers Symposium -
TARRYTOWN, N.Y., Feb. 14, 2013 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today reported positive clinical data from a completed phase 1 study of PSMA ADC, an antibody-drug conjugate (ADC) designed to selectively deliver chemotherapy to cells that express prostate-specific membrane antigen (PSMA). 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 (ASCO), the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO).
Fifty-two patients with metastatic castration-resistant prostate cancer (mCRPC) 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.
A poster entitled "Prostate-Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC): A Phase 1 Trial in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated with Taxane" is being presented today by Daniel P. Petrylak, M.D., Director of the Prostate Cancer Program/Genitourinary Cancer Program and Co-Director of the Signal Transduction Program at Yale University Medical Center. This poster will be available for the next 30 days on the Events page at
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 (PSA); circulating tumor cells (CTC); pain; and change in tumor size as measured under RECIST criteria. Safety also is being evaluated.