- 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 www.progenics.com. 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.