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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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August 11, 2014
07:06 EDTPGNXSalix, Progenics receive FDA PDUFA date of September 29 for Relistor sNDA
Salix Pharmaceuticals (SLXP) and Progenics Pharmaceuticals (PGNX) announced that the FDA has informed Salix that the supplemental New Drug Application for RELISTOR Subcutaneous Injection, 20 mg/ml, for the treatment of opioid-induced constipation in patients taking opioids for chronic non-cancer pain has been assigned a user fee goal date of September 29.

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