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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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January 23, 2015
08:09 EDTPGNXProgenics relaunches Azedra Phase 2 clinical study
Progenics Pharmaceuticals announced that it has dosed the first subject in the resumed pivotal Phase 2 clinical study of Azedra in patients with malignant pheochromocytoma and paraganglioma. The trial is being conducted under a Special Protocol Assessment, or SPA, with the FDA. Progenics acquired Azedra in conjunction with its 2013 acquisition of Molecular Insight Pharmaceuticals, or MIP. The study is designed to evaluate the efficacy and safety of the administration of two therapeutic doses of Azedra in patients with malignant relapsed/refractory pheochromocytoma or paraganglioma, ultra-orphan cancers with limited treatment options. The primary objective of the study is to determine the clinical benefit of Azedra based on the proportion of study participants with a reduction of all antihypertensive medication by at least 50% for at least six months. The SPA requires that 25% of 58 evaluable patients achieve the primary endpoint. In late 2010, MIP suspended enrollment in the trial to seek additional funding. The trial has now resumed to fulfill enrollment requirements under the SPA.
January 20, 2015
10:06 EDTPGNXHigh option volume stocks
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January 14, 2015
09:48 EDTPGNXProgenics management to meet with Brean Capital
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