Progenics Pharmaceuticals, Inc. (PGNX) Opens Enrollment in Phase 2 Clinical Trial of PSMA ADC in Prostate Cancer Patients

Progenics Pharmaceuticals has opened enrollment in a phase 2 study of its PSMA ADC compound for prostate cancer patients. PSMA ADC is a targeted anti-cancer therapeutic that uses a monoclonal antibody for cell killing drug delivery to malignant cells.

“New prostate cancer therapies are in high demand. Patients with advanced, hormone-refractory prostate cancer typically do not survive more than 12 to 18 months,” said Daniel 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. “The hope for PSMA ADC is that its targeted therapeutic approach could be more effective and cause fewer toxic side-effects in treating cancer.” Dr. Petrylak participated as an Investigator in the phase 1 trial of PSMA ADC and is continuing his evaluation of PSMA ADC in this phase 2 study.

The phase 2 trial is a multicenter, open-label study designed to assess the anti-tumor activity and tolerability of PSMA ADC in up to 75 subjects who have maetastatic castration-resistant prostate cancer. The test will consist of each patient receiving eight doses of PSMA ADC at 2.5 mg/kg. At the conclusion of the study, responses in prostate specific antigen (PSA); circulating tumor cells (CTC); pain; and bone, visceral, and nodal metastases will be evaluated. Safety of the compound will be assessed as well.

“This is an exciting moment — for Progenics and for the patients we seek to serve — as we move PSMA ADC into its next phase of clinical testing,” said Robert J. Israel, M.D., Progenics’ Senior Vice President, Medical Affairs & Clinical Research. “This type of cancer therapy is unique and we believe that PSMA ADC is the most advanced clinical-stage candidate antibody-drug conjugate in development to treat prostate cancer.”

PSMA ADC is an innovative compound designed to deliver a cell-killing drug exclusively to prostate cancer cells through the targeting of prostate specific membrane antigen (PSMA). PSMA is a validated biomarker of prostate cancer that is expressed on the surface the cells, in addition to the blood vessels supplying other solid tumors. PSMA ADC consists of a fully human monoclonal antibody, the binding agent for PSMA, linked to a cytotoxic drug called monomethyl auristatin E (MMAE). MMAE fights the cancer cells by inhibiting cell proliferation through the cellular “backbone” required for replication. This antibody-drug combination kills the malignant cells by being absorbed by the cell and releasing active anti-cancer drug.

Phase 1 clinical trial data will be presented at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics to be held November 6-9 in Dublin, Ireland. Progenics previously presented positive preliminary phase 1 data at the annual meeting of the American Society of Clinical Oncology (ASCO). Robust antitumor activity was observed across a range of doses, and durable responses were seen in heavily pre-treated patients. Doses up to and including 2.5 mg/kg were generally well tolerated. Dose limiting toxicities, primarily neutropenia, were seen at 2.8 mg/kg.

For further information, please visit www.progenics.com and www.relistor.com

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