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Progenics Reports Positive Preliminary Data From Ongoing Phase 1 Clinical Study Of PSMA ADC

A poster, entitled “Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase 1 trial in taxane-refractory prostate cancer” is being presented today by Daniel P. Petrylak, M.D., professor of Medicine, program director of the Genitourinary Oncology Section in the Division of Hematology/Oncology, and co-leader, Prostate Cancer in the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center. This poster will be available for the next 30 days on the Events page of Progenics’ website.

Phase 1 study design

The phase 1, open-label, dose-escalation clinical trial is being conducted in men with hormone-refractory prostate cancer that has progressed despite prior treatment with taxane-based chemotherapy regimens. In addition to assessing PSMA ADC’s safety and tolerability, the study includes evaluations of pharmacodynamics, changes in tumor burden, and changes in PSA and CTC values compared to baseline. PSA is a secreted protein that is unrelated to PSMA.

The initial 12-week clinical trial period evaluates up to four intravenous doses of PSMA ADC administered at three-week intervals. Following completion of the four doses, patients are offered, at their physicians’ discretion, the option to continue treatment with PSMA ADC for up to an additional 39 weeks. Qualified individuals receive up to 13 additional doses of study drug at three-week intervals.

About PSMA ADC

PSMA is a protein that is a validated biomarker of prostate cancer; it is expressed on the surface of prostate cancer cells as well as on blood vessels supplying other solid tumors. PSMA ADC combines a fully human monoclonal antibody selectively targeted to PSMA linked to a chemotherapeutic drug. Using technology licensed from Seattle Genetics, Inc. (Nasdaq: SGEN), the PSMA antibody is linked to monomethyl auristatin E, a compound that inhibits cell proliferation by disrupting the cellular “backbone” (i.e., microtubules) required for replication. The resultant antibody-drug conjugate attaches to the PSMA protein on the surface of prostate cancer cells and is designed to:

  • internalize into the cancer cell;
  • release active anti-cancer drug; and
  • destroy the malignant cell.

Unlike traditional chemotherapy, PSMA ADC is designed to deliver the drug selectively to prostate cancer cells by targeting PSMA. In pre-clinical studies, PSMA ADC exhibited a high level of tumor-specific activity.

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