Progenics Pharmaceuticals Doses First Patient in Phase 2 Clinical Study of 1095 Radiotherapy

Progenics Pharmaceuticals (NASDAQ:PGNX) has announced the first patient in its Phase 2 clinical trial studying I-131 1095 radiotherapy has been dosed to treat metastatic castration resistant prostate cancer (mCRPC).

As quoted in the press release:

1095 is the Company’s small molecule radiotherapeutic designed to selectively bind to the extracellular domain of prostate specific membrane antigen (PSMA).

“1095 radiotherapy represents a targeted treatment option for prostate cancer with a new mechanism of action that may overcome resistance developed to novel androgen axis drugs, such as abiraterone and enzalutamide,” said Dr. David Laidley, Nuclear Medicine Physician at London Health Sciences Centre (LHSC) and Scientist at Lawson Health Research Institute, the research institute of LHSC and St. Joseph’s Health Care London in Ontario, Canada. “The growing resistance to these anti-androgen drugs in the pre-chemotherapy patient population further reinforces the unmet need for novel targeted therapies.”

The multicenter, randomized, open-label, controlled Phase 2 clinical study is evaluating the efficacy and safety of 1095 in combination with enzalutamide compared to enzalutamide alone in patients with mCRPC who are PSMA-avid, chemotherapy naïve, and progressed on abiraterone. PSMA-avidity is determined utilizing PyL™ (¹⁸F-DCFPyL), the Company’s PET imaging agent in clinical development designed to visualize prostate cancer. The trial is expected to enroll approximately 120 patients at 25 sites in the U.S. and Canada. The study’s primary endpoint is prostate specific antigen (PSA) response rate according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria defined as a confirmed 50% or greater decline from baseline. Key secondary endpoints evaluate radiographic response based on Response Evaluation Criteria In Solid Tumors (RECIST) for soft tissue or PCWG3 for bone, progression free survival (PFS), and overall survival (OS). Patients will be followed for one year after their first treatment for all efficacy endpoints. Survival and safety data will be collected for an additional year.

Click here to read the full press release.