Progenics Pharmaceuticals, Inc., a biopharmaceutical company, has recently announced that its first patient has been dosed for treatment of Metastatic Prostate cancer, in a phase 2 clinical study of 1095 radiotherapy. The clinical study evaluated I-131 1095 radiotherapy in combination with enzalutamide to treat mCRPC (metastatic castration resistant prostate cancer), reports source.

As per credible sources, a placebo controlled phase 2 clinical study is evaluating the efficiency of 1095 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer, who are new to chemotherapy, PSMA-avid & progressed on abiraterone. 18F-DCFPyL, the company’s patented imaging agent to visualize cancer, will be used to determine PSMA-avidity.

Nuclear Medicine Physician at LHSC, Scientist at Lawson Health Research Institute & Joseph’s Health Care London, Canada, Dr. David Laidley, was reported to say that 1095 radiotherapy is a potential treatment option for prostate cancer as it may overcome resistance developed to new androgen axis drugs, such as enzalutamide and abiraterone. Th resistance of anti-androgen drugs in the pre-chemotherapy patients is growing, which further reinforces need to advance new targeted therapies.

Asha Das, M.D., Chief Medical Officer, Progenics Pharmaceuticals, Inc., was reportedly quoted saying that phase 2 clinical study of 1095 radiotherapy to treat metastatic patients at an earlier stage utilizing a differentiated, PSMA-targeted approach, is a significant milestone.

Data from the study demonstrated 1095’s potential to reduce PSA & bone pain in heavily pretreated prostate cancer patients and was well tolerated. The preclinical data suggest combination of radiotherapy & enzalutamide is potentially a more effective treatment model for patients with mCRPC., Das added.

As per sources close to the matter, the study is expected to enroll 120 patients at 25 sites in Canada and the U.S. The study’s main endpoint is PSA (prostate specific antigen) response rate, according to PCWG3 (Cancer Clinical Trials Working Group 3). The criteria include a confirmed 50 per cent or greater decline from baseline. The secondary endpoint to evaluate response is based on RECIST (Response Evaluation Criteria in Solid Tumors), for soft tissue, PFS (progression free survival) and overall survival. Patients will be followed for 1 year after their first treatment of all efficacy endpoints.

Source credits: https://progenicsgc.gcs-web.com/news-releases/news-release-details/progenics-pharmaceuticals-doses-first-patient-phase-2-clinical