Progenics Pharmaceuticals (NASDAQ:PGNX) dosed the first patient in a Phase 2 clinical study evaluating I-131 1095 radiotherapy for the treatment of metastatic castration resistant prostate cancer (mCRPC).
1095 is a small molecule radiotherapeutic designed to selectively bind to the extracellular domain of prostate specific membrane antigen (PSMA).
The trial will evaluate the safety and efficacy of 1095 in combination with enzalutamide, compared with enzalutamide alone, with a primary endpoint of prostate specific antigen (PSA) response rate, defined as a reduction of 50% or greater from baseline.
“The commencement of patient dosing in our Phase 2 clinical study is a significant step forward for the development of 1095, which has the potential to treat metastatic patients at an earlier stage utilizing a differentiated, PSMA-targeted approach,” Dr. Asha Das, Progenics’ CMO, said in a statement.
“Data from a compassionate use study has already demonstrated 1095’s potential with marked reduction of PSA and bone pain in a group of heavily pretreated advanced prostate cancer patients and was well tolerated,” she added.
Progenics expects to enroll some 120 patients in the study and, if successful, the company plans to initiate a pivotal trial in 2020.