Endocyte narrows Phase I development program for CRPC candidate EC1169

Endocyte Inc. (NASDAQ:ECYT) will narrow its development program for EC1169 to focus on the cohort of up to 50 taxane-exposed, metastatic castration-resistant prostate cancer (CRPC) patients in a Phase Ib trial. The company will stop enrollment of taxane-naïve patients. Endocyte expects to report top-line efficacy data from the expansion portion this year, and complete Phase I enrollment in 3Q17.

The open-label, U.S. trial is evaluating up to 6.5 mg/m² EC1169. The primary endpoints are maximum tolerated dose (MTD) in the part A portion and radiographic progression-free survival (PFS) in prostate-specific membrane antigen (PSMA; FOLH1; GCPII)-positive patients in the part B portion. Secondary endpoints include safety in the part A portion and time to Prostate Cancer nClinical Trials Working Group 3 (PCWG3)-defined lack of clinical benefit and median PFS in the part B portion...