BioCentury
ARTICLE | Clinical News

Progenics' prostate cancer imaging agent meets specificity endpoint in Phase III

September 21, 2018 4:41 PM UTC

Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) said SPECT/CT imaging with its 99mTc-MIP-1404 (1404, F-1311) imaging agent met the co-primary endpoint of specificity but missed the co-primary endpoint of sensitivity in a Phase III trial to detect low-grade prostate cancer. The company plans to complete an analysis of the data next quarter in order to determine a path forward for 99mTc-MIP-1404, a technetium-99m-labeled small molecule targeting the extracellular domain of prostate-specific membrane antigen (PSMA; FOLH1; GCPII).

The open-label, U.S. and Canadian trial dosed 471 men who had a diagnostic transrectal ultrasound guided biopsy with a histopathologic finding of Gleason score ≤3+4 who were candidates for active surveillance and were undergoing routine biopsy or voluntary radical prostatectomy with or without a pelvic lymph node dissection. Subjects receive a single dose of 99mTc-MIP-1404 followed by whole body planar and SPECT/CT pelvic imaging. Radical prostatectomy or prostate biopsy occurred within 42 days of 99mTc-MIP-1404 dosing...