Cytogen Corp. submitted an IND application to the FDA for CYT-500, the company’s lead therapeutic candidate targeting prostate-specific membrane antigen (PSMA). Subject to FDA acceptance and Institutional Review Board (IRB) approval at the planned clinical site, Cytogen expects to begin the first U.S. Phase I trial of CYT-500 in patients with hormone-refractory prostate cancer.

CYT-500 incorporates the same monoclonal antibody utilized in Cytogen’s Prostascint molecular imaging agent, but is linked to a therapeutic as opposed to an imaging payload. This novel product candidate is designed to enable targeted delivery of a cytotoxic agent to PSMA-expressing cells. Cytogen retains full and exclusive development rights to CYT-500.