Cytogen submits IND for CYT-500 to US FDA

New Jersey, USA-based cancer specialist Cytogen has submitted an Investigational New Drug application to the Food and Drug Administration for CYT-500, its lead therapeutic candidate targeting prostate-specific membrane antigen. Subject to its acceptance and Institutional Review Board approval at the planned clinical site, the firm expects to begin the first US Phase I trial in patients with hormone- refractory prostate cancer.

The agent incorporates the same monoclonal antibody utilized in Cytogen's Prostacint (capromab pendetide) 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 noted that it retains full and exclusive development rights to CYT-5.