US FDA clears IND for Cytogen's CYT-500

US drugmaker Cytogen Corp says that the Food and Drug Administration has cleared an Investigational New Drug application for CYT-500, its lead therapeutic candidate targeting prostate-specific membrane antigen.

Cytogen expects to begin the first domestic Phase I clinical trial of the agent in patients with hormone-refractory prostate cancer, shortly, subject to Institutional Review Board approval at the planned clinical site.

The agent uses the same monoclonal antibody as Cytogen's Prostacint (capromab pendetide) molecular imaging agent, but is linked through a higher affinity linker than is used for a therapeutic as opposed to an imaging radionuclide and is designed to enable targeted delivery of a cytotoxic agent to PSMA-expressing cells.