Cytogen Corporation has announced the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for CYT-500, the company's lead therapeutic candidate targeting prostate-specific membrane antigen (PSMA).
Cytogen expects to begin the first U.S. Phase I clinical trial of CYT-500 in patients with hormone-refractory prostate cancer subject to Institutional Review Board (IRB) approval at the planned clinical site.
CYT-500 uses the same monoclonal antibody from Cytogen's ROSTASCINT® (capromab pendetide) molecular imaging agent, but is linked through a higher affinity linker than is used for PROSTASCINT to a therapeutic as opposed to an imaging radionuclide.
This 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.
"This regulatory clearance by the FDA is an important step in our efforts to develop CYT-500," stated Michael D. Becker, president and chief executive officer of Cytogen.
"In a very short period of time, we have produced clinical quality drug and have received regulatory clearance to proceed with clinical trials, which we expect to initiate soon after IRB approval."
"As a pioneer in PSMA-related research and development, these are significant steps forward for Cytogen that expand our focus on developing and commercializing novel therapeutic oncology products."