Cytogen gets FDA clearance for prostate treatment CYT-500

By Elaine Rigoli

Tampa, Fla., May 8 - Cytogen Corp. said the Food and Drug Administration has cleared an Investigational New Drug application for CYT-500, a candidate designed to enable targeted delivery of a cytotoxic agent to PSMA-expressing cells.

PSMA is a protein abundantly expressed on the surface of prostate cancer cells, with an increased expression in high-grade cancers, metastatic disease and hormone-refractory prostate cancer.

Cytogen expects to begin the first phase 1 clinical trial of CYT-500 in patients with hormone-refractory prostate cancer subject to Institutional Review Board approval at the planned clinical site, according to a news release.

"This regulatory clearance by the FDA is an important step in our efforts to develop CYT-500. 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," president and chief executive officer Michael D. Becker said in a statement.

Cytogen retains full and exclusive development rights to CYT-500.

Cytogen is a biopharmaceutical company located in Princeton, N.J.

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