Cytogen submits Investigational New Drug application for CYT-500 to treat metastatic prostate cancer

By E. Janene Geiss

Philadelphia, April 6 - Cytogen Corp. announced Thursday the submission of an Investigational New Drug application to the Food and Drug Administration for CYT-500, the company's lead therapeutic candidate targeting prostate-specific membrane antigen.

Subject to FDA acceptance and Institutional Review Board approval at the planned clinical site, Cytogen said it expects to begin the first U.S. phase 1 clinical trial of CYT-500 in patients with hormone-refractory prostate cancer, according to a company news release.

CYT-500 incorporates the same monoclonal antibody used in Cytogen's Prostascint (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 prostate-specific membrane antigen-expressing cells. Cytogen said it retains full and exclusive development rights to CYT-500.

"The submission of this IND for CYT-500 within a year of initiating the development program is a significant step forward for Cytogen as we seek to expand our focus on developing and commercializing a broader range of therapeutic oncology products," Michael D. Becker, president and chief executive officer of Cytogen, said in the release.

Prostate-specific membrane antigen 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.

It also is present at high levels on the newly formed blood vessels, or neovasculature, needed for the growth and survival of many solid tumors.

Cytogen is a Princeton, N.J., biopharmaceutical company dedicated to improving the lives of patients with cancer by acquiring, developing and commercializing innovative molecules targeting the sites and stages of cancer progression.

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