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Cytogen's Lu-177-7E11 for prostate cancer remains on track for first-quarter 2006 IND application
By Angela McDaniels
Seattle, Nov. 15 - Cytogen Corp. said preclinical data for its prostate cancer therapeutic product candidate Lu-177-7E11 in mice showed the antibody-radionuclide linkage of Lu-177-7E11 is stable in serum and successfully accumulates at tumor sites.
Lu-177-7E11 is a therapeutic radioisotope attached to the monoclonal antibody 7E11.C5.3, used in Cytogen's Prostascint (capromab pendetide) molecular imaging agent, that delivers radiation to tumor cells.
Toxicology studies in rats and dogs and safety pharmacology studies in dogs did not reveal any significant adverse reactions with unlabeled doses up to 20 times the anticipated human dose, the company said.
The company said it plans to file an Investigational New Drug Application for the product candidate in the first quarter of 2006.
"Lu-177-7E11 has the potential to be an effective agent for the treatment of prostate cancer and builds on the well-established expression of prostate-specific membrane antigen and the effective targeting of this unique antigen with our 7E11 antibody as evidenced by Prostascint," president and chief executive officer Michael D. Becker said in a company press release.
The data was presented Tuesday at the American Association for Cancer Research, National Cancer Institute and European Organization for Research and Treatment of Cancer International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.
Cytogen is biopharmaceutical company based in Princeton, N.J., that develops molecules used to target the sites and stages of cancer progression.
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