ORLANDO, Fla. -- Results of a new study strongly suggest that DN-101, a new high-dose calcitriol pill designed specifically as a cancer therapy, given in combination with docetaxel (Taxotere) extends the lives of men with advanced prostate cancer. And, the toxicity of the combination therapy proved to be no greater than for research subjects who received docetaxel alone. Calcitriol is a naturally occurring hormone and the biologically active form of vitamin D.

"The data strongly suggest that DN-101, given in combination with docetaxel, will provide a substantial survival benefit to prostate cancer patients without adding toxicity," said Tomasz Beer, M.D., national leader of the clinical trial and director of the Prostate Cancer Program in the Oregon Health & Science University Cancer Institute. "While we've known about the anti-tumor potential of vitamin D, toxicity has been a significant issue to be overcome in making it a successful part of prostate cancer therapy."

Results from the study, the AIPC Study of Calcitriol Enhancing Taxotere (ASCENT), were presented on Sunday, May 15, at the 41st annual meeting of the American Society for Clinical Oncologists in Orlando, Fla. Christopher Ryan, M.D, member of the OHSU Cancer Institute, served as principal investigator at the OHSU study site. The study was supported by Novacea Inc., maker of DN-101, in collaboration with Sanofi-Aventis, maker of Taxotere.

ASCENT is a randomized, double-blinded, placebo-controlled clinical trial to evaluate DN-101 in combination with docetaxel for advanced prostate cancer research subjects who are no longer responding to hormonal therapy, a condition known as androgen-independent prostate cancer (AIPC). Two hundred fifty subjects participated in the study at 48 sites between September 2002 and January 2004.

Researchers estimate that subjects receiving DN-101 in combination with docetaxel survive 7.1 months longer than those who received doceta
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Contact: Rachel MacKnight
macknigh@ohsu.edu
503-494-8231
Oregon Health & Science University
16-May-2005

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