Data on pre-clinical activity of satraplatin in prostate cancer to be released

Mar 29 2004

Spectrum Pharmaceuticals, Inc has announced that new data on pre-clinical activity of satraplatin in prostate cancer cell lines are being presented at the 95th Annual Meeting of the American Association for Cancer Research (AACR) in Orlando, Florida. Spectrum Pharmaceuticals' co-development partner for satraplatin, GPC Biotech AG, will present abstract #4614 entitled "Cytotoxic activity of satraplatin (JM216) and its metabolites in human prostate carcinoma cell lines" on March 30, 2004. "The data on satraplatin, to be presented at one of the key scientific meetings in the field of cancer research, continues to be supportive of the clinical development of satraplatin for the treatment of hormone-refractory prostate cancer," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc.

Satraplatin was tested in three human prostate cancer cell lines, two androgen-independent (i.e., hormone refractory) and one androgen-sensitive (i.e., hormone sensitive). Investigators concluded that satraplatin was a potent cytotoxic agent in prostate cancer. Hormone refractory prostate cancer cell lines were more sensitive to satraplatin than the hormone sensitive cell line.

About satraplatin

Satraplatin is a member of the platinum family of compounds, but unlike platinum compounds currently on the market, satraplatin is orally administered. A registrational phase 3 trial, the SPARC (Satraplatin and Prednisone Against Refractory Cancer) trial, for satraplatin in hormone-refractory prostate cancer (HRPC) was initiated in September 2003 following successful completion of an Special Protocol Assessment by the U.S. Food and Drug Administration (FDA). Also in September 2003, the FDA granted fast track designation to satraplatin as a second-line chemotherapy for patients with HRPC. In February 2004, GPC Biotech AG announced the receipt of a Scientific Advice Letter from the European Agency for the Evaluation of Medicinal Products enabling the Phase 3 registrational trial on satraplatin to proceed in Europe using the SPARC trial. Results from a randomized, 50-patient study in HRPC were presented at the American Society of Clinical Oncology Annual Meeting in June 2003. These data demonstrated statistically significant improvement in time to disease progression and doubling of progression-free survival in the satraplatin-treated group compared to the control group. Phase 2 trials have been completed in HRPC, as well as in other tumor types, including ovarian and small-cell lung cancer. Further information on satraplatin can be found in the "Products" section of the Spectrum Pharmaceuticals' Web site at http://www.spectrumpharm.com.