Prostate
Satraplatin for its Use in Second-Line Treatment for Hormone Refractory Prostate Cancer Continues in Phase 3
By Spectrum Pharmaceuticals, Inc.
Apr 20, 2005, 09:30

Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced that its co-development partner for satraplatin, GPC Biotech AG (Nasdaq: GPCB) (Frankfurt Stock Exchange: GPC), disclosed that the independent Data Monitoring Board (DMB) for the satraplatin Phase 3 SPARC registrational trial in second-line hormone refractory prostate cancer held a meeting on April 18, 2005 to review safety data from the ongoing study. The DMB reviewed the safety data from the first 262 patients who were randomized in the trial and had completed at least one cycle of treatment. After reviewing the data, the DMB reported that the design and conduct of the trial remain sound and recommended that the trial continue as planned.

As previously reported, GPC Biotech remains on schedule to complete patient enrollment in the SPARC trial by the end of 2005 and to complete the NDA (New Drug Application) filing with the U.S. FDA in the second half of 2006.

About Satraplatin

Satraplatin, an investigational drug, is a member of the platinum family of compounds. Over the past two decades, platinum-based drugs have become a critical part of modern chemotherapy treatments and are used to treat a wide
variety of cancers.

Worldwide sales of these drugs exceeded $2.2 billion in
2004. Unlike the platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications.

Additionally, satraplatin is the only platinum-based compound to have shown efficacy in a randomized clinical
trial in prostate cancer. Prostate cancer is the most common cancer among men in the U.S. and Europe. The number of patients with this disease is expected to increase with the aging population. As the disease advances, patients are
often treated with hormone therapy. Once patients fail hormone therapy, becoming hormone-refractory, follow-on treatment involves a limited number of options, including chemotherapy.

For patients who then fail first-line chemotherapy, there are currently no approved second-line chemotherapy regimens. Satraplatin is in a Phase 3 registrational trial -- the SPARC trial -- as a second-line chemotherapy treatment for HRPC.

GPC Biotech has successfully completed a Special Protocol Assessment with the U.S. FDA and has
received a Scientific Advice letter from the European regulatory authority, the European Medicines Agency (EMEA). The FDA has also granted fast track designation to satraplatin for this indication.

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