Pharmion, GPC Biotech, Spectrum: Monitoring board recommends satraplatin phase 3 trial continue

By E. Janene Geiss

Philadelphia, June 8 - Pharmion Corp., GPC Biotech AG and Spectrum Pharmaceuticals, Inc. said Thursday that the independent data monitoring board for the satraplatin phase 3 registrational trial Sparc (Satraplatin and Prednisone Against Refractory Cancer) in second-line chemotherapy for hormone-refractory prostate cancer has recommended that the trial continue as planned.

The monitoring board held a meeting to review an interim analysis of overall survival data from the study, according to a company news release.

No safety concerns were raised by the board and it recommended that the trial continue as planned without changes.

The trial, therefore, continues to completion, officials said.

Spectrum, GPC Biotech and Pharmion remain blinded to the study data.

The full progression-free survival data should be available in the fall of 2006, officials said.

Progression-free survival remains the end-point of the Sparc trial for accelerated approval in the United States and is also the basis, along with supporting overall survival data, for approval in Europe.

If the data are positive, Spectrum said it anticipates filing a New Drug Application by the end of 2006.

In the meantime, officials said additional clinical trials with satraplatin will be started in other cancer indications and in combination with other anticancer treatments.

Satraplatin is an orally bioavailable investigational drug and member of the platinum family of compounds.

Spectrum out-licensed satraplatin to GPC Biotech AG in 2002, and GPC Biotech fully funds all development expenses. In December 2005, GPC Biotech signed a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corp., under which Pharmion was granted exclusive commercialization rights to satraplatin for Europe and certain other territories outside the United States.

Spectrum is a specialty pharmaceutical company based in Irvine, Calif.

Pharmion is a Boulder, Colo., biotechnology company focused on hematology and oncology products.

GPC Biotech is a Munich, Germany, biopharmaceutical company focused on anticancer drugs.

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