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DMB recommends to continue phase 3 trial of Spectrum's satraplatin

Irvine, CaliforniaMonday, June 12, 2006, 08:00 Hrs  [IST]

Spectrum Pharmaceuticals, Inc., a specialty pharmaceutical company based in Irvine, California, announced that the independent Data Monitoring Board (DMB) held a meeting to review an interim analysis of overall survival data from the satraplatin phase 3 registrational trial SPARC (Satraplatin and Prednisone Against Refractory Cancer) in second-line chemotherapy for hormone-refractory prostate cancer. The DMB recommended the trial continue as planned, per protocol. No safety concerns were raised by the DMB, and it recommended that the trial continue as planned, without changes. The trial, therefore, continues to completion. Spectrum, GPC Biotech and Pharmion remain blinded to the study data. As previously communicated, the full progression free survival data should be available in the fall of 2006. Progression free survival remains the endpoint of the SPARC trial for accelerated approval in the U.S. and is also the basis, along with supporting overall survival data, for approval in Europe. "We look forward to reporting the final progression free survival results from the trial this fall. If the data are positive, we anticipate the NDA filing will be completed by the end of 2006," said Dr. Luigi Lenaz, chief scientific officer of Spectrum. "In the meantime, additional clinical trials with satraplatin will be initiated in other cancer indications and in combination with other anti-cancer treatments." The Data Monitoring Board consists of independent oncology and statistical experts whose primary responsibility is to monitor, on a periodic basis, the data from the SPARC trial and to provide recommendations to Spectrum, GPC Biotech and Pharmion on whether the study should proceed as originally planned, be modified or be discontinued. Members of the Data Monitoring Board are independent from Spectrum, GPC Biotech and Pharmion and also do not participate as clinical investigators in the SPARC trial. 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. 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. Spectrum out-licensed satraplatin to GPC Biotech AG in 2002, and GPC Biotech fully funds all development expenses. In December 2005, the accrual to the SPARC trial was completed and the rolling submission of a New Drug Application (NDA) for satraplatin with the U.S. Food and Drug Administration (FDA) was initiated. Also in December 2005, GPC Biotech signed a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion was granted exclusive commercialization rights to satraplatin for Europe and certain other territories outside the US. Satraplatin has been studied in clinical trials involving a range of tumours, and Phase 2 trials have been completed in hormone-refractory prostate cancer, ovarian cancer and small cell lung cancer. Other trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in various other cancers are underway or planned.

 
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