Independent Data Monitoring Board Recommends that Satraplatin Phase 3 Trial Continue as Planned
June 8, 2006
- Full Progression Free Survival Data Expected in Fall 2006 -
Martinsried/Munich (Germany), Waltham, Mass., Princeton, N.J., and Boulder, Colo. –GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) and Pharmion Corporation (NASDAQ: PHRM) today announced that the independent Data Monitoring Board (DMB) for the satraplatin Phase 3 registrational trial SPARC (Satraplatin and Prednisone Against Refractory Cancer) in second-line chemotherapy for hormone-refractory prostate cancer has held a meeting to review an interim analysis of overall survival data from the study. The DMB recommended the trial continue as planned, per protocol.
No safety concerns were raised by the DMB, and they recommended that the trial continue as planned, without changes. The SPARC trial, therefore, continues to completion and GPC Biotech and Pharmion remain blinded to the study data. As previously communicated, the companies expect the full progression free survival (PFS) data to be available in the fall of this year. PFS 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 PFS results from the trial this fall. If the data are positive, we anticipate completing the NDA filing by the end of 2006, and we expect that Pharmion will file its MAA with the European regulatory authorities in the first quarter of 2007,” said Marcel Rozencweig, M.D., Senior Vice President, Drug Development and Chief Medical Officer of GPC Biotech. “In parallel to completing the registrational trial, we will continue to initiate additional clinical trials with satraplatin in other cancer indications and in combination with other anticancer treatments.”
About the Data Monitoring Board
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 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 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.
In December 2005, GPC Biotech completed accrual to the SPARC trial that is evaluating satraplatin in combination with prednisone as second-line chemotherapy in patients with hormone refractory prostate cancer. Also in December 2005, GPC Biotech initiated the rolling submission of an NDA for satraplatin with the FDA and 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.
Satraplatin has been studied in clinical trials involving a range of tumors, 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. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002. Additional information on satraplatin can be found in the Anticancer Programs section of the Company’s Web site at www.gpc-biotech.com.
Pharmion is a biotechnology company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients in the U.S., Europe and additional international markets. Pharmion has a number of products on the market including the world’s first approved epigenetic therapy, Vidaza®, a DNA demethylating agent. For additional information about Pharmion, please visit the company’s website at www.pharmion.com.
About GPC Biotech
GPC Biotech AG is a biopharmaceutical company discovering and developing new anticancer drugs. The Company’s lead product candidate – satraplatin – has achieved target enrollment in a Phase 3 registrational trial as a second-line chemotherapy treatment in hormone-refractory prostate cancer. The U.S. FDA has granted fast track designation to satraplatin for this indication, and GPC Biotech has begun the rolling NDA submission process for this compound. GPC Biotech is also developing a monoclonal antibody with a novel mechanism-of-action against a variety of lymphoid tumors, currently in Phase 1 clinical development, and has ongoing drug development and discovery programs that leverage its expertise in kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich (Germany). The Company’s wholly owned U.S. subsidiary has sites in Waltham, Massachusetts and Princeton, New Jersey. For additional information, please visit the Company’s Web site at www.gpc-biotech.com.
This press release may contain forward-looking statements, including, without limitation, statements about the progress and results of the outcome of the SPARC trial and other clinical development activities, regulatory processes and commercialization efforts for satraplatin. Forward-looking statements are based on the Company’s current expectations and projections about future events and are subject to risks, uncertainties and assumptions in light of which the forward-looking events discussed in this press release might not occur. We direct you to the Company’s Form 20-F for the fiscal year ended December 31, 2005 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect these statements and the Company’s future results, performance and achievements. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Except as required by law, the Company does not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For further information, please contact:
For GPC Biotech AG:
82152 Martinsried/Munich, Germany
Associate Director, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565-2693
In the U.S.: Laurie Doyle
Associate Director, Investor Relations & Corporate Communications
Phone: +1 781 890 9007 X267
For Pharmion Corporation:
Breanna Burkart/Anna Sussman
Directors, Investor Relations and Corporate Communications
Phone: +1 720 564 9144
- Contact Information
- Laurie Doyle
- Associate Director, Investor Relations & Corporate Communications
- GPC Biotech AG
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