* Data Monitoring Board Reports Design and Conduct of Trial Remain Sound * SPARC Trial Passes Futility Analysis * Full Progression Free Survival Data Expected in Fall 2006
MARTINSRIED/MUNICH (Germany) April 25 /PRNewswire-FirstCall/ -- WALTHAM, Mass. and PRINCETON, N.J. -- GPC Biotech AG 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 its planned meeting to review interim safety and efficacy data from the study. As expected, the DMB recommended that the trial should continue to completion.
The DMB analyzed the efficacy data as assessed by the blinded independent progression review panel on the first 354 progression-free survival (PFS) events and also reviewed the safety data from the first 593 patients who had been 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 remained sound. In addition, the DMB determined that the SPARC trial had also passed the pre-defined futility analysis. The SPARC trial, therefore, continues to completion and GPC Biotech remains blinded to the study data.
“We are delighted that the independent Data Monitoring Board made this recommendation and that satraplatin passed the futility analysis,” said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. “The results of this planned interim analysis are as expected -- namely that the Board has recommended that the SPARC trial continue to its completion. We look forward to reporting the final PFS results from the trial this fall and, if the data are positive, we anticipate completing the NDA filing by the end of 2006. 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 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 also do not participate as clinical investigators in the SPARC trial.
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. 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 and initiated the rolling submission of a New Drug Application (NDA) for satraplatin with the U.S. Food and Drug Administration (FDA). 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.
Satraplatin has been studied in clinical trials involving a range of tumors, and Phase 2 trials have been completed in HRPC, 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 http://www.gpc-biotech.com.
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 http://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: GPC Biotech AG Fraunhoferstr. 20 82152 Martinsried/Munich, Germany Martin Braendle Associate Director, Investor Relations & Corporate Communications Phone: +49 (0)89 8565-2693 ir@gpc-biotech.com In the U.S.: Laurie Doyle Associate Director, Investor Relations & Corporate Communications Phone: +1 781 890 9007 X267 usinvestors@gpc-biotech.com Additional Media Contacts: In the U.S.: Noonan Russo Matt Haines Phone: +1 212 845 4235 matthew.haines@eurorscg.com In Europe: Maitland Noonan Russo Brian Hudspith Phone: +44 (0)20 7379 5151 bhudspith@maitland.co.uk
GPC Biotech AG
CONTACT: Martin Braendle, Associate Director, Investor Relations &Corporate Communications, +49 (0)89 8565-2693, ir@gpc-biotech.com, orLaurie Doyle, Associate Director, Investor Relations & CorporateCommunications, +1-781-890-9007 ext. 267, usinvestors@gpc-biotech.com, bothof GPC Biotech AG; or In the U.S.: Matt Haines of Euro RSCG Life NRP,+1-212-845-4235, matthew.haines@eurorscg.com; or In Europe: Brian Hudspithof Maitland Noonan Russo, +44 (0)20 7379 5151, bhudspith@maitland.co.uk
Web site: http://www.gpc-biotech.com/
