MARTINSRIED/MUNICH, Germany, May 16 /PRNewswire-FirstCall/ -- WALTHAM, Mass. and PRINCETON, N.J. -- GPC Biotech AG today announced that a Phase 1 study evaluating the Company's lead drug candidate, satraplatin, in combination with Xeloda(R) (capecitabine) in patients with advanced solid tumors has opened for accrual. Xeloda is an oral form of 5-FU, a marketed chemotherapy treatment that is used to treat various cancers, including metastatic breast and colorectal cancers.
The Phase 1 study is an open label study being conducted at Northwestern University Medical Center in Chicago under the direction of William Gradishar, M.D., Professor of Medicine, Director Breast Medical Oncology. The primary objective of this study is to determine the maximum tolerated dose for satraplatin in combination with Xeloda in patients with advanced solid tumors. The trial is expected to enroll up to 24 patients.
Dr. Gradishar commented: "Combinations of intravenous 5-FU and certain marketed platinum compounds have shown activity in a number of cancers. I am excited about the potential that the combination of satraplatin and Xeloda may hold. This oral-oral regimen, if effective, may offer doctors an important new, well tolerated and convenient treatment option for patients with a variety of cancers."
"We are pleased to be working with Dr. Gradishar and his team at Northwestern. Dr. Gradishar is a distinguished medical oncologist whose research has been instrumental in developing novel anticancer therapies," said Marcel Rozencweig, M.D., Senior Vice President, Drug Development and Chief Medical Officer of GPC Biotech. "This is the first study we have opened that is evaluating satraplatin in an oral-oral combination, and additional such trials are planned. An all-oral regimen holds the possibility of enabling patients to take their treatments at home instead of being treated at the hospital."
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.
Xeloda(R) (capecitabine) is a registered trademark of Hoffmann-La Roche AG.
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.: Euro RSCG Life NRP 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 AGCONTACT: 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//
