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Phase 2 Randomized Trial Evaluating Satraplatin Plus Tarceva


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GPC Biotech Initiates Phase 2 Randomized Trial Evaluating Satraplatin Plus Tarceva® In Patients With Advanced Non-Small Cell Lung Cancer

03 Aug 2006

GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced the initiation of a Phase 2 randomized trial evaluating the Company's lead drug candidate, satraplatin, in combination with Tarceva® (erlotinib) as a first-line therapy in patients with inoperable advanced non-small cell lung cancer (NSCLC) who are 70 years of age and older. A Phase 3 registrational trial exploring satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer has completed patient enrollment. GPC Biotech continues to open additional clinical studies to explore the potential of satraplatin in a variety of tumor types.

The Phase 2 study in advanced NSCLC is a randomized trial that is expected to involve over 20 centers in the U.S. and Europe and enroll approximately 120 patients. The primary objective of this study is to evaluate progression-free survival. The study will also examine overall survival, response rates and safety.

"Platinum-based combination therapies are often used to treat patients with advanced non-small cell lung cancer. However, elderly patients are frequently not treated with standard chemotherapy due to concerns about their ability to tolerate treatment," said Marcel Rozencweig, M.D., Senior Vice President, Drug Development and Chief Medical Officer. "A combination regimen of satraplatin -- an oral, well-tolerated platinum-based compound -- in combination with another oral, well-tolerated drug such as Tarceva could, if effective, offer an important new treatment option for this under-served patient group."

Patients in the Phase 2 trial will be randomized to receive satraplatin plus Tarceva or Tarceva alone. A sequential dosing regimen will be used in the satraplatin arm. The treatment cycle for both arms is 28 days. Patients will be stratified according to smoking history and gender.

About Lung Cancer

Lung cancer is the leading cause of cancer death in the U.S., with an estimated 162,000 deaths expected from the disease in 2006. Over 170,000 new cases are expected to be diagnosed in 2006. The five-year survival rate for lung cancer in the U.S. is only 15 percent. Recent statistics for Europe estimated over 375,000 cases annually of lung cancer and over 345,000 deaths from the disease. NSCLC accounts for over 80% of all lung cancer cases, and over 50% of patients present with inoperable disease.

Standard first-line chemotherapy for patients with advanced NSCLC typically involves a combination regimen, frequently with a platinum-based therapy. For elderly patients or patients with a poor performance status, a single-agent chemotherapy may be recommended due to concerns about these patients' ability to tolerate a combination regimen. Thus, there is a need for well-tolerated, effective combination treatments.

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 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. The Company has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been 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 http://www.gpc-biotech.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 http://www.gpc-biotech.com/.

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