SOURCE: GPC Biotech

November 02, 2005 04:15 ET

GPC Biotech Announces Start of Phase 2 Trial Evaluating Satraplatin in Patients With Metastatic Breast Cancer

MARTINSRIED/MUNICH, GERMANY -- (MARKET WIRE) -- November 2, 2005 -- U.S. Research and Development Facilities in Waltham/Boston, MA and Princeton, NJ -- GPC Biotech AG (Frankfurt: GPC) (TecDAX index) (NASDAQ: GPCB) today announced that a Phase 2 study evaluating the Company's lead drug candidate, satraplatin, in patients with metastatic breast cancer who have received no more than one prior chemotherapy treatment regimen, has opened for accrual. The study is being managed by US Oncology. Satraplatin is currently in a Phase 3 registrational trial as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer. The Company is also opening new clinical studies to explore the potential of satraplatin in a number of additional tumor types.

The Phase 2 study in metastatic breast cancer is an open label, multicenter study being managed by US Oncology, a leading healthcare services network dedicated exclusively to cancer treatment and research. Fifty-seven research sites in the US Oncology Network plan to participate in this trial. The primary objective of this study is to determine the objective response rate of satraplatin in this patient population. The study is expected to enroll 80 patients.

"Despite advancements in treating breast cancer, it is important to continue to find and develop effective therapies, as patients with advanced disease often do not respond to existing treatments or will eventually relapse," said Joyce O'Shaughnessy, M.D., Co-Director of US Oncology's Breast Cancer Research Committee and Director, Breast Cancer Prevention at Baylor-Charles A. Sammons Cancer Center in Dallas, Texas. "Satraplatin, as an oral drug that is relatively well tolerated, could provide an additional option for these patients. I look forward to exploring the compound's potential in this disease setting."

Marcel Rozencweig, M.D., Senior Vice President, Drug Development of GPC Biotech said, "We are pleased to have Dr. O'Shaughnessy and US Oncology participate in this study. Dr. O'Shaughnessy is a leader in the field of breast cancer research and treatment. She is an experienced investigator who has published and spoken widely on new prevention and treatment strategies for breast cancer. The US Oncology Research Network has extensive experience in conducting all phases of clinical trials and has significant expertise in breast cancer research."

Breast cancer is the leading cause of cancer-related death among women in Europe, and in the U.S., it is second only to lung cancer. In 2005, it is estimated that over 210,000 new cases of invasive breast cancer will be diagnosed and over 40,000 women are expected to die from the disease in the U.S. The numbers are even higher in the European Union, with an estimated 270,000 new cases of the disease diagnosed annually and 88,000 deaths. While today in the U.S. the 5-year relative survival rate for localized breast cancer is 98%, the figure for patients with distant metastases is 26%.

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. Worldwide sales of these drugs exceeded $2.2 billion in 2004. 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. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications. Satraplatin is in a Phase 3 registrational trial -- the SPARC trial -- as a second-line chemotherapy treatment for hormone-refractory prostate cancer (HRPC). GPC Biotech has completed a Special Protocol Assessment with the U.S. FDA and has received a Scientific Advice letter from the European regulatory authority, the European Medicines Agency (EMEA). The FDA has also granted fast track designation to satraplatin for this indication.

Phase 2 trials have been completed in HRPC, ovarian cancer and small-cell lung cancer. Promising early clinical results have also been shown when satraplatin is combined with radiation therapy, and a Phase 1/2 study evaluating this combination in patients with non-small cell lung cancer has been initiated. A Phase 1 study evaluating satraplatin in combination with TAXOTERE® (docetaxel) in patients with advanced solid tumors is also underway. Additional studies evaluating satraplatin in combination with other therapies in various cancers are planned. Further information on satraplatin can be found in the Anticancer Programs section of the Company's Web site at www.gpc-biotech.com.

About US Oncology

US Oncology, headquartered in Houston, Texas, is one of the nation's largest healthcare services networks dedicated exclusively to cancer treatment and research. US Oncology network practices are provided with unparalleled opportunities to participate in the ongoing clinical research and development of the newest promising cancer therapies. The network is currently involved in approximately 77 research trials that are open for enrollment and has contributed to the development of 23 of 29 of the latest cancer-fighting drugs approved by the FDA for use. Since initiation of the network, more than 29,000 patients have participated in clinical trials that have been managed by the US Oncology Network. US Oncology is affiliated with 985 physicians operating in 494 locations, including 97 radiation oncology facilities in 33 states. For more information visit, www.usoncology.com.

About GPC Biotech

GPC Biotech AG is a biopharmaceutical company discovering and developing new anticancer drugs. The Company's lead product candidate -- satraplatin -- is currently in a Phase 3 registrational trial as a second-line chemotherapy treatment in hormone-refractory prostate cancer following completion of a Special Protocol Assessment by the U.S. FDA and receipt of a Scientific Advice letter from the European central regulatory authority, EMEA. The FDA has also granted fast track designation to satraplatin for this indication. Other anticancer programs include: a monoclonal antibody with a novel mechanism-of-action against a variety of lymphoid tumors, currently in Phase 1 clinical development, and a small molecule broad-spectrum cell cycle inhibitors program, currently in pre-clinical development. The Company also has a number of drug discovery programs that leverage its expertise in kinase inhibitors. GPC Biotech has a multi-year alliance with ALTANA Pharma AG working with the ALTANA Research Institute in the U.S., which provides GPC Biotech with revenues through mid-2007. GPC Biotech AG is headquartered in Martinsried/Munich (Germany). The Company's wholly owned U.S. subsidiary has research and development 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 projections or estimates relating to plans and objectives relating to our future operations, products, or services; future financial results; or assumptions underlying or relating to any such statements; each of which constitutes a forward-looking statement subject to risks and uncertainties, many of which are beyond our control. Actual results could differ materially depending on a number of factors, including the timing and effects of regulatory actions, the results of clinical trials, the Company's relative success developing and gaining market acceptance for any new products, and the effectiveness of patent protection. There can be no guarantee that the SPARC trial will be completed nor that satraplatin will be approved for marketing in a timely manner, if at all. In addition, there can be no guarantee regarding the results of the satraplatin Phase 2 study in patients with metastatic breast cancer. We direct you to the Company's Annual Report on Form 20-F, as amended, for the fiscal year ended December 31, 2004 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the Company's future results, performance and achievements. The Company disclaims any intent or obligation to update these forward-looking statements or the factors that may affect the Company's future results, performance or achievements, even if new information becomes available in the future.

TAXOTERE® (docetaxel) is a registered trademark of the sanofi-aventis group.

Contact Information

  • 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 for GPC Biotech:

    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

    US Oncology contact:
    Kimberly Rutherford
    Director, Corporate Communications
    Phone: +1 832-601-6193
    Kimberly.Rutherford@usoncology.com