GPC Biotech Presents New Satraplatin Clinical Data from Two Pharmacokinetics Studies at ASCO
June 6, 2006
Martinsried/Munich (Germany), and Waltham, Mass. and Princeton, N.J., – GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) today announced the presentation of new clinical data on its lead drug candidate satraplatin, currently in a fully enrolled Phase 3 trial, at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia.
A poster entitled, “Phase 1 Study of the Effects of Hepatic Impairment on the Pharmacokinetics (PK) and Safety of Satraplatin in Patients with Refractory Non-Hematologic Cancer,” presented study data on 19 patients with advanced solid tumors and with varying degrees of hepatic impairment (reduced liver function). The study was designed to show the effect of hepatic impairment on the pharmacokinetics of satraplatin in patients with advanced forms of cancer. Most patients in the study were heavily pre-treated. As this study is still ongoing, the data reported are considered preliminary. Satraplatin appears to be well tolerated in patients with mild to moderate liver impairment. As expected, the main toxicities observed thus far have been hematologic – anemia, thrombocytopenia (decrease in platelets in the blood) and neutropenia (decrease in white blood cells). Non-hematologic toxicities like diarrhea, anorexia, and fatigue have been mild. No significant cardio-, liver or neurological toxicities have yet been observed.
A second poster entitled, “Phase 1 Study of the Effects of Renal Impairment on the Pharmacokinetics and Safety of Satraplatin in Patients with Refractory Non-Hematologic Cancer,” presented study data on 24 patients with advanced solid tumors and with varying degrees of renal impairment (reduced kidney function). The study was designed to show the effect of renal impairment on the pharmacokinetics of satraplatin in patients with advanced forms of cancer. As this study is still ongoing, the data reported are considered preliminary. Satraplatin appears to be well tolerated in these patients. As expected, the main hematological toxicities observed to date have been anemia and thrombocytopenia. Common toxicities like nausea, vomiting, diarrhea, fatigue and anorexia have to date been mild. No significant cardio-, renal, liver or neurological toxicities have yet been observed.
As patients with advanced cancer may often have limited function of the liver and/or kidneys, it is important to understand how these impairments affect how a drug is used by the body. The results of these two studies should help clinicians understand the tolerability and appropriate dosing of satraplatin in cancer patients whose liver or kidney function are compromised.
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 a New Drug Application (NDA) for satraplatin with the U.S. Food and Drug Administration (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.
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:
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
Additional Media Contacts:
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Phone: +44 (0)20 7379 5151
In the U.S.:
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