GPC Biotech Presents New Satraplatin Clinical Data from Pharmacokinetics Study at ASCO Prostate Cancer Symposium
New preclinical data on efficacy of satraplatin in prostate cancer cells and with Taxotere® also presented
Martinsried/Munich (Germany), and Waltham, Mass. and Princeton, N.J., February 27, 2006 – GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index; NASDAQ: GPCB) today announced the presentation of new clinical and preclinical data on its lead drug candidate satraplatin at the ASCO Prostate Cancer Symposium: A Multidisciplinary Approach in San Francisco, California.
A poster entitled, “A Phase 1 Pharmacokinetic (PK)/Food Effect and Safety Study of Satraplatin,” presented data from a study involving seventeen patients with advanced solid tumors. Most patients in the study were heavily pre-treated: the median number of prior chemotherapy treatments was three. Satraplatin appeared to be well tolerated, with no significant cardio-, renal, liver or neurological toxicities observed. Other common toxicities like nausea, vomiting and diarrhea were mild to moderate and were reported to be controlled with prophylactic oral anti-emetic therapy. Seven patients in the study had hormone-refractory prostate cancer (HRPC), and all of the HRPC patients had received Taxotere® (docetaxel), with a median of three prior chemotherapy regimens. Satraplatin showed evidence of anti-tumor activity in this group: one patient had a partial response (RECIST criteria), and two patients had prolonged stable disease (durations of 3.5 and five months).
The study was designed to evaluate the effect of food on the bioavailability (i.e., the rate at which the drug is absorbed and the amount of drug absorbed) of satraplatin. Such data are useful in determining the best way for patients to take an oral drug. In this study, the peak plasma concentrations of satraplatin were decreased by approximately 20% following a high fat meal; however, the total amount of drug absorbed was not affected by food. The clinical implications of the reduced peak drug concentrations in the face of equivalent total amounts of drug absorbed in patients taking satraplatin following a high fat meal are not known.
A second poster entitled, “Efficacy of Satraplatin, an Oral Platinum Analogue in Prostate Cancer: Synergistic Activity with Docetaxel,” reviewed the preclinical results of studies evaluating the cell-killing effect of satraplatin and its metabolite on prostate cancer cells. In vivo and in vitro data showed that satraplatin and its active metabolite, JM-118, inhibited the growth of prostate cancer cells in a dose-dependent fashion. In addition, when satraplatin or JM-118 was combined in vitro with Taxotere, a synergistic effect was demonstrated in prostate cancer cells. This synergistic effect was strongest when Taxotere was followed by JM-118.
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. An oral platinum drug could offer key advantages, including ease of administration and patient convenience, in a variety of applications. GPC Biotech believes that satraplatin is also the only platinum compound that has demonstrated activity in a randomized trial in HRPC.
GPC Biotech has completed patient enrollment in a Phase 3 registrational trial – the SPARC trial –which is assessing the safety and efficacy of satraplatin in combination with prednisone as a second-line chemotherapy in patients with HRPC. In December 2005, the Company initiated the rolling submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). Also in December 2005, GPC Biotech signed a co-development and licensing agreement with Pharmion for 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 evaluated the effects of adding satraplatin to radiation therapy, a clinical application in which satraplatin’s oral bioavailability could be particularly advantageous. A Phase 1/2 study evaluating this combination in patients with non-small cell lung cancer has been initiated. Several other Phase 1 and 2 studies evaluating satraplatin in combination with other therapies and in various 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 projections or estimates about plans and objectives relating to our future operations, products, or services; future financial results; or assumptions underlying or relating to any such statements. These statements are forward-looking and are 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 satraplatin will be approved for marketing in a timely manner, if at all. 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
- Laurie Doyle
- Associate Director, Investor Relations & Corporate Communications
- GPC Biotech AG
- Contact via E-mail
This news content was configured by WebWire editorial staff. Linking is permitted.
News Release Distribution and Press Release Distribution Services Provided by WebWire.