http://www.arizonabiotech.com/
http://groups.yahoo.com/group/biotech-news/
http://www.arizonaentrepreneurs.com/
http://www.azhttp.com/
| My Groups | biotech-news Main Page | |
GPC Biotech Presents New Satraplatin Pre-clinical Data at AACR
Monday April 3, 4:12 am ET
"The data presented at AACR are supportive of the clinical work we have underway to explore the potential of satraplatin in a variety of combination therapies and cancer settings," said Marcel Rozencweig, M.D., Senior Vice President, Drug Development. "We currently have ongoing two Phase 1 trials evaluating satraplatin in combination with Taxotere in advanced solid tumors. We also have underway a Phase 2 study evaluating satraplatin in metastatic breast cancer, and we expect to further explore satraplatin in this treatment setting in combination with other therapies, such as Herceptin."
A poster entitled, "Synergistic antitumor activity of the combination of satraplatin and docetaxel in H460 human non-small cell lung carcinoma xenografted in nude mice," (Abstract #563) showed results from in vivo studies evaluating the efficacy of satraplatin and Taxotere® (docetaxel), both individually and in combination, using various dosing and treatment schedules. Within the range of doses and schedules tested, a combination of the two compounds administered sequentially results in therapeutically synergistic effects -- i.e., superior to the best result that could be obtained with either agent administered individually -- with no apparent increase in toxicity compared to either single agent in this tumor model. Results evaluating satraplatin and Taxol® (paclitaxel) in this non-small cell lung cancer model were presented in late 2005. The pre-clinical results presented at AACR build on previous data evaluating satraplatin in combination with Taxotere in cells and may be useful in developing appropriate dosing schedules for clinical testing of a combination therapy of satraplatin and Taxotere.
A poster entitled, "Synergistic in vitro anticancer activity of JM118, a metabolite of satraplatin, in combination with Herceptin," (Abstract #1350) evaluated satraplatin's active metabolite, JM118, in combination with Herceptin® (trastuzumab) against SKBR-3 breast cancer cells, which are known to be sensitive to Herceptin. The data showed that, within the range of doses and schedules tested, both concurrent and sequential exposure of the cells to these two compounds resulted in strong synergistic cytotoxic activity. GPC Biotech currently has underway a Phase 2 trial evaluating satraplatin in patients with metastatic breast cancer. The Company is conducting this study to gain more insight into the activity of satraplatin in this important cancer area. The data presented support further exploration of the combination of satraplatin and Herceptin in breast cancer patients.
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. 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 hormone-refractory prostate cancer (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 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 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 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. Forward- looking statements may be, but are not necessarily, identified by words like "believe", "anticipate", "intend", "expect", "target", "goal", "estimate", "plan", "assume", "may", "will", "could" and similar expressions. Forward-looking statements include, but are not limited to, statements about the progress, timing and completion of research, development, pre-clinical studies and clinical trials for the Company's product candidates; the timing and ultimate success in obtaining regulatory approval in the U.S., Europe or any other jurisdiction for satraplatin or any other product candidates; the Company's ability to market, commercialize, achieve market acceptance for and sell the Company's product candidates; the Company's ability to adequately protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; and the Company's estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. There can be no guarantee that the
pre-clinical data discussed in this press release will be useful in determining appropriate dosing and schedules for a combination of satraplatin and Taxotere, nor that satraplatin in combination with Taxotere or with Herceptin will be safe and effective in clinical studies. There can be no guarantee regarding the timing or outcome of ongoing clinical studies with satraplatin. Additionally, there can be no guarantee that satraplatin will be approved for marketing in a timely manner, if at all. Forward-looking statements in this press release are based on the Company's current expectations and projections about future events and are subject to risks, uncertainties and assumptions. In light of these risks, uncertainties and assumptions, the forward-looking events discussed in this press release might not occur. We direct you to the Company's 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 (SEC) for additional details on the important factors that may affect the Company's future results, performance and achievements. Except as required by law, the Company disclaims any intent or obligation to publicly update or revise these forward-looking statements whether as a result of new information, future events or otherwise. You are advised, however, to consult any additional disclosure the Company makes on its current reports on Form 6-K to the SEC.
Herceptin® (trastuzumab) is a registered trademark of Genentech, Inc.
Taxol® (paclitaxel) is a registered trademark of Bristol-Myers Squibb Company.
Taxotere® (docetaxel) is a registered trademark of Aventis Pharma S.A
http://groups.yahoo.com/group/biotech-news/
YAHOO! GROUPS LINKS
- Visit your group "biotech-news" on the web.
- To unsubscribe from this group, send an email to:
[EMAIL PROTECTED]
- Your use of Yahoo! Groups is subject to the Yahoo! Terms of Service.
