Therapeutic synergism in vivo when satraplatin is combined with Taxotere(R)
(docetaxel) in non-small cell lung cancer model
Strong synergistic effect when satraplatin's active metabolite, JM-118, is
combined with Herceptin(R) (trastuzumab) in breast cancer cells
MARTINSRIED/Munich, Germany, April 3 /PRNewswire-FirstCall/ -- WALTHAM,
Mass. and PRINCETON, N.J. -- GPC Biotech AG (Frankfurt Stock Exchange: GPC;
TecDAX index; Nasdaq: GPCB) today announced the presentation of new
pre-clinical data on its lead drug candidate satraplatin at the 97th Annual
Meeting of the American Association for Cancer Research (AACR) in Washington,
DC.
"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(R) (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(R) (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(R) (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(R) (trastuzumab) is a registered trademark of Genentech, Inc.
Taxol(R) (paclitaxel) is a registered trademark of Bristol-Myers Squibb
Company.
Taxotere(R) (docetaxel) is a registered trademark of Aventis Pharma S.A.
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 Contact:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com
CONTACT:
Martin Braendle, Associate Director, Investor
Relations & Corporate Communications, +49 (0)89 8565-2693,
ir@gpc-biotech.com, or Laurie Doyle, Associate Director, Investor
Relations & Corporate Communications, +1-781-890-9007 ext. 267,
usinvestors@gpc-biotech.com, both of GPC Biotech AG; or In
Europe: Brian Hudspith of Maitland Noonan Russo, +44 (0)20 7379
5151, bhudspith@maitland.co.uk
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