GPC Biotech Announces Initiation of NCI-Sponsored Phase 2 Trial of
Satraplatin in Patients with Metastatic Hormone-Refractory Prostate
Cancer Previously Treated with Docetaxel
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Study seeks to determine if presence of certain gene impacts patient
outcome
Martinsried/Munich (Germany) and Princeton, N.J., June 24, 2008 -
GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) today
announced the initiation of a Phase 2 study evaluating satraplatin in
combination with the steroid, prednisone, in patients with metastatic
hormone-refractory prostate cancer (HRPC) who previously have been
treated with docetaxel (Taxotere®). The study is being sponsored by
the U.S. National Cancer Institute (NCI), and the principal
investigator is William L. Dahut, MD, Chief, Genitourinary Research
Section, Medical Oncology Branch, Center for Cancer Research, NCI.
The trial is a single-arm study with a planned enrollment of 66
patients with metastatic HRPC who have been previously treated with
docetaxel therapy and with no more than one other previous cytotoxic
chemotherapy regimen. The primary objective of the trial is to
determine if the presence of certain variants of the gene, ERCC1,
affects progression-free survival in this patient population. ERCC1
is involved in DNA damage repair. Satraplatin, like other platinum
agents, has been shown to work via targeting the DNA in tumor cells.
"The results of this trial may provide important information in
determining which hormone-refractory prostate cancer patients are
more likely to benefit from treatment with satraplatin," said Martine
George, MD, Senior Vice President, Drug Development and Chief Medical
Officer at GPC Biotech. "We are pleased to be working with the NCI
to conduct this potentially ground-breaking study."
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum
family of compounds. Platinum-based drugs are a critical part of
modern chemotherapy treatments and are used to treat a wide variety
of cancers. All platinum drugs currently on the market require
intravenous administration. Satraplatin is an oral compound that
clinical trial patients are able to take at home. A Marketing
Authorization Application for satraplatin in combination with
prednisone is currently under review in Europe for the treatment of
hormone-refractory prostate cancer patients whose prior chemotherapy
has failed. A decision on the filing by the European regulators is
expected in the second half of 2008.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused
on anticancer drugs. GPC Biotech's lead product candidate is
satraplatin, an oral platinum compound. The Company has various
anti-cancer programs in research and development that leverage its
expertise in kinase inhibitors. GPC Biotech AG is headquartered in
Martinsried/Munich (Germany) and has a wholly owned U.S. subsidiary
in Princeton, New Jersey. For additional information, please visit
GPC Biotech's Web site at www.gpc-biotech.com.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC
Biotech, including statements about the efficacy and safety of
satraplatin. Such statements are based on current expectations and
are subject to risks and uncertainties, many of which are beyond our
control, that could cause future results, performance or achievements
to differ significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Actual
results could differ materially depending on a number of factors, and
we caution investors not to place undue reliance on the
forward-looking statements contained in this press release.
Satraplatin may not be approved for marketing in a timely manner, if
at all. We direct you to GPC Biotech's Annual Report on Form 20-F
for the fiscal year ended December 31, 2006 and other reports filed
with the U.S. Securities and Exchange Commission for additional
details on the important factors that may affect the future results,
performance and achievements of GPC Biotech. Forward-looking
statements speak only as of the date on which they are made and GPC
Biotech undertakes no obligation to update these forward-looking
statements, even if new information becomes available in the future.
Satraplatin has not been approved by the FDA in the U.S., the EMEA in
Europe or any other regulatory authority and no conclusions can or
should be drawn regarding its safety or effectiveness. Only the
relevant regulatory authorities can determine whether satraplatin is
safe and effective for the use(s) being investigated.
Taxotere® is a registered trademark of Aventis Pharma S.A.
For further information, please contact:
GPC Biotech AG
Investor Relations & Corporate Communications
Phone: +49 (0)89 8565-2693
ir@gpc-biotech.com
In the U.S.: Laurie Doyle
Director, Investor Relations & Corporate Communications
Phone: +1 609-524-5884
usinvestors@gpc-biotech.com
Additional media contacts for Europe:
MC Services AG
Phone: +49 (0) 89 210 228 0
Raimund Gabriel
raimund.gabriel@mc-services.eu
Stefan Riedel
stefan.riedel@mc-services.eu
Additional investor contact for Europe:
Trout International LLC
Lauren Rigg, Vice President
Phone: +44 207 936 9325
lrigg@troutgroup.com
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GPC Biotech AG
Fraunhoferstr. 20 Martinsried
WKN: 585150; ISIN:
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