GPC Biotech Announces Phase 1 Trial Evaluating Satraplatin in
Combination with TAXOTERE(R) in Patients with Advanced Solid Tumors
Opens for Accrual
MARTINSRIED/MUNICH, Germany and U.S. Research and Development
Facilities in WALTHAM/BOSTON, Mass. and PRINCETON, N.J.,
-- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX index;
Nasdaq: GPCB) today announced that a Phase 1 study evaluating the
Company's lead drug candidate, satraplatin, in combination with
TAXOTERE® (docetaxel) in patients with advanced solid tumors has
opened for accrual. Satraplatin is currently in a Phase 3
registrational trial as a second-line chemotherapy treatment for
patients with hormone-refractory prostate cancer.
The Phase 1 study is an open label, single center study being led by
Lynn Van Ummersen, M.D. Assistant Professor and George Wilding,
M.D., Professor at the University of Wisconsin Comprehensive Cancer
Center (UWCCC), Madison, Wisconsin. The primary objectives of this
study are to assess toxicity, determine maximum tolerated doses, and
recommend Phase II dosage for this combination. The objective
response in those patients with measurable disease will also be
assessed. The study is expected to enroll up to 48 patients.
"I am excited to have the opportunity for the UWCCC to conduct this
clinical study to develop a treatment regimen combining satraplatin
and TAXOTERE," said Dr. Wilding. "The favorable safety profile and
clinical activity of satraplatin in several solid tumor types and
the proven efficacy of TAXOTERE in various cancers make this a
treatment regimen that has the potential to help many patients with
cancer."
"We are pleased to have Dr. Van Ummersen and Dr. Wilding run this
trial. They have extensive experience in conducting Phase 1 cancer
studies and the UWCCC is a leader in the oncology field," said
Marcel Rozencweig, M.D., Senior Vice President, Drug Development at
GPC Biotech. "This study is part of our strategy to initiate a
number of studies to explore the potential of satraplatin in
combination with other anticancer therapies and for the treatment of
other cancers beyond the initial indication of second-line hormone-
refractory prostate cancer."
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. Worldwide sales of
these drugs exceeded $2.2 billion in 2004. 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. Additionally, satraplatin is the only platinum-based
compound to have shown efficacy in a randomized clinical trial in
prostate cancer. Prostate cancer is the most common cancer among men
in the U.S. and Europe. The number of patients with this disease is
expected to increase with the aging population. As the disease
advances, patients are often treated with hormone therapy. Once
patients fail hormone therapy, becoming hormone-refractory, follow-
on treatment involves a limited number of options, including
chemotherapy. For patients who then fail first-line chemotherapy,
there are currently no approved second-line chemotherapy regimens.
Satraplatin is in a Phase 3 registrational trial -- the SPARC trial -
- as a second-line chemotherapy treatment for hormone-refractory
prostate cancer (HRPC). GPC Biotech has successfully completed a
Special Protocol Assessment with the U.S. FDA and has received a
Scientific Advice letter from the European regulatory authority, the
European Medicines Agency (EMEA). The FDA has also granted fast
track designation to satraplatin for this indication.
Phase 2 trials have been completed in HRPC, ovarian cancer and small-
cell lung cancer. Promising early clinical results have also been
shown when satraplatin is combined with radiation therapy, and a
Phase 1/2 study evaluating this combination in patients with non-
small cell lung cancer has been initiated. Additional studies
evaluating satraplatin in combination with other therapies in
various cancers are planned. Further 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 -- is currently in a Phase 3 registrational
trial as a second-line chemotherapy treatment in hormone-refractory
prostate cancer following successful completion of a Special
Protocol Assessment by the U.S. FDA and receipt of a Scientific
Advice letter from the European central regulatory authority, EMEA.
The FDA has also granted fast track designation to satraplatin for
this indication. Satraplatin was in-licensed from Spectrum
Pharmaceuticals, Inc. Other anticancer programs include: a
monoclonal antibody with a novel mechanism-of-action against a
variety of lymphoid tumors, currently in Phase 1 clinical
development, and a small molecule broad-spectrum cell cycle
inhibitor, currently in pre-clinical development. The Company is
leveraging its drug discovery technologies to elucidate the
mechanisms-of-action of drug candidates and to support the growth of
its drug pipeline. GPC Biotech also has a multi-year alliance with
ALTANA Pharma AG working with the ALTANA Research Institute in the
U.S., which provides GPC Biotech with revenues through mid-2007. GPC
Biotech AG is headquartered in Martinsried/Munich (Germany). The
Company's wholly owned U.S. subsidiary has research and development
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 relating to
plans and objectives relating to our future operations, products, or
services; future financial results; or assumptions underlying or
relating to any such statements; each of which constitutes a forward-
looking statement 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 the SPARC trial will be completed nor that
satraplatin will be approved for marketing in a timely manner, if at
all. In addition, there can be no guarantee regarding the results of
the satraplatin and TAXOTERE Phase I study. 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.
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
[EMAIL PROTECTED]
In the U.S.: Laurie Doyle
Associate Director, Investor Relations & Corporate
Communications
Phone: +1 781 890 9007 X267
[EMAIL PROTECTED]
Additional Media Contacts:
In the U.S.:
Euro RSCG Life NRP
Emily Poe
Phone: +1 212 845 4266
[EMAIL PROTECTED]
In Europe:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
[EMAIL PROTECTED]
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Source: GPC Biotech AG
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