MARTINSRIED/MUNICH, Germany and U.S. Research and Development Facilities
in WALTHAM/BOSTON, Mass. and PRINCETON, N.J., July 5 /PRNewswire-FirstCall/ --
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(R) (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 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 --
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
http://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(R) (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
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 Contacts:
In the U.S.:
Euro RSCG Life NRP
Emily Poe
Phone: +1 212 845 4266
emily.poe@eurorscg.com
In Europe:
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 in the U.S.: Laurie Doyle, Associate
Director, Investor Relations & Corporate Communications,
+1-781-890-9007 X267, usinvestors@gpc-biotech.com, both of GPC
Biotech AG; or additional media in the U.S.: Emily Poe of Euro
RSCG Life NRP, +1-212-845-4266, emily.poe@eurorscg.com, or in
Europe, Brian Hudspith of Maitland Noonan Russo, +44 (0)20 7379
5151, bhudspith@maitland.co.uk, both for GPC Biotech AG
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