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[ biotech news ] GPC Biotech Announces Start of Phase 2 Trial Evaluating Satraplatin Plus Taxol(R
GPC Biotech Announces Start of Phase 2 Trial Evaluating Satraplatin
Plus Taxol(R) in Patients With Advanced Non-Small Cell Lung Cancer
http://www.arizonabiotech.com/
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MARTINSRIED/MUNICH, GERMANY -- 12/09/2005 -- Waltham, Mass. and
Princeton, N.J. -- GPC Biotech AG (Frankfurt: GPC) (TecDAX Index)
(NASDAQ: GPCB) today announced that a Phase 2 study evaluating the
Company's lead drug candidate, satraplatin, in combination with
Taxol® (paclitaxel) as a first-line therapy in patients with
unresectable advanced non-small cell lung cancer (NSCLC) 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 Company is also opening new
clinical studies to explore the potential of satraplatin in a number
of additional tumor types.
The Phase 2 study in advanced NSCLC is an open label study being led
by investigators at the Sarah Cannon Research Institute (SCRI) in
Nashville, Tennessee. The study will also be open for accrual in
their affiliated network of oncologists, Tennessee Oncology. The
primary objective of this study is to determine the objective
response rate of satraplatin in combination with Taxol in this
patient population. The study will also examine time to progression
and overall survival. The study is expected to enroll up to 40
patients.
"I look forward to further exploring the potential of satraplatin
with Taxol in the advanced lung cancer setting, as this new study
builds on the Phase 1 study my team did with this combination," said
F. Anthony Greco, M.D., Medical Director, SCRI. "Platinum-based
therapies are widely used to treat patients with advanced non-small
cell lung cancer. Satraplatin, as an oral platinum-based compound
that is well tolerated, could, if effective, be an important new
option for treating patients with this disease."
"SCRI is a renowned research support services organization that
works in concert with the Sarah Cannon Cancer Center, the largest,
privately-funded, community-based cancer treatment program in the
U.S. Dr. Greco is a distinguished medical oncologist there who has
been instrumental in developing new and improved therapies for
cancer," said Marcel Rozencweig, M.D., Senior Vice President, Drug
Development of GPC Biotech. "The opening of this trial continues our
strategy of initiating studies at highly regarded cancer centers to
explore the potential of satraplatin in combination with other
anticancer therapies and for the treatment of other cancers beyond
the initial indication for second-line chemotherapy of hormone-
refractory prostate cancer."
Lung cancer is the leading cause of cancer death in the U.S., with
an estimated 163,000 deaths expected from the disease in 2005. Over
170,000 new cases are expected to be diagnosed in 2005. The five-
year survival rate for lung cancer in the U.S. is only 15 percent.
Recent statistics for Europe estimated over 375,000 cases annually
of lung cancer and over 345,000 deaths from the disease. NSCLC
accounts for over 80 percent of all lung cancer cases.
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. 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 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. Satraplatin
was in-licensed from Spectrum Pharmaceuticals, Inc.
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. Several others studies
evaluating satraplatin in combination with other therapies and in
various cancers are underway or planned. Further information on
satraplatin can be found in the Anticancer Programs section of the
Company's Web site at www.gpc-biotech.com.
About Sarah Cannon Research Institute
Sarah Cannon Research Institute (SCRI), a company created by HCA and
Tennessee Oncology, is dedicated to advancing solutions for a
healthier tomorrow through clinical research. It is one of the
largest, community-based research support programs offering
management, regulatory and other research support services for
strategic investigator sites across the country in ten therapeutic
areas. SCRI works to provide greater access to oncology-related
clinical trials in a community setting through a powerful network of
500 oncologists in 25 states.
About GPC Biotech
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 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. 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 inhibitors program,
currently in pre-clinical development. The Company also has a number
of drug discovery programs that leverage its expertise in kinase
inhibitors. GPC Biotech 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 Phase 2 study in combination with paclitaxel in
patients with advanced non-small cell lung cancer. 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.
Taxol® (paclitaxel) is a registered trademark of Bristol-Myers
Squibb Company.
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