MARTINSRIED/MUNICH, Germany, Aug. 2 /PRNewswire-FirstCall/ -- WALTHAM,
Mass. and PRINCETON, N.J., -- GPC Biotech AG (Frankfurt Stock Exchange:
GPC; TecDAX index; Nasdaq: GPCB) today announced the initiation of a Phase
2 randomized trial evaluating the Company's lead drug candidate,
satraplatin, in combination with Tarceva(R) (erlotinib) as a first-line
therapy in patients with inoperable advanced non-small cell lung cancer
(NSCLC) who are 70 years of age and older. A Phase 3 registrational trial
exploring satraplatin in combination with prednisone as a second-line
chemotherapy treatment for patients with hormone-refractory prostate cancer
has completed patient enrollment. GPC Biotech continues to open additional
clinical studies to explore the potential of satraplatin in a variety of
tumor types.
The Phase 2 study in advanced NSCLC is a randomized trial that is
expected to involve over 20 centers in the U.S. and Europe and enroll
approximately 120 patients. The primary objective of this study is to
evaluate progression-free survival. The study will also examine overall
survival, response rates and safety.
"Platinum-based combination therapies are often used to treat patients
with advanced non-small cell lung cancer. However, elderly patients are
frequently not treated with standard chemotherapy due to concerns about
their ability to tolerate treatment," said Marcel Rozencweig, M.D., Senior
Vice President, Drug Development and Chief Medical Officer. "A combination
regimen of satraplatin -- an oral, well-tolerated platinum-based compound
-- in combination with another oral, well-tolerated drug such as Tarceva
could, if effective, offer an important new treatment option for this
under-served patient group."
Patients in the Phase 2 trial will be randomized to receive satraplatin
plus Tarceva or Tarceva alone. A sequential dosing regimen will be used in
the satraplatin arm. The treatment cycle for both arms is 28 days. Patients
will be stratified according to smoking history and gender.
About Lung Cancer
Lung cancer is the leading cause of cancer death in the U.S., with an
estimated 162,000 deaths expected from the disease in 2006. Over 170,000
new cases are expected to be diagnosed in 2006. 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% of all lung
cancer cases, and over 50% of patients present with inoperable disease.
Standard first-line chemotherapy for patients with advanced NSCLC
typically involves a combination regimen, frequently with a platinum-based
therapy. For elderly patients or patients with a poor performance status, a
single-agent chemotherapy may be recommended due to concerns about these
patients' ability to tolerate a combination regimen. Thus, there is a need
for well-tolerated, effective combination treatments.
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.
In December 2005, GPC Biotech completed accrual to the SPARC trial that
is evaluating satraplatin in combination with prednisone as second-line
chemotherapy in patients with hormone refractory prostate cancer. Also in
December 2005, GPC Biotech initiated the rolling submission of an NDA for
satraplatin with the FDA. The Company has a co-development and license
agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion
Corporation, under which Pharmion has been 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 hormone-refractory
prostate cancer, ovarian cancer and small cell lung cancer. Other trials
evaluating the effects of satraplatin in combination with radiation
therapy, in combination with other cancer therapies and in various other
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.
About GPC Biotech
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, including,
without limitation, statements about the progress and results of the
outcome of the SPARC trial and other clinical development activities,
regulatory processes and commercialization efforts for satraplatin.
Forward-looking statements are based on the Company's current expectations
and projections about future events and are subject to risks, uncertainties
and assumptions in light of which the forward-looking events discussed in
this press release might not occur. We direct you to the Company's Form
20-F for the fiscal year ended December 31, 2005 and other reports filed
with the U.S. Securities and Exchange Commission for additional details on
the important factors that may affect these statements and the Company's
future results, performance and achievements. Readers are cautioned not to
place undue reliance on these forward-looking statements that speak only as
of the date of this release. Except as required by law, the Company does
not undertake any obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.
Tarceva(R) (erlotinib) is a registered trademark of OSI
Pharmaceuticals, Inc.
For further information, please contact:
GPC Biotech AG
Fraunhoferstr. 20
82152 Martinsried/Munich, Germany
Martin Braendle
Director, 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: +1 781 890 9007 X267
usinvestors@gpc-biotech.com
Additional Media Contacts:
In Europe:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.:
Noonan Russo
Matt Haines
Phone: +1 212 845 4235
matthew.haines@eurorscg.com
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com/
CONTACT:
Martin Braendle, Director, Investor Relations
& Corporate Communications, +49 (0)89 8565-2693,
ir@gpc-biotech.com, or Laurie Doyle, Director, Investor Relations
& Corporate Communications, +1-781-890-9007 ext. 267,
usinvestors@gpc-biotech.com, both of GPC Biotech AG; or In the
U.S.: Matt Haines of Noonan Russo, +1-212-845-4235,
matthew.haines@eurorscg.com; or In Europe: Brian Hudspith of
Maitland Noonan Russo, +44 (0)20 7379 5151,
bhudspith@maitland.co.uk
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