First study by GPC Biotech to evaluate satraplatin in combination with
another oral chemotherapy
MARTINSRIED/MUNICH, Germany, May 16 /PRNewswire-FirstCall/ -- WALTHAM,
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
Xeloda(R) (capecitabine) in patients with advanced solid tumors has opened
for accrual. Xeloda is an oral form of 5-FU, a marketed chemotherapy
treatment that is used to treat various cancers, including metastatic
breast and colorectal cancers.
The Phase 1 study is an open label study being conducted at
Northwestern University Medical Center in Chicago under the direction of
William Gradishar, M.D., Professor of Medicine, Director Breast Medical
Oncology. The primary objective of this study is to determine the maximum
tolerated dose for satraplatin in combination with Xeloda in patients with
advanced solid tumors. The trial is expected to enroll up to 24 patients.
Dr. Gradishar commented: "Combinations of intravenous 5-FU and certain
marketed platinum compounds have shown activity in a number of cancers. I
am excited about the potential that the combination of satraplatin and
Xeloda may hold. This oral-oral regimen, if effective, may offer doctors an
important new, well tolerated and convenient treatment option for patients
with a variety of cancers."
"We are pleased to be working with Dr. Gradishar and his team at
Northwestern. Dr. Gradishar is a distinguished medical oncologist whose
research has been instrumental in developing novel anticancer therapies,"
said Marcel Rozencweig, M.D., Senior Vice President, Drug Development and
Chief Medical Officer of GPC Biotech. "This is the first study we have
opened that is evaluating satraplatin in an oral-oral combination, and
additional such trials are planned. An all-oral regimen holds the
possibility of enabling patients to take their treatments at home instead
of being treated at the hospital."
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 and
initiated the rolling submission of a New Drug Application (NDA) for
satraplatin with the U.S. Food and Drug Administration (FDA). Also in
December 2005, GPC Biotech signed a co-development and license agreement
with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation,
under which Pharmion was 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 HRPC, 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.
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.
Xeloda(R) (capecitabine) is a registered trademark of Hoffmann-La Roche
AG.
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
Matt Haines
Phone: +1 212 845 4235
matthew.haines@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 Laurie Doyle, Associate 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 Euro RSCG Life NRP, +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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