* Data Monitoring Board Reports Design and Conduct of Trial Remain Sound
* SPARC Trial Passes Futility Analysis
* Full Progression Free Survival Data Expected in Fall 2006
MARTINSRIED/MUNICH (Germany) April 25 /PRNewswire-FirstCall/ --
WALTHAM, Mass. and PRINCETON, N.J. -- GPC Biotech AG (Frankfurt Stock
Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced that the
independent Data Monitoring Board (DMB) for the satraplatin Phase 3
registrational trial SPARC (Satraplatin and Prednisone Against Refractory
Cancer) in second-line chemotherapy for hormone-refractory prostate cancer
has held its planned meeting to review interim safety and efficacy data
from the study. As expected, the DMB recommended that the trial should
continue to completion.
The DMB analyzed the efficacy data as assessed by the blinded
independent progression review panel on the first 354 progression-free
survival (PFS) events and also reviewed the safety data from the first 593
patients who had been randomized in the trial and had completed at least
one cycle of treatment. After reviewing the data, the DMB reported that the
design and conduct of the trial remained sound. In addition, the DMB
determined that the SPARC trial had also passed the pre-defined futility
analysis. The SPARC trial, therefore, continues to completion and GPC
Biotech remains blinded to the study data.
"We are delighted that the independent Data Monitoring Board made this
recommendation and that satraplatin passed the futility analysis," said
Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. "The results of
this planned interim analysis are as expected -- namely that the Board has
recommended that the SPARC trial continue to its completion. We look
forward to reporting the final PFS results from the trial this fall and, if
the data are positive, we anticipate completing the NDA filing by the end
of 2006. In parallel to completing the registrational trial, we will
continue to initiate additional clinical trials with satraplatin in other
cancer indications and in combination with other anticancer treatments."
About the Data Monitoring Board
The Data Monitoring Board consists of independent oncology and
statistical experts whose primary responsibility is to monitor, on a
periodic basis, the data from the SPARC trial and to provide
recommendations to GPC Biotech on whether the study should proceed as
originally planned, be modified or be discontinued. Members of the Data
Monitoring Board are independent from GPC Biotech and also do not
participate as clinical investigators in the SPARC trial.
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.
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.:
Noonan Russo
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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