- Full Progression Free Survival Data Expected in Fall 2006 -
MARTINSRIED/MUNICH, Germany, June 8 /PRNewswire-FirstCall/ -- WALTHAM,
Mass., PRINCETON, N.J. and BOULDER, Colo. -- GPC Biotech AG (Frankfurt
Stock Exchange: GPC; TecDAX index; Nasdaq: GPCB) and Pharmion Corporation
(Nasdaq: PHRM) 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 a meeting to review an interim
analysis of overall survival data from the study. The DMB recommended the
trial continue as planned, per protocol.
No safety concerns were raised by the DMB, and they recommended that
the trial continue as planned, without changes. The SPARC trial, therefore,
continues to completion and GPC Biotech and Pharmion remain blinded to the
study data. As previously communicated, the companies expect the full
progression free survival (PFS) data to be available in the fall of this
year. PFS remains the endpoint of the SPARC trial for accelerated approval
in the U.S. and is also the basis, along with supporting overall survival
data, for approval in Europe.
"We look forward to reporting the final PFS results from the trial this
fall. If the data are positive, we anticipate completing the NDA filing by
the end of 2006, and we expect that Pharmion will file its MAA with the
European regulatory authorities in the first quarter of 2007," said Marcel
Rozencweig, M.D., Senior Vice President, Drug Development and Chief Medical
Officer of GPC Biotech. "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 and Pharmion 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 Pharmion 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 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 and 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 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 Pharmion
Pharmion is a biotechnology company focused on acquiring, developing
and commercializing innovative products for the treatment of hematology and
oncology patients in the U.S., Europe and additional international markets.
Pharmion has a number of products on the market including the world's first
approved epigenetic therapy, Vidaza(R), a DNA demethylating agent. For
additional information about Pharmion, please visit the company's website
at http://www.pharmion.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.
For further information, please contact:
For 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
For Pharmion Corporation:
Breanna Burkart/Anna Sussman
Directors, Investor Relations and Corporate Communications
Phone: +1 720 564 9144
ir@pharmion.com
SOURCE GPC Biotech AG
 back to top
Related links:
http://www.gpc-biotech.com
http://www.pharmion.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 Breanna
Burkart or Anna Sussman, Directors, Investor Relations and
Corporate Communications, Pharmion Corporation, +1-720-564-9144,
ir@pharmion.com
|
