MARTINSRIED/MUNICH, Germany, April 19 /PRNewswire-FirstCall/ -- U.S.
Research and Development Facilities in Waltham/Boston, 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 SPARC registrational trial in second-line hormone
refractory prostate cancer held a meeting on April 18, 2005 to review safety
data from the ongoing study. The DMB reviewed the safety data from the first
262 patients who were 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 remain sound and recommended that the trial
continue as planned.
As previously reported, GPC Biotech remains on schedule to complete
patient enrollment in the SPARC trial by the end of 2005 and to complete the
NDA (New Drug Application) filing with the U.S. FDA in the second half of
2006.
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. Additionally, satraplatin is the
only platinum-based compound to have shown efficacy in a randomized clinical
trial in prostate cancer. Prostate cancer is the most common cancer among men
in the U.S. and Europe. The number of patients with this disease is expected
to increase with the aging population. As the disease advances, patients are
often treated with hormone therapy. Once patients fail hormone therapy,
becoming hormone-refractory, follow-on treatment involves a limited number of
options, including chemotherapy. For patients who then fail first-line
chemotherapy, there are currently no approved second-line chemotherapy
regimens. Satraplatin is in a Phase 3 registrational trial -- the SPARC trial
-- as a second-line chemotherapy treatment for HRPC. GPC Biotech has
successfully 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.
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. Additional studies evaluating satraplatin in combination with
other therapies in various cancers are planned. Further 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 --
is currently in a Phase 3 registrational trial as a second-line chemotherapy
treatment in hormone-refractory prostate cancer following successful
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. Satraplatin was in-licensed from Spectrum Pharmaceuticals, Inc.
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
inhibitor, currently in pre-clinical development. The Company is leveraging
its drug discovery technologies to elucidate the mechanisms-of-action of drug
candidates and to support the growth of its drug pipeline. GPC Biotech also
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
http://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. We direct you to the
Company's Annual Report on Form 20-F 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.
For further information, please contact:
GPC Biotech AG Fraunhoferstr.
20 82152 Martinsried/Munich, Germany
Phone/Fax: +49 (0)89 8565-2600/-2610
info@gpc-biotech.com
Martin Braendle (ext. 2693) Senior Manager, Investor Relations &
Corporate Communications
martin.braendle@gpc-biotech.com
In the U.S.:
Laurie Doyle
Associate Director, Investor Relations &
Corporate Communications
Phone: +1 781 890 9007 X267
laurie.doyle@gpc-biotech.com
Additional Media Contacts:
Euro RSCG Life NRP
In NY: Mark Vincent
Vice President
Phone: +1 212 845 4239
mark.vincent@eurorscg.com
In Europe
Maitland Noonan Russo
In London: 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, Senior Manager, Investor
Relations & Corporate Communications, +49 (0)89 8565-2600 ext.
2693, martin.braendle@gpc-biotech.com, or In the U.S.: Laurie
Doyle, Associate Director, Investor Relations & Corporate
Communications, +1-781-890-9007 ext. 267,
laurie.doyle@gpc-biotech.com, both of GPC Biotech AG; or in NY:
Mark Vincent, Vice President of Euro RSCG Life NRP,
+1-212-845-4239, mark.vincent@eurorscg.com; or in London: Brian
Hudspith of Maitland Noonan Russo, +44 (0)20 7379 5151,
bhudspith@maitland.co.uk
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