New Data from Satraplatin Phase 3 Trial in Second-Line
Castrate-Refractory Prostate Cancer Presented at 2009 ASCO Annual
Meeting
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* SPARC trial analyses demonstrate pain at baseline, pain
progression and progression-free survival at three months are
predictive of overall survival in metastatic castrate-refractory
prostate cancer patients previously treated with docetaxel
* Data from several other trials evaluating satraplatin in
combination with various anti-cancer therapies published in ASCO
Proceedings
Martinsried/Munich (Germany) and Princeton, N.J., June 2, 2009 - GPC
Biotech AG (Frankfurt Stock Exchange: GPC) today announced that data
from the double-blind, randomized satraplatin Phase 3 trial, the
SPARC trial (Satraplatin and Prednisone Against Refractory Cancer),
were presented at the 2009 American Society for Clinical Oncology
(ASCO) Annual Meeting in Orlando, Florida. The SPARC trial evaluated
satraplatin plus prednisone versus placebo plus prednisone in 950
patients with castrate-refractory prostate cancer (CRPC) who had
progressed after initial chemotherapy. The data presented are
retrospective analyses of the SPARC trial evaluating correlations
between overall survival (OS) and pain at baseline, pain progression,
and progression-free survival (PFS) at three months.
One presentation ("Use of pain at baseline and pain progression to
predict overall survival in patients with docetaxel pretreated
metastatic castration-refractory prostate cancer: results from the
SPARC trial," Sartor et al, Abstract #5148), analyzed the
docetaxel-pretreated population (n= 488) in two separate ways:
* The first analysis compared OS in those patients who had no pain
(Present Pain Intensity (PPI) score < or =1) vs. those with pain
(PPI > or =2) at time of entry to the trial.
* The second analysis compared OS in those patients who experienced
pain progression versus progression by pre-specified measures
other than pain (as judged by the blinded Independent Review
Committee (IRC)).
Shorter OS time was observed in docetaxel-pretreated patients who had
pain at baseline compared to those who did not. The median survival
of patients with baseline pain (n=178) was 44 weeks versus 72 weeks
for patients without baseline pain (n=287) [stratified hazard ratio:
0.59 (95% CI: 0.48-0.74), stratified log-rank p<0.0001]. The IRC
found that 414 docetaxel-pretreated patients (84.8%) progressed as of
the data cutoff date for the SPARC study. Of these, the median
survival of patients showing pain progression (n=196) was 47 weeks,
compared to 71 weeks for non-pain progressors (n=292) [stratified
hazard ratio: 0.71 (95% CI: 0.57-0.87), stratified log-rank
p=0.0022]. Thus, pain at baseline, as well as pain progression, were
prognostic indicators of OS in the docetaxel-pretreated patient
population.
A second presentation ("Correlation of progression-free survival and
overall survival in men with metastatic castration-resistant prostate
cancer who failed first-line chemotherapy: results from the SPARC
trial," Halabi et al, Abstract #5150) evaluated whether PFS at three
months was predictive of OS and explored the statistical dependencies
between PFS and OS. Of the 853 men alive at three months
post-randomization, 477 (56%) had already progressed. The median
survival for this group was 34.5 weeks versus 78.7 weeks in men who
had not progressed at the same three months timepoint. [hazard ratio:
2.16 (95% CI =1.84-2.55), p-value <0.001]. The dependence between PFS
and OS was 0.29 (95% confidence limits = 0.24-0.33, p-value <
0.00001). Thus PFS at three months was predictive of OS. Additional
studies will be needed to assess the clinical relevance of the
individual components of progression as defined in the SPARC trial to
OS.
Data from other Phase I and Phase II clinical trials evaluating
satraplatin in combination with other cancer therapeutic drugs were
published in the 2009 ASCO Annual Meeting Proceedings:
- Phase II trial of bevacizumab and oral satraplatin and prednisone
in docetaxel pretreated metastatic castrate resistant prostate cancer
- Vaishampayan et al (Abstract #e16028).
- Dose finding study of the combination of satraplatin and
gemcitabine in patients with advanced solid tumors - Di Paola et al
(Abstract #e13534).
- A phase I study investigating the combination of orally
bioavailable platinum and nonparticle albumin-bound paclitaxel in
advanced solid tumors - Deshpande et al (Abstract #e13501).
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum
family of compounds. Platinum-based drugs are a critical part of
modern chemotherapy treatments and are used to treat a wide variety
of cancers. All platinum drugs currently on the market require
intravenous administration. Satraplatin is an oral compound that
clinical trial patients are able to take at home. GPC Biotech has a
license agreement with Yakult Honsha Co. Ltd. under which Yakult has
exclusive commercialization rights to satraplatin for Japan. GPC
Biotech is currently in discussions with Yakult regarding further
development and registrational efforts for satraplatin. GPC Biotech
in-licensed satraplatin from Spectrum Pharmaceuticals, Inc.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused
on developing anti-cancer drugs. The Company currently has two
programs in clinical development: satraplatin, an oral platinum
compound and RGB-286638, a multi-targeted protein kinase inhibitor.
On February 18, 2009 the Company announced plans to combine its
business with Agennix, Incorporated, a privately-held biotechnology
company located in Houston, Texas. Agennix is developing oral
talactoferrin, a product candidate that is currently in Phase 3
trials for non-small cell lung cancer. GPC Biotech AG is
headquartered in Martinsried/Munich (Germany) and has a wholly owned
U.S. subsidiary in Princeton, New Jersey. For additional information,
please visit GPC Biotech's Web site at www.gpc-biotech.com.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC
Biotech, including statements about the efficacy and safety of
satraplatin. Such statements are based on current expectations and
are subject to risks and uncertainties, many of which are beyond our
control, that could cause future results, performance or achievements
to differ significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Actual
results of future clinical trials of satraplatin could differ
materially from the findings of the retrospective data analyses
presented in this press release, and we caution investors not to
place undue reliance on the forward-looking statements contained in
this press release. Satraplatin may not be approved for marketing in
a timely manner, if at all. Forward-looking statements speak only as
of the date on which they are made and GPC Biotech undertakes no
obligation to update these forward-looking statements, even if new
information becomes available in the future.
Satraplatin has not been approved by the FDA in the U.S., the EMEA in
Europe or any other regulatory authority and no conclusions can or
should be drawn regarding its safety or effectiveness. Only the
relevant regulatory authorities can determine whether satraplatin is
safe and effective for the use(s) being investigated.
For further information, please contact:
GPC Biotech AG
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: +1 609-524-5884
usinvestors@gpc-biotech.com
Additional media contacts for Europe:
MC Services AG
Phone: +49 (0) 89 210 228 0
Raimund Gabriel
raimund.gabriel@mc-services.eu
Hilda Juhasz
hilda.juhasz@mc-services.eu
Additional investor contact for Europe:
Trout International LLC
Lauren Rigg, Vice President
Phone: +44 207 936 9325
lrigg@troutgroup.com
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