MARTINSRIED/MUNICH, GERMANY and PRINCETON, NJ--(Marketwire - June 02, 2009) - GPC Biotech
AG (FRANKFURT: GPC) (XETRA: 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 less than or equal to 1) vs. those with
pain (PPI greater than or equal to 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 less than 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 less than
0.001]. The dependence between PFS and OS was 0.29 (95% confidence
limits=0.24-0.33, p-value less than 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).
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.