-- All pre-specified subset analyses of progression-free survival in the
SPARC Phase 3 trial consistently demonstrate a reduction in relative risk
of disease progression for patients receiving satraplatin. These analyses
included prior Taxotere use, geographies, as well as presence or absence of
pain. -- The two major causes of progression in the SPARC trial -
radiologic progression and pain progression - were each associated with a
36% reduction in relative risk of disease progression.
MARTINSRIED/MUNICH, Germany, June 4 /PRNewswire-FirstCall/ --
Princeton, N.J., and Boulder, CO -- GPC Biotech AG (Frankfurt Stock
Exchange: GPC; TecDAX index)(Nasdaq: GPCB) and Pharmion Corporation
(Nasdaq: PHRM) today announced the presentation of additional data from the
double-blind, randomized satraplatin Phase 3 registrational trial, the
SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The
data are being presented today at the Annual Meeting of the American
Society for Clinical Oncology (ASCO) in Chicago. The SPARC trial is
evaluating satraplatin plus prednisone versus placebo plus prednisone in
950 patients with hormone-refractory prostate cancer (HRPC) whose prior
chemotherapy has failed. A New Drug Application (NDA) for satraplatin is
currently under priority review by the U.S. Food and Drug Administration
(FDA).
"Today hormone-refractory prostate cancer patients whose chemotherapy
has failed have no approved treatment options. The data I have presented
today from the SPARC trial show that satraplatin lowers the risk of disease
progression by 33% compared to control. The data are consistent across
numerous pre-defined subsets, including patients previously treated with
Taxotere," said Cora Sternberg, M.D., FACP, Chief of the Department of
Medical Oncology at the San Camillo and Forlanini Hospitals, Rome, Italy
and one of the principal investigators of the SPARC registrational trial.
"I believe these efficacy results, together with satraplatin's manageable
side effect profile, mean that, if approved, satraplatin will represent an
important new therapy option for patients with advanced prostate cancer
whose prior chemotherapy has failed."
The relative risk of disease progression favored satraplatin for all
pre- specified patient subsets, including prior Taxotere use, geographies,
and the presence or absence of pain. For each of the 20 subsets presented
today, the reduction in relative risk of disease progression ranged from
26% to 46%, corresponding to hazard ratios between 0.74 and 0.54.
Disease progression in the SPARC trial was defined as the first
occurrence of any of several types of progression, including radiologic
tumor progression (RECIST for soft tissue lesions or two or more new
lesions on a bone scan); skeletal-related events (including a bone
fracture, bone surgery or initiation of bisphosphonates); symptomatic
progression (pain, weight loss, worsening of performance status); or death
from any cause. Approximately 37% of patients in the trial progressed by
pain and approximately 36% progressed on radiologic evidence. The hazard
ratio for PFS for the subset of patients with pain progression or death was
0.64 (95% CI: 0.51-0.79, p=0.0001), representing a 36% reduction in the
relative risk of progression. The hazard ratio for PFS for the subset of
patients with radiologic progression or death was 0.64 (95% CI: 0.51-0.81,
p=0.0001), representing a 36% reduction in the relative risk of
progression. The hazard ratio for PFS for the subset of patients who
progressed in ways other than radiologic or pain progression was 0.86 (95%
CI: 0.63-1.17, p > 0.05).
In accordance with the recommendation of the independent Data
Monitoring Board for the SPARC trial, patients who have not progressed
continue to be treated and all patients will be followed for overall
survival. As previously communicated, the interim analysis for overall
survival conducted in June 2006 showed a trend, although not statistically
significant, in favor of the satraplatin arm.
PFS data as observed by the clinical site investigators were also
presented today. Compared to the PFS data previously reported, these
progression events were not adjudicated by the blinded independent review
committee. The hazard ratio for PFS for the intent-to-treat population per
investigator observation was 0.58 (95% CI: 0.50-0.67, p = 0.000000000002).
Median time to progression was 16.0 weeks for the satraplatin arm versus
6.0 weeks for control. The hazard ratio for PFS for the intent-to-treat
population treated with prior Taxotere(R) (docetaxel) per investigator
observation was 0.52 (95% CI: 0.42-0.65, p=0.000000002), with a median time
to progression of 15.3 weeks for the satraplatin arm compared to 5.6 weeks
for control. These data are consistent with the PFS outcomes as adjudicated
by the blinded independent review committee.
Safety findings in the SPARC trial were consistent with previous
clinical studies involving satraplatin. Myelosuppression (decrease in the
production of blood cells by the bone marrow) was the most common adverse
reaction associated with satraplatin therapy. Twenty-one percent of
patients in the satraplatin arm experienced grade 3 or 4 thrombocytopenia;
14% had grade 3 or 4 leucopenia and 21% had grade 3 or 4 neutropenia.
Gastrointestinal disorders were the most frequent non-hematological adverse
events (occurring in 57.9% of the patients receiving satraplatin). Eight
percent of patients in the satraplatin arm experienced grade 3 or 4
gastrointestinal toxicities, including nausea (1.3%), vomiting (1.6%),
diarrhea (2.1%) and constipation (2.1%). Additionally, 5% or less of
patients in the satraplatin arm experienced grade 3 or 4 fatigue (1.7%),
grade 3 or 4 infections (4.0%) and pulmonary/respiratory grade 3 or 4
toxicities (3.0%).
Preliminary data from Phase 2 trial evaluating satraplatin plus Taxol
in non-small cell lung cancer also published in ASCO educational book
Preliminary data from an ongoing Phase 2 trial evaluating satraplatin
plus Taxol(R) (paclitaxel) in the first-line treatment of patients with
advanced non-small cell lung cancer were also published in the ASCO
educational book (Shipley, D. et al. Phase II trial of satraplatin and
paclitaxel in the first-line treatment of advanced non-small cell lung
cancer). Data from 24 patients were available for analysis; a total of
approximately 40 patients are expected to be enrolled in the study. This
preliminary analysis showed that satraplatin plus Taxol appears to have
activity in this treatment setting. In an effort to reduce myelosuppression
in the study, the satraplatin dose has been lowered to 70 mg/m2 from 80
mg/m2. The study continues to enroll and follow patients.
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. Satraplatin is not currently approved by
the FDA in the United States, by the EMEA in the European Union or any
other regulatory authority and no conclusions can or should be drawn
regarding its safety and efficacy.
A Phase 3 registrational trial, called SPARC, is evaluating satraplatin
plus prednisone versus placebo plus prednisone in 950 patients with
hormone- refractory prostate cancer whose prior chemotherapy has failed.
Data from the trial on progression-free survival and on safety have been
presented at recent medical conferences.
GPC Biotech has a co-development and license agreement with Pharmion
GmbH, a wholly owned subsidiary of Pharmion Corporation, under which
Pharmion has been granted exclusive commercialization rights to satraplatin
for Europe and certain other territories. Pharmion has indicated it expects
to complete the Marketing Authorization Application (MAA) for satraplatin
for Europe in the second quarter of 2007. GPC Biotech in-licensed
satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.
Satraplatin has been studied in clinical trials involving a range of
tumors. Trials evaluating the effects of satraplatin in combination with
radiation therapy, in combination with other cancer therapies and in a
number of cancer types are underway or planned.
About Pharmion
Pharmion is a biopharmaceutical 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 drug, Vidaza(R), a DNA
demethylating agent. For additional information about Pharmion, please
visit Pharmion's website at http://www.pharmion.com.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused
on discovering, developing and commercializing new anticancer drugs. GPC
Biotech's lead product candidate satraplatin is currently under review by
the U.S. FDA for hormone-refractory prostate cancer patients whose prior
chemotherapy has failed. 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), and has a wholly owned U.S. subsidiary headquartered in
Princeton, New Jersey. For additional information, please visit GPC
Biotech's Web site at http://www.gpc-biotech.com.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC Biotech AG
and Pharmion Corporation, including statements relating to results of the
SPARC trial and statements relating to the potential efficacy and safety
profile 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
could differ materially depending on a number of factors, and we caution
investors not to place undue reliance on the forward-looking statements
contained in this press release. In particular, there can be no guarantee
that additional information relating to the safety, efficacy or
tolerability of satraplatin may be discovered upon further analysis of data
from the SPARC trial or analysis of additional data from other ongoing
clinical trials for satraplatin. Furthermore, we cannot guarantee that
satraplatin will be approved for marketing in a timely manner, if at all,
by regulatory authorities nor that, if marketed, satraplatin will be a
successful commercial product. We direct you to GPC Biotech's Annual Report
on Form 20-F for the fiscal year ended December 31, 2005, Pharmion's
Quarterly Report on Form 10-Q for the quarterly period ended March 31,
2007, its Annual Report on Form 10-K for the fiscal year ended December 31,
2006, and other reports filed with the U.S. Securities and Exchange
Commission for additional details on the important factors that may affect
the future results, performance and achievements of either Pharmion or GPC
Biotech. Forward-looking statements speak only as of the date on which they
are made and neither Pharmion nor GPC Biotech undertakes any obligation to
update these forward-looking statements, even if new information becomes
available in the future.
Taxotere(R) (docetaxel) is a registered trademark of Aventis Pharma
S.A. Taxol(R) (paclitaxel) is a registered trademark of Bristol-Myers
Squibb Company.
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com
http://www.pharmion.com
CONTACT:
Martin Braendle, Director, Investor Relations
& Corporate Communications, +49 (0)89 8565 2693,
ir@gpc-biotech.com, or in the U.S., Laurie Doyle, Director,
Investor Relations & Corporate Communications, +1-609-524-5884,
usinvestors@gpc-biotech.com, both of GPC Biotech AG; or Breanna
Burkart or Anna Sussman, Directors, Investor Relations and
Corporate Communications of Pharmion Corporation,
+1-720-564-9144, +1-720-564-9143, ir@pharmion.com; or in Europe,
Brian Hudspith of Maitland, +44 (0)20 7379 5151,
bhudspith@maitland.co.uk; or in the U.S., David Schull, Russo
Partners, LLC, +1-212-845-4271,
david.schull@russopartnersllc.com, both for GPC Biotech; or Tara
May, +1-303-646-7832, for Pharmion
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