-- Median time to pain progression is 66.1 weeks for the satraplatin arm
compared with 22.3 weeks for the placebo arm -- Hazard ratio of 0.64 (95%
CI: 0.51-0.79, p<0.001), representing a 36% reduction in the relative risk
of pain progression
MARTINSRIED/MUNICH, Germany, May 21 /PRNewswire-FirstCall/ --
PRINCETON, N.J., and BOULDER, Colo. -- 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
Urological Association (AUA) in Anaheim, California. 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. An NDA for satraplatin is currently under priority
review by the U.S. FDA.
"Patients with metastatic hormone-refractory prostate cancer frequently
suffer from substantial pain associated with bone metastases. Thus, pain
control for these patients constitutes a major challenge and is an
important goal when caring for them," said Oliver Sartor, M.D., Lank Center
for Genitourinary Oncology, Dana Farber Cancer Institute, Associate
Professor at Harvard Medical School, Boston, MA, and principal investigator
of the SPARC trial, who is presenting the satraplatin data today. "In
addition to the very encouraging results for progression-free survival
demonstrating a 33% lower risk of progression compared to control, it is
exciting to see that the SPARC trial results show that treatment with
satraplatin also results in a statistically significant improvement in time
to pain progression."
Data presented today showed that the median time to pain progression
was 66.1 weeks for the satraplatin arm compared with 22.3 weeks for the
placebo arm. The hazard ratio was 0.64 (95% CI: 0.51-0.79, p<0.001), which
translates into a 36% reduction in the relative risk of pain progression.
These results were consistent across multiple pre-defined subsets of
patients, including patients treated with prior Taxotere(R) (docetaxel).
All pain progression events were assigned by a blinded independent review
committee. Complementing the time to pain progression data, pain response
rates were 24.2 percent for the satraplatin plus prednisone arm (N=351)
compared with 13.8 percent for the placebo arm (N=181) (p=0.005). Pain
response rates for patients treated with prior Taxotere were 25.7 percent
for the satraplatin arm compared with 13.1 percent for control (p<0.015).
All of the findings presented today continue to build on the data
previously presented from the SPARC trial.
Pain response was assessed by patients using a weekly present pain
intensity (PPI) and analgesic score. The PPI score was defined according to
the McGill-Melzack questionnaire with 0 = no pain, 1 = mild pain, 2 =
discomforting pain, 3 = distressing pain, 4 = horrible pain and 5 =
excruciating pain. The criteria for pain response are a greater than or
equal to 2 point reduction in the patients' weekly PPI score from baseline
and maintenance of the two point reduction for at least five consecutive
weeks in the setting of a stable or decreasing weekly analgesic score
compared to baseline. Patients were evaluable for pain response if their
baseline PPI score was greater than or equal to one and had completed four
consecutive weekly assessments of PPI and analgesic scores during the study
treatment.
Safety findings in the SPARC trial were consistent with previous
clinical studies involving satraplatin. The most common adverse reactions
consisted of myelosuppression (bone marrow functions): Twenty-one percent
of patients in the satraplatin arm experienced grade 3 or 4
thrombocytopenia; 14 percent had leucopenia and 21 percent had neutropenia.
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%). Five percent or less of patients
in the satraplatin arm experienced grade 3 or 4 fatigue, grade 3 or 4
infections and pulmonary/respiratory grade 3 or 4 toxicities.
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 orally bioavailable compound and is given
as capsules that patients can take at home.
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. 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.
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 cancer 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 about the status of the FDA
review process. 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 Annual Report
on Form 10-K for the fiscal year ended December 31, 2006, its most recent
filings on Form 10-Q 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.
Satraplatin has not yet 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.
Taxotere(R) (docetaxel) is a registered trademark of Aventis Pharma
S.A.
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com
http://www.pharmion.com
CONTACT:
GPC Biotech AG - 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; Pharmion Corporation - Breanna
Burkart/Anna Sussman, Directors, Investor Relations and Corporate
Communications, +1-720-564-9150, ir@pharmion.com; Additional
Media Contacts for GPC Biotech - In Europe: Brian Hudspith of
Maitland, +44 (0)20 7379 5151, bhudspith@maitland.co.uk, or in
the U.S.: David Schull of Russo Partners, LLC, +1-212-845-4271,
david.schull@russopartnersllc.com
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