Pharmion and GPC Biotech Announce Results of Overall Survival Analysis From the Satraplatin Pivotal Phase 3 Trial
31 Outubro 2007 - 1:27AM
PR Newswire (US)
- Overall survival results do not achieve statistical significance
BOULDER, Colo., MARTINSRIED, Germany, MUNICH, Germany and
PRINCETON, N.J., Oct. 30 /PRNewswire-FirstCall/ -- Pharmion
Corporation (NASDAQ:PHRM) and GPC Biotech AG (Frankfurt Stock
Exchange: GPC; TecDAX index; Nasdaq: GPCB) today announced topline
overall survival results for the double-blinded, randomized
satraplatin Phase 3 registrational trial, the SPARC trial
(Satraplatin and Prednisone Against Refractory Cancer). The trial
evaluated satraplatin plus prednisone versus placebo plus
prednisone as a second-line treatment in 950 patients with
hormone-refractory prostate cancer (HRPC). The companies reported
that the trial did not achieve the endpoint of overall survival
(p=0.80, stratified log rank analysis). The median was 61.3 weeks
for the satraplatin arm compared to 61.4 weeks for the control
group and the hazard ratio was 0.97 (95% CI: 0.83, 1.13). The
companies are currently conducting pre-specified subset analyses.
Based on the results announced today, GPC Biotech is re-evaluating
its development plans for satraplatin, including SPERA, the
Satraplatin Expanded Rapid Access protocol in the U.S. "We are
extremely disappointed with the findings we announced today," said
Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC
Biotech. "We are currently discussing with our partners, Pharmion
and Yakult, plans for the future development of satraplatin. I
would like to warmly thank and recognize the contributions of the
investigators and patients, as well as their families, who
participated in the SPARC trial." "These results are clearly
disappointing and will impact the EMEA review of our current
Marketing Authorization Application for satraplatin," said Patrick
J. Mahaffy, President and Chief Executive Officer of Pharmion
Corporation. "The key for our European submission now will be to
conduct the pre-specified subset analyses and particularly to focus
on the impact of prior Taxotere(R) use, which we know is very
important to the EMEA." Pharmion's Marketing Authorization
Application with the European Medicines Agency (EMEA) for
satraplatin in combination with prednisone for the treatment of
patients with metastatic HRPC who have failed prior chemotherapy
was submitted in June 2007. The submission, based on the
statistically significant progression-free survival results
announced in September 2006, was timed so that overall survival
data could be submitted during the review process. Pharmion plans
to review the additional analyses and work closely with the EMEA to
determine next steps for the filing. Conference Calls Scheduled GPC
Biotech will hold a conference call on Wednesday, October 31, 2007
at 13:30 CET/8:30 AM ET. Pharmion Corporation will hold its
previously announced conference call to discuss third quarter
results on October 31st at 5:00 PM ET. Participants may listen via
live webcast, accessible through each company's Web site at
http://www.pharmion.com/, http://www.gpc-biotech.com/, or via
telephone. Dial-in numbers for the GPC Biotech conference call are
as follows: Europe: 0049-(0)89-9982-99911 or 0044-(0)20-7806-1957
U.S.: 1-718-354-1389 About Pharmion Pharmion is a leading global
oncology 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 the company'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 is satraplatin, an oral platinum compound.
The Company has various anti-cancer programs in research and
development 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 summary statements relating to top line
results of the SPARC trial and summary 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. We
direct you to GPC Biotech's Annual Report on Form 20-F for the
fiscal year ended December 31, 2006, 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. DATASOURCE: Pharmion Corporation
CONTACT: Breanna Burkart or Anna Sussman, Directors, Investor
Relations and Corporate Communications, both of Pharmion
Corporation, +1-720-564-9150, ; or Martin Braendle, Director,
Investor Relations & Corporate Communications of GPC Biotech
AG, +49 (0)89 8565 2693, ; or Laurie Doyle, Director, Investor
Relations & Corporate Communications, +1-609-524-5884, ; or
Tara May of Ogilvy Public Relations, +1-303-646-7832, for Pharmion
Corporation; or Brian Hudspith, +44 (0)20 7379 5151, , for GPC
Biotech; or David Schull of Russo Partners, LLC, +1-212-845-4271, ,
for GPC Biotech Web site: http://www.pharmion.com/
http://www.gpc-biotech.com/
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