MARTINSRIED/MUNICH, Germany, WALTHAM, Mass. and PRINCETON, N.J., Feb.
21 /PRNewswire-FirstCall/ -- GPC Biotech AG (Frankfurt Stock Exchange: GPC;
TecDAX index; Nasdaq: GPCB) today announced that the Company has launched
the Satraplatin Expanded Rapid Access protocol (SPERA) in the U.S. Expanded
Access Programs (EAPs) are intended to give patients access to
investigational drugs to treat serious or life-threatening diseases or
conditions for which there are no adequate therapies available. Under the
SPERA program, satraplatin will be provided to patients free of charge.
"There is an important medical need for treatments for
hormone-refractory prostate cancer patients whose first-line chemotherapy
has failed," said Martine George, M.D., Senior Vice President, Clinical
Development, GPC Biotech. "We look forward to working with clinicians to
make satraplatin available through the SPERA program to these patients who
currently have no approved treatment options for their disease."
U.S. physicians interested in receiving more information about SPERA
can contact 1-800-349-8086 or http://www.speratrial.com.
About Prostate Cancer
Prostate cancer is the most common cancer among men in the U.S. and
Europe. Approximately 219,000 men in the U.S. are expected to be diagnosed
with the disease in 2007, and over 27,000 men are expected to die from the
disease. In the European Union, over 200,000 new cases are expected to be
diagnosed, and over 60,000 patients are expected to die each year. Since
the incidence of prostate cancer increases with age, the aging of the
overall population is expected to further increase the number of prostate
cancer patients.
Most patients diagnosed with prostate cancer initially receive surgery
or radiation therapy, and some of these patients are cured. For many
others, though, the disease recurs. At this point, the recurrent disease is
treated with hormone therapy, and most patients initially respond well to
this treatment. Eventually, however, the tumor cells become resistant to
the hormones - or "hormone-refractory" - and the tumor again progresses.
Increasingly, chemotherapy is being used as an effective first-line
treatment for HRPC. However, it is not a cure, and so this is creating a
need for effective therapeutic options for these patients once they have
progressed.
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum
family of compounds. Over the past two decades, platinum-based drugs have
become a critical part of modern chemotherapy treatments and are used to
treat a wide variety of cancers. Unlike the platinum drugs currently on the
market, all of which require intravenous administration, satraplatin is an
orally bioavailable compound and is given as capsules that patients can
take at home.
In September 2006, GPC Biotech announced topline results for the
double- blinded, randomized satraplatin Phase 3 registrational trial, the
SPARC trial (Satraplatin and Prednisone Against Refractory Cancer). The
trial is evaluating satraplatin plus prednisone versus placebo plus
prednisone as a second-line treatment in 950 patients with
hormone-refractory prostate cancer. 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.
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. GPC Biotech in-licensed
satraplatin from Spectrum Pharmaceuticals, Inc. in 2002. Additional
information on satraplatin can be found in the Anticancer Programs section
of the Company's Web site at http://www.gpc-biotech.com.
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 an oral platinum-based
compound that is being evaluated as a second-line chemotherapy treatment in
hormone-refractory prostate cancer. The U.S. FDA has granted fast track
designation to satraplatin for this indication, and the rolling NDA
submission process for this compound has been completed. 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 its wholly owned U.S.
subsidiary has sites in Waltham, Massachusetts and 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.
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, 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, even if these
results are confirmed upon full analysis of the trial, 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 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 GPC Biotech. Forward-looking statements
speak only as of the date on which they are made and GPC Biotech does not
undertake any obligation to update these forward- looking statements, even
if new information becomes available in the future.
The scientific information discussed in this press release related to
satraplatin is preliminary and investigative. 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.
For further information, please contact:
GPC Biotech AG
Martin Braendle
Director, 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: +1 781-890-9007 X267
usinvestors@gpc-biotech.com
Additional Media Contacts:
In Europe:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.:
Noonan Russo
David Schull
Phone: +1 212-845-4271
david.schull@eurorscg.com
SOURCE GPC Biotech
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Related links:
http://www.gpc-biotech.com
http://www.speratrial.com
CONTACT:
Martin Braendle, Director, Investor Relations
& Corporate Communications, +49-89-8565-2693, ir@gpc-biotech.com,
or Laurie Doyle, Director, Investor Relations & Corporate
Communications, +1-781-890-9007 ext. 267,
usinvestors@gpc-biotech.com, both of GPC Biotech AG; or In the
U.S.: David Schull of Noonan Russo, +1-212-845-4271,
david.schull@eurorscg.com; or In Europe: Brian Hudspith of
Maitland Noonan Russo, +44-20-7379-5151, bhudspith@maitland.co.uk
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