MARTINSRIED/MUNICH, Germany, June 6 /PRNewswire-FirstCall/ -- WALTHAM,
Mass. and PRINCETON, N.J. -- GPC Biotech AG (Frankfurt Stock Exchange: GPC;
TecDAX index; Nasdaq: GPCB) today announced the presentation of new
clinical data on its lead drug candidate satraplatin, currently in a fully
enrolled Phase 3 trial, at the Annual Meeting of the American Society of
Clinical Oncology (ASCO) in Atlanta, Georgia.
A poster entitled, "Phase 1 Study of the Effects of Hepatic Impairment
on the Pharmacokinetics (PK) and Safety of Satraplatin in Patients with
Refractory Non-Hematologic Cancer," presented study data on 19 patients
with advanced solid tumors and with varying degrees of hepatic impairment
(reduced liver function). The study was designed to show the effect of
hepatic impairment on the pharmacokinetics of satraplatin in patients with
advanced forms of cancer. Most patients in the study were heavily
pre-treated. As this study is still ongoing, the data reported are
considered preliminary. Satraplatin appears to be well tolerated in
patients with mild to moderate liver impairment. As expected, the main
toxicities observed thus far have been hematologic -- anemia,
thrombocytopenia (decrease in platelets in the blood) and neutropenia
(decrease in white blood cells). Non-hematologic toxicities like diarrhea,
anorexia, and fatigue have been mild. No significant cardio-, liver or
neurological toxicities have yet been observed.
A second poster entitled, "Phase 1 Study of the Effects of Renal
Impairment on the Pharmacokinetics and Safety of Satraplatin in Patients
with Refractory Non-Hematologic Cancer," presented study data on 24
patients with advanced solid tumors and with varying degrees of renal
impairment (reduced kidney function). The study was designed to show the
effect of renal impairment on the pharmacokinetics of satraplatin in
patients with advanced forms of cancer. As this study is still ongoing, the
data reported are considered preliminary. Satraplatin appears to be well
tolerated in these patients. As expected, the main hematological toxicities
observed to date have been anemia and thrombocytopenia. Common toxicities
like nausea, vomiting, diarrhea, fatigue and anorexia have to date been
mild. No significant cardio-, renal, liver or neurological toxicities have
yet been observed.
As patients with advanced cancer may often have limited function of the
liver and/or kidneys, it is important to understand how these impairments
affect how a drug is used by the body. The results of these two studies
should help clinicians understand the tolerability and appropriate dosing
of satraplatin in cancer patients whose liver or kidney function are
compromised.
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 December 2005, GPC Biotech completed accrual to the SPARC trial that
is evaluating satraplatin in combination with prednisone as second-line
chemotherapy in patients with hormone refractory prostate cancer. Also in
December 2005, GPC Biotech initiated the rolling submission of a New Drug
Application (NDA) for satraplatin with the U.S. Food and Drug
Administration (FDA) and GPC Biotech signed a co-development and license
agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion
Corporation, under which Pharmion was granted exclusive commercialization
rights to satraplatin for Europe and certain other territories.
Satraplatin has been studied in clinical trials involving a range of
tumors, and Phase 2 trials have been completed in hormone-refractory
prostate cancer, ovarian cancer and small cell lung cancer. Other trials
evaluating the effects of satraplatin in combination with radiation
therapy, in combination with other cancer therapies and in various other
cancers 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 biopharmaceutical company discovering and
developing new anticancer drugs. The Company's lead product candidate --
satraplatin -- has achieved target enrollment in a Phase 3 registrational
trial 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 GPC Biotech has begun the rolling NDA
submission process for this compound. 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). The Company's wholly owned U.S. subsidiary has sites in Waltham,
Massachusetts and Princeton, New Jersey. For additional information, please
visit the Company's Web site at http://www.gpc-biotech.com.
This press release may contain forward-looking statements, including,
without limitation, statements about the progress and results of the
outcome of the SPARC trial and other clinical development activities,
regulatory processes and commercialization efforts for satraplatin.
Forward-looking statements are based on the Company's current expectations
and projections about future events and are subject to risks, uncertainties
and assumptions in light of which the forward-looking events discussed in
this press release might not occur. We direct you to the Company's 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 these statements and the Company's
future results, performance and achievements. Readers are cautioned not to
place undue reliance on these forward-looking statements that speak only as
of the date of this release. Except as required by law, the Company does
not undertake any obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.
For further information, please contact:
GPC Biotech AG
Fraunhoferstr. 20
82152 Martinsried/Munich, Germany
Martin Braendle
Associate Director, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565-2693
ir@gpc-biotech.com
In the U.S.:
Laurie Doyle
Associate Director, Investor Relations & Corporate Communications
Phone: +1 781 890 9007 X267
usinvestors@gpc-biotech.com
Additional Media Contacts:
In the U.S.:
Euro RSCG Life NRP
Matt Haines
Phone: +1 212 845 4235
matthew.haines@eurorscg.com
In Europe:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com
CONTACT:
Martin Braendle, Associate Director, Investor
Relations & Corporate Communications, +49 (0)89 8565-2693,
ir@gpc-biotech.com, or Laurie Doyle, Associate 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.: Matt Haines of Euro RSCG Life NRP, +1-212-845-4235,
matthew.haines@eurorscg.com; or In Europe: Brian Hudspith of
Maitland Noonan Russo, +44 (0)20 7379 5151,
bhudspith@maitland.co.uk
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