New Preclinical Data on Efficacy of Satraplatin in Prostate Cancer Cells
And With Taxotere(R) Also Presented
MARTINSRIED/MUNICH, Germany, Feb. 27 /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
and preclinical data on its lead drug candidate satraplatin at the ASCO
Prostate Cancer Symposium: A Multidisciplinary Approach in San Francisco,
California.
A poster entitled, "A Phase I Pharmacokinetic (PK)/Food Effect and Safety
Study of Satraplatin," presented data from a study involving seventeen
patients with advanced solid tumors. Most patients in the study were heavily
pre-treated: the median number of prior chemotherapy treatments was three.
Satraplatin appeared to be well tolerated, with no significant cardio-, renal,
liver or neurological toxicities observed. Other common toxicities like
nausea, vomiting and diarrhea were mild to moderate and were reported to be
controlled with prophylactic oral anti-emetic therapy. Seven patients in the
study had hormone-refractory prostate cancer (HRPC), and all of the HRPC
patients had received Taxotere(R) (docetaxel), with a median of three prior
chemotherapy regimens. Satraplatin showed evidence of anti-tumor activity in
this group: one patient had a partial response (RECIST criteria), and two
patients had prolonged stable disease (durations of 3.5 and five months).
The study was designed to evaluate the effect of food on the
bioavailability (i.e., the rate at which the drug is absorbed and the amount
of drug absorbed) of satraplatin. Such data are useful in determining the best
way for patients to take an oral drug. In this study, the peak plasma
concentrations of satraplatin were decreased by approximately 20% following a
high fat meal; however, the total amount of drug absorbed was not affected by
food. The clinical implications of the reduced peak drug concentrations in
the face of equivalent total amounts of drug absorbed in patients taking
satraplatin following a high fat meal are not known.
A second poster entitled, "Efficacy of Satraplatin, an Oral Platinum
Analogue in Prostate Cancer: Synergistic Activity with Docetaxel," reviewed
the preclinical results of studies evaluating the cell-killing effect of
satraplatin and its metabolite on prostate cancer cells. In vivo and in vitro
data showed that satraplatin and its active metabolite, JM-118, inhibited the
growth of prostate cancer cells in a dose-dependent fashion. In addition, when
satraplatin or JM-118 was combined in vitro with Taxotere, a synergistic
effect was demonstrated in prostate cancer cells. This synergistic effect was
strongest when Taxotere was followed by JM-118.
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.
An oral platinum drug could offer key advantages, including ease of
administration and patient convenience, in a variety of applications. GPC
Biotech believes that satraplatin is also the only platinum compound that has
demonstrated activity in a randomized trial in HRPC.
GPC Biotech has completed patient enrollment in a Phase 3 registrational
trial -- the SPARC trial -- which is assessing the safety and efficacy of
satraplatin in combination with prednisone as a second-line chemotherapy in
patients with HRPC. In December 2005, the Company initiated the rolling
submission of a New Drug Application (NDA) with the U.S. Food and Drug
Administration (FDA). Also in December 2005, GPC Biotech signed a co-
development and licensing agreement with Pharmion for 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 HRPC, ovarian cancer and
small cell lung cancer. Other trials evaluated the effects of adding
satraplatin to radiation therapy, a clinical application in which
satraplatin's oral bioavailability could be particularly advantageous. A
Phase 1/2 study evaluating this combination in patients with non-small cell
lung cancer has been initiated. Several other Phase 1 and 2 studies
evaluating satraplatin in combination with other therapies and in various
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 projections or estimates about plans and
objectives relating to our future operations, products, or services; future
financial results; or assumptions underlying or relating to any such
statements. These statements are forward-looking and are subject to risks and
uncertainties, many of which are beyond our control. Actual results could
differ materially depending on a number of factors, including the timing and
effects of regulatory actions, the results of clinical trials, the Company's
relative success developing and gaining market acceptance for any new
products, and the effectiveness of patent protection. There can be no
guarantee that satraplatin will be approved for marketing in a timely manner,
if at all. We direct you to the Company's Annual Report on Form 20-F, as
amended, for the fiscal year ended December 31, 2004 and other reports filed
with the U.S. Securities and Exchange Commission for additional details on the
important factors that may affect the Company's future results, performance
and achievements. The Company disclaims any intent or obligation to update
these forward-looking statements or the factors that may affect the Company's
future results, performance or achievements, even if new information becomes
available in the future.
Taxotere(R) (docetaxel) is a registered trademark of the sanofi-aventis
group.
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 Contact:
Maitland Noonan Russo
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
SOURCE GPC Biotech A
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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, or
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
Europe: Brian Hudspith of Maitland Noonan Russo, +44 (0)20 7379
5151, bhudspith@maitland.co.uk
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