New Data from Several Satraplatin Clinical Trials in Solid Tumors Presented at 44th ASCO Annual Meeting
02 6월 2008 - 4:05PM
Business Wire
GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) today
announced the presentation of data from several satraplatin
clinical trials at the 44th Annual Meeting of the American Society
for Clinical Oncology (ASCO) in Chicago. �We are pleased that data
from several satraplatin clinical trials evaluating satraplatin in
combination with a variety of widely used cancer treatments were
selected for presentation at this year�s ASCO Annual Meeting,� said
Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer of GPC
Biotech. �The information gained from these studies is helpful to
GPC Biotech and others as we plan new trials with this active oral
platinum-based compound.� The following are summaries of the
highlighted presentations. Phase I study of satraplatin and
docetaxel in solid malignancies - Ticiana B Leal, MD, (Abstract
#2570) The primary objective of this study was to determine the
maximum tolerated dose (MTD) of satraplatin and docetaxel
(Taxotere�) in patients with advanced solid tumors when docetaxel
was administered every three weeks. Twenty-three patients were
enrolled in the study. The patient population was heavily
pre-treated, with a median of two prior cytotoxic chemotherapy
regimens. The recommended Phase II dose was satraplatin at
40mg/m2/day given on days 1-5 and docetaxel at 60mg/m2 given on day
1 of a three-week cycle, without G-CSF, and satraplatin at
50mg/m2/day given on days 1-5 and docetaxel at 70mg/m2 given on day
1 of a three-week cycle with G-CSF. G-CSF is used to promote the
recovery of white blood cells. The most commonly reported adverse
event was neutropenia (decrease in white blood cells) in 22% of
patients, followed by anemia, diarrhea and fatigue. Preliminary
data show encouraging activity in men with high-grade androgen
independent prostate cancer. As a result, this combination is
currently being further explored in men with chemo-na�ve, androgen
independent prostate cancer. Phase I study of the oral platinum
agent satraplatin in sequential combination with capecitabine in
patients with advanced solid tumours - Cristiana Sessa, MD
(Abstract #2560) The primary objective of this study was to
determine the MTD and Phase 2 recommended dose for satraplatin
administered sequentially with capecitabine (Xeloda�). Thirty-seven
patients with a variety of solid tumors were treated in the study.
The MTD and recommended dose for Phase 2 was satraplatin at 70
mg/m2 and capecitabine at 1000 mg/m2/BID (twice daily).
Hematological toxicity was the main dose-limiting toxicity. In the
34 patients who were evaluated, there were three confirmed partial
responses � two in platinum-sensitive ovarian cancer and one in
prostate cancer patients, as well as six stable disease in prostate
cancer patients. These preliminary results suggest that the
sequential administration of satraplatin and capecitabine may
represent a well tolerated and convenient oral treatment for
patients with advanced solid tumors. Phase I study of oral platinum
with concurrent radiation therapy in non small cell lung cancer �
Hak Choy, MD (Abstract #7560) The objectives of this study were to
determine the dose-limiting toxicities, MTD and recommended Phase 2
dose of satraplatin in combination with radiation therapy for
patients with non-small cell lung cancer (NSCLC). Fifteen patients
were enrolled in the study. The recommended Phase 2 dose for this
patient population is 30 mg/d each day of radiation treatment. Dose
limiting toxicities were Grade 3 pneumonia and Grade 3 elevated
liver function. Of the eleven evaluable patients, eight had partial
responses and three had stable disease. These results suggest
therapeutic synergy of satraplatin in combination with radiation
for the treatment of NSCLC and provide a rationale for future
studies with this combination. Satraplatin in patients with
advanced hormone-refractory prostate cancer: Overall survival
results from the phase III satraplatin and prednisone against
refractory cancer (SPARC) trial, A. Oliver Sartor, MD (Abstract
#5003) Data from this oral presentation are discussed in a separate
press release issued by GPC Biotech on June 2, 2008. Additional
data on satraplatin and on RGB-286638 broad-spectrum kinase
inhibitor published in ASCO Annual Meeting Proceedings The Company
also reported that data from two other satraplatin clinical trials,
as well as in vitro data in multiple myeloma with the RGB-286638
kinase inhibitor, were published in the ASCO Annual Meeting
Proceedings. Cirstea, Diana et al, �Pleiotropic Activity of the
Novel Cyclin-Dependent Kinase Inhibitor RGB 286638 Predicts
Therapeutic Potential in Multiple Myeloma.� Researchers assessed
the effect of RGB-286638, a novel broad-spectrum kinase inhibitor,
on inhibiting tumor growth in conventional drug-sensitive and
drug-resistant multiple myeloma cell lines and primary tumor cells
from multiple myeloma patients. The results demonstrated that
RGB-286638 induces multiple myeloma cell death via the inhibition
of cyclin-dependent kinase/cyclin complexes and cell cycle
progression. In vivo studies are ongoing to assist in the design of
clinical testing for RGB-286638 in multiple myeloma. Spigel, D R et
al, �Phase II Trial of Satraplatin (S) and Paclitaxel (P) in
First-Line Advanced Non-Small Cell Lung Cancer (NSCLC) Treatment:
Final Results.� This abstract reviewed the final results from the
Phase 2 trial evaluating satraplatin plus paclitaxel (Taxol�) in
patients with NSCLC. Thirty-eight patients with newly-diagnosed
NSCLC were enrolled in the study, and 28 patients were evaluable.
One complete response and six partial responses were observed
(25.9% overall response rate). The regimen was well tolerated and
associated with limited Grade 3/4 toxicity when satraplatin was
administered at 70 mg/m2 on days 1-5 every 28 days. The results
indicate that satraplatin appears to have activity that is similar
to other platinum agents when combined with paclitaxel in
first-line NSCLC treatment. Wisinski, K B et al, �A phase I study
of the oral platinum agent satraplatin (S) with capecitabine (C) in
patients (pts) with advanced solid malignancies.� This abstract
discussed results from a Phase 1 study evaluating the combination
of satraplatin and capecitabine administered concurrently.
Twenty-two patients were enrolled in the study. The dose-limiting
toxicities were predominantly Grade 3/4 thrombocytopenia. The MTD
for satraplatin was 100 mg/m2 on days 1-5. No responses were
observed, and there was significant toxicity when these two
compounds were administered together. [Abstract on data from trial
evaluating sequential administration of satraplatin with
capecitabine discussed earlier in this release.] 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 oral compound that
clinical trial patients are able to take at home. A Marketing
Authorization Application for satraplatin in combination with
prednisone is currently under review in Europe for the treatment of
hormone-refractory prostate cancer patients whose prior
chemotherapy has failed. A decision on the filing by the European
regulators is expected in the second half of 2008. Celgene
Corporation is responsible for the regulatory filings for
satraplatin and its development and commercialization for Europe
and certain other territories. GPC Biotech also has a license
agreement with Yakult Honsha Co. Ltd. under which Yakult has
exclusive commercialization rights to satraplatin for Japan and is
taking the lead in developing the drug in that territory. GPC
Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc.
in 2002. About RGB-286638 broad spectrum kinase inhibitor
RGB-286638 is a novel, broad-spectrum kinase inhibitor. The
compound has been shown in vitro to lead to the inhibition of the
cell cycle, targeting all relevant cyclin-dependent kinases, and to
the induction of apoptosis (programmed cell death). RGB-286638 also
inhibits other major kinases that are important in controlling the
proliferation of cancer cells. In a range of pre-clinical models in
both solid and liquid tumors, this small molecule resulted in tumor
regression and increased survival. The program is expected to enter
the clinic during 2008. Clinical trials are planned in both solid
and hematological tumors in Europe and the U.S. About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company
focused on 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
in Princeton, New Jersey. For additional information, please visit
GPC Biotech's Web site at www.gpc-biotech.com. This press release
contains forward-looking statements, which express the current
beliefs and expectations of the management of GPC Biotech,
including statements about the efficacy and safety of satraplatin
and the development of RGB-286638. 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. Satraplatin may not be
approved for marketing in a timely manner, if at all. We direct you
to GPC Biotech�s Annual Report on Form 20-F for the fiscal year
ended December 31, 2006 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
undertakes no obligation to update these forward-looking
statements, even if new information becomes available in the
future. Satraplatin has not 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� is a registered trademark of Aventis
Pharma S.A. Xeloda� is a registered trademark of Hoffmann-LaRoche
AG. Taxol� is a registered trademark of Bristol-Myers Squibb
Company.
Gpc Biotech AG ADS (MM) (NASDAQ:GPCB)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Gpc Biotech AG ADS (MM) (NASDAQ:GPCB)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024