GPC Biotech AG (Frankfurt Stock Exchange: GPC;
TecDAX index; Nasdaq: GPCB) today announced the presentation of preliminary
clinical data on its anticancer monoclonal antibody 1D09C3 at the 48th
Annual Meeting of the American Society of Hematology (ASH) in Orlando,
Florida. 1D09C3 is currently in a Phase 1 clinical program that is
evaluating the antibody in patients with relapsed or refractory B-cell
lymphomas, who have failed prior standard therapy. The objectives of the
Phase 1 program are to determine the maximum tolerated dose and to
establish a recommended dose for a Phase 2 efficacy trial.
The poster entitled, "Two Phase 1 Open-Label Studies of the Fully Human
IgG4 Monoclonal Antibody 1D09C3 in Patients with Relapsed and/or Refractory
B- Cell Lymphoproliferative Neoplasias on a Weekly and Bi-Weekly Dosing
Scheme," (Abstract #2730) presented initial results from the ongoing Phase
1 clinical program. These preliminary data from 25 patients suggest that
1D09C3 is well tolerated in this heavily pre-treated patient population. A
maximum tolerated dose had not yet been reached. Hints of antitumor
activity were observed in two patients.
"We are pleased with the initial clinical data from our antibody
program," said Marcel Rozencweig, M.D., Senior Vice President, Drug
Development and Chief Medical Officer. "Importantly, 1D09C3 seems to be
well tolerated by this heavily pre-treated patient population. The early
signs of anti-tumor activity are encouraging at these low doses. We expect
to see the final results from our Phase 1 clinical program in mid 2007.
Should the data continue to be promising, we anticipate moving into Phase 2
testing thereafter."
Dr. Rozencweig continued: "While good progress has been made in recent
years in treating lymphoid cancers with antibodies, there remains a major
need for additional therapies to treat patients who have relapsed or become
resistant to currently available treatments. 1D09C3 has key attributes
differentiating it from marketed therapies; thus, it could hold the
potential to become an important new therapy for treating lymphomas and
leukemias."
New preclinical data under the title "Interferon-Gamma Enhances the
Anti-Myeloma Activity of the Fully Human Anti-HLA-DR Monoclonal Antibody
1D09C3" (Abstract #656) will also be presented. The findings suggest that
interferon-gamma induces up-regulation of HLA-DR, the target of 1D09C3,
resulting in a potent enhancement of the in vivo anti-myeloma activity of
1D09C3.
About 1D09C3
1D09C3 is an anti-MHC (major histocompatibility complex) class II
monoclonal antibody. The antibody was isolated in collaboration with
MorphoSys from its HuCAL(R) library of human antibodies. 1D09C3 binds to
MHC class II molecules on the cell surface and selectively kills activated,
proliferating tumor cells, which include B-cell and T-cell lymphomas. In
2005, it was estimated that more than 56,000 people in the U.S. and about
70,000 people in the European Union were diagnosed with non-Hodgkin's
lymphoma, the most common form of lymphoma. In preclinical studies 1D09C3
has been shown to induce programmed cell death and does not require a
functioning immune system for its cell-killing effect. A Phase 1 clinical
program evaluating 1D09C3 in patients with relapsed or refractory B-cell
lymphomas, such as Hodgkin's and non- Hodgkin's lymphomas and chronic
lymphocytic leukemia (CLL), who have failed prior standard therapy, is
currently underway at major cancer centers in Europe. 1D09C3 has been
granted orphan medicinal product designation in the European Union for the
treatment of Hodgkin's lymphoma, chronic lymphocytic leukemia and multiple
myeloma. Additional information on 1D09C3 can be found in the Anticancer
Programs section of the Company's Web site at gpc-biotech.
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 -- satraplatin -- is an oral
platinum-based compound that has shown highly statistically significant
results for progression-free survival 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 the rolling NDA submission process for this compound is
underway. GPC Biotech in-licensed satraplatin from Spectrum
Pharmaceuticals, Inc. in 2002. 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 gpc-biotech.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC Biotech AG,
including summary statements relating to topline results of the SPARC
trial, initial clinical results with the 1D09C3 monoclonal antibody and
summary statements relating to the potential efficacy and safety profile of
satraplatin and of 1D09C3. 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, there can be no
guarantee that results from the clinical trials discussed in this press
release will be confirmed upon full or final analysis of the results of the
trials and additional information relating to the safety, efficacy or
tolerability of satraplatin or of 1D09C3 may be discovered upon further
data analysis. We cannot guarantee that satraplatin or 1D09C3 will be
approved for marketing in a timely manner, if at all, by regulatory
authorities nor that, if marketed, either product will be a commercial
success . 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 and to 1D09C3 is preliminary and investigative. Neither
satraplatin nor 1D09C3 has 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 and 1D09C3 are
safe and effective for the use(s) being investigated.
TecDAX index; Nasdaq: GPCB) today announced the presentation of preliminary
clinical data on its anticancer monoclonal antibody 1D09C3 at the 48th
Annual Meeting of the American Society of Hematology (ASH) in Orlando,
Florida. 1D09C3 is currently in a Phase 1 clinical program that is
evaluating the antibody in patients with relapsed or refractory B-cell
lymphomas, who have failed prior standard therapy. The objectives of the
Phase 1 program are to determine the maximum tolerated dose and to
establish a recommended dose for a Phase 2 efficacy trial.
The poster entitled, "Two Phase 1 Open-Label Studies of the Fully Human
IgG4 Monoclonal Antibody 1D09C3 in Patients with Relapsed and/or Refractory
B- Cell Lymphoproliferative Neoplasias on a Weekly and Bi-Weekly Dosing
Scheme," (Abstract #2730) presented initial results from the ongoing Phase
1 clinical program. These preliminary data from 25 patients suggest that
1D09C3 is well tolerated in this heavily pre-treated patient population. A
maximum tolerated dose had not yet been reached. Hints of antitumor
activity were observed in two patients.
"We are pleased with the initial clinical data from our antibody
program," said Marcel Rozencweig, M.D., Senior Vice President, Drug
Development and Chief Medical Officer. "Importantly, 1D09C3 seems to be
well tolerated by this heavily pre-treated patient population. The early
signs of anti-tumor activity are encouraging at these low doses. We expect
to see the final results from our Phase 1 clinical program in mid 2007.
Should the data continue to be promising, we anticipate moving into Phase 2
testing thereafter."
Dr. Rozencweig continued: "While good progress has been made in recent
years in treating lymphoid cancers with antibodies, there remains a major
need for additional therapies to treat patients who have relapsed or become
resistant to currently available treatments. 1D09C3 has key attributes
differentiating it from marketed therapies; thus, it could hold the
potential to become an important new therapy for treating lymphomas and
leukemias."
New preclinical data under the title "Interferon-Gamma Enhances the
Anti-Myeloma Activity of the Fully Human Anti-HLA-DR Monoclonal Antibody
1D09C3" (Abstract #656) will also be presented. The findings suggest that
interferon-gamma induces up-regulation of HLA-DR, the target of 1D09C3,
resulting in a potent enhancement of the in vivo anti-myeloma activity of
1D09C3.
About 1D09C3
1D09C3 is an anti-MHC (major histocompatibility complex) class II
monoclonal antibody. The antibody was isolated in collaboration with
MorphoSys from its HuCAL(R) library of human antibodies. 1D09C3 binds to
MHC class II molecules on the cell surface and selectively kills activated,
proliferating tumor cells, which include B-cell and T-cell lymphomas. In
2005, it was estimated that more than 56,000 people in the U.S. and about
70,000 people in the European Union were diagnosed with non-Hodgkin's
lymphoma, the most common form of lymphoma. In preclinical studies 1D09C3
has been shown to induce programmed cell death and does not require a
functioning immune system for its cell-killing effect. A Phase 1 clinical
program evaluating 1D09C3 in patients with relapsed or refractory B-cell
lymphomas, such as Hodgkin's and non- Hodgkin's lymphomas and chronic
lymphocytic leukemia (CLL), who have failed prior standard therapy, is
currently underway at major cancer centers in Europe. 1D09C3 has been
granted orphan medicinal product designation in the European Union for the
treatment of Hodgkin's lymphoma, chronic lymphocytic leukemia and multiple
myeloma. Additional information on 1D09C3 can be found in the Anticancer
Programs section of the Company's Web site at gpc-biotech.
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 -- satraplatin -- is an oral
platinum-based compound that has shown highly statistically significant
results for progression-free survival 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 the rolling NDA submission process for this compound is
underway. GPC Biotech in-licensed satraplatin from Spectrum
Pharmaceuticals, Inc. in 2002. 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 gpc-biotech.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC Biotech AG,
including summary statements relating to topline results of the SPARC
trial, initial clinical results with the 1D09C3 monoclonal antibody and
summary statements relating to the potential efficacy and safety profile of
satraplatin and of 1D09C3. 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, there can be no
guarantee that results from the clinical trials discussed in this press
release will be confirmed upon full or final analysis of the results of the
trials and additional information relating to the safety, efficacy or
tolerability of satraplatin or of 1D09C3 may be discovered upon further
data analysis. We cannot guarantee that satraplatin or 1D09C3 will be
approved for marketing in a timely manner, if at all, by regulatory
authorities nor that, if marketed, either product will be a commercial
success . 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 and to 1D09C3 is preliminary and investigative. Neither
satraplatin nor 1D09C3 has 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 and 1D09C3 are
safe and effective for the use(s) being investigated.
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