, GlobeNewswire
Micromet Presents Data at ESMO 2008 on Anti- EpCAM Antibody Adecatumumab (MT201) in Combination with Chemotherapy
Corporate news- Mitteilung verarbeitet und übermittelt durch Hugin.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
----------------------------------------------------------------------
--------------
Interim data from Phase 1b Study indicate that adecatumumab in
combination with docetaxel is safe and well tolerated and suggest a
better outcome for breast cancer patients with high EpCAM expression
BETHESDA, MD - September 15, 2008 -- Micromet, Inc. (Nasdaq: MITI), a
biopharmaceutical company developing novel, proprietary antibodies
for the treatment of cancer, inflammation and autoimmune diseases,
presented interim data from a study investigating its anti-EpCAM
antibody adecatumumab (MT201) in combination with the
chemotherapeutic docetaxel[1] on Saturday, September 13 at the 2008
meeting of the European Society of Medical Oncology (ESMO) held in
Stockholm, Sweden.
Adecatumumab is an antibody that targets EpCAM, a tumor antigen known
to be associated with poor prognosis for many solid cancers. A
previous phase 2 trial investigating adecatumumab as a single agent
in patients with metastatic breast cancer (MBC) suggested that
treatment with adecatumumab was associated with fewer new metastases
in patients with high EpCAM expression compared to patients with low
EpCAM expression[2].
The ongoing phase 1b clinical trial presented at ESMO investigated
the safety and tolerability of increasing doses of adecatumumab in
combination with standard chemotherapy docetaxel in relapsed MBC
patients who had a median of three prior chemotherapy regimens.
Combining adecatumumab with docetaxel appears to be feasible with
clinically manageable diarrhea being the main toxicity at higher
doses. Other frequently observed adverse events included nausea,
vomiting, stomatitis, constipation, fatigue, fever and chills. No
increase in adverse events or laboratory abnormalities typically seen
with docetaxel was observed.
The overall response rate according to RECIST has been reported to be
43 percent in patients with high expression of EpCAM, the target of
adecatumumab (3 of 7 patients), whereas no responses were detected in
patients with low EpCAM expression (0 of 8 patients).
"These data demonstrate that adding adecatumumab to standard
chemotherapy is feasible and suggest that the combination with
taxanes could be a valuable treatment option for patients with high
EpCAM expression," said Carsten Reinhardt, M.D., Ph.D., senior vice
president and chief medical officer for Micromet. "The trend for a
better outcome in patients with high EpCAM expression levels is in
line with earlier observations and suggests a truly targeted effect
of adecatumumab against EpCAM-positive tumor cells."
In addition to the continued clinical development in patients with
breast cancer, Micromet is also in the process of setting up a
randomized phase 2 clinical trial in patients suffering from
colorectal cancer (CRC) after complete resection of first liver
metastases.
[1] First results from a Phase 1b study of the anti-EpCAM antibody
adecatumumab (MT201) in combination with docetaxel in patients with
metastatic breast cancer. M. Schuler et al. ESMO Meeting Abstract,
Sep 2008; Abstract 485P.
[2] Highly reduced incidence of new breast cancer metastases during
treatment with adecatumumab appears to be the major factor for longer
time to tumor progression in patients with high-level EpCAM
expression Ch. Dittrich et al. AACR Meeting Abstract, Oct 2007; A71.
About ESMO
The European Society for Medical Oncology (ESMO) is the leading
European non-profit professional organization for medical oncology,
with a focus on promoting multidisciplinary cancer treatment around
the world.
Since its founding in 1975, ESMO has continuously expanded its
mission, aiming to create a wider community of people involved in the
multifaceted aspects and phases of cancer: a community of
professionals who share the common goal of providing optimal care to
all cancer patients.
Through the years, the Society has strived to meet the needs of both
oncologists and patients. For oncology professionals, ESMO serves and
offers support to its members in their daily practice and careers by
sharing knowledge and expertise through scientific and educational
activities. For patients, ESMO partners with cancer patient
associations and
(more) Page 2 of 5
groups, by promoting direct and pro-active involvement of patients in
educational, political, and networking activities. For the benefit of
both, professionals and patients, in
2006 ESMO became active at the political level in order to influence
issues which could impact the oncology community.
About Micromet, Inc.
Micromet, Inc. (www.micromet-inc.com) is a biopharmaceutical company
developing novel, proprietary antibodies for the treatment of cancer,
inflammation and autoimmune diseases. Four of its antibodies are
currently in clinical trials, while the remainder of the product
pipeline is in preclinical development. The BiTE® antibody
blinatumomab (MT103/MEDI-538) is in a phase 2 clinical trial for the
treatment of patients with acute lymphoblastic leukemia and in a
phase 1 clinical trial for the treatment of patients with
non-Hodgkin's lymphoma. BiTE antibodies represent a new class of
antibodies that activate a patient's own cytotoxic T cells,
considered the most powerful "killer cells" of the human immune
system, to eliminate cancer cells. Micromet is developing
blinatumomab in collaboration with MedImmune, Inc., a subsidiary of
AstraZeneca plc. MT110 is the second BiTE antibody in clinical
trials, and is being developed by Micromet in a phase 1 clinical
trial for the treatment of patients with lung or gastrointestinal
cancer. The third clinical stage antibody is adecatumumab, also known
as MT201, a human monoclonal antibody that targets epithelial cell
adhesion molecule (EpCAM)-expressing solid tumors. Micromet is
developing adecatumumab in collaboration with Merck Serono in a phase
1b clinical trial evaluating adecatumumab in combination with
docetaxel for the treatment of patients with metastatic breast
cancer. The fourth clinical stage antibody is MT293 which is licensed
to TRACON Pharmaceuticals, Inc. and is being developed in a phase 1
clinical trial for the treatment of patients with cancer. Three
additional BiTE antibodies, targeting CD33, CEA and MCSP,
respectively, are in preclinical development. In addition, Micromet
has established a collaboration with Nycomed for the development and
commercialization of MT203, a human antibody neutralizing the
activity of granulocyte/macrophage colony stimulating factor
(GM-CSF), which has potential applications in the treatment of
various inflammatory and autoimmune diseases, such as rheumatoid
arthritis, psoriasis, or multiple sclerosis.
(more) Page 3 of 5
Forward-Looking Statements
This release contains certain forward-looking statements that involve
risks and uncertainties that could cause actual results to be
materially different from historical results or from any future
results expressed or implied by such forward-looking statements.
These forward-looking statements include statements regarding the
efficacy, safety and intended utilization of our product candidates,
the development of our BiTE antibody technology, the conduct, timing
and results of future clinical trials, expectations of the future
expansion of our product pipeline and collaborations, and our plans
regarding future presentations of clinical data. You are urged to
consider statements that include the words "ongoing," "may," "will,"
"believes," "potential," "expects," "plans," "anticipates,"
"intends," or the negative of those words or other similar words to
be uncertain and forward-looking. Factors that may cause actual
results to differ materially from any future results expressed or
implied by any forward-looking statements include the risk that
product candidates that appeared promising in early research,
preclinical studies or clinical trials do not demonstrate safety
and/or efficacy in subsequent clinical trials, the risk that
encouraging results from early research, preclinical studies or
clinical trials may not be confirmed upon further analysis of the
detailed results of such research, preclinical study or clinical
trial, the risk that additional information relating to the safety,
efficacy or tolerability of our product candidates may be discovered
upon further analysis of preclinical or clinical trial data, the risk
that we or our collaborators will not obtain approval to market our
product candidates, the risks associated with reliance on outside
financing to meet capital requirements, and the risks associated with
reliance on collaborators, including MedImmune, Merck Serono, TRACON
and Nycomed, for the funding or conduct of further development and
commercialization activities relating to our product candidates.
These factors and others are more fully discussed in Micromet's
Annual Report on Form 10-K for the fiscal year ended December 31,
2007, filed with the SEC on March 14, 2008, as well as other filings
by the company with the SEC.
Any forward-looking statements are made pursuant to Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, and, as such, speak only
as of the date made. Micromet, Inc. undertakes no obligation to
publicly update any forward-looking statements, whether as a result
of new information, future events or otherwise.
# # #
Contact Information
US Media: European Media:
Andrea tenBroek/Chris Stamm Ludger Wess
(781)-684-0770 +49 (40) 8816 5964
micromet@schwartz-pr.com ludger@akampion.com
US Investors: European Investors:
Susan Noonan Ines-Regina Buth
(212) 966-3650 +49 (30) 2363 2768
susan@sanoonan.com ines@akampion.com
--- Ende der Mitteilung ---
Micromet Inc.
Staffelseestr. 2 München Deutschland
WKN: A0JMQD;
ISIN: US59509C1053;
Notiert: Xetra Stars in Frankfurter Wertpapierbörse;
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
----------------------------------------------------------------------
--------------
Interim data from Phase 1b Study indicate that adecatumumab in
combination with docetaxel is safe and well tolerated and suggest a
better outcome for breast cancer patients with high EpCAM expression
BETHESDA, MD - September 15, 2008 -- Micromet, Inc. (Nasdaq: MITI), a
biopharmaceutical company developing novel, proprietary antibodies
for the treatment of cancer, inflammation and autoimmune diseases,
presented interim data from a study investigating its anti-EpCAM
antibody adecatumumab (MT201) in combination with the
chemotherapeutic docetaxel[1] on Saturday, September 13 at the 2008
meeting of the European Society of Medical Oncology (ESMO) held in
Stockholm, Sweden.
Adecatumumab is an antibody that targets EpCAM, a tumor antigen known
to be associated with poor prognosis for many solid cancers. A
previous phase 2 trial investigating adecatumumab as a single agent
in patients with metastatic breast cancer (MBC) suggested that
treatment with adecatumumab was associated with fewer new metastases
in patients with high EpCAM expression compared to patients with low
EpCAM expression[2].
The ongoing phase 1b clinical trial presented at ESMO investigated
the safety and tolerability of increasing doses of adecatumumab in
combination with standard chemotherapy docetaxel in relapsed MBC
patients who had a median of three prior chemotherapy regimens.
Combining adecatumumab with docetaxel appears to be feasible with
clinically manageable diarrhea being the main toxicity at higher
doses. Other frequently observed adverse events included nausea,
vomiting, stomatitis, constipation, fatigue, fever and chills. No
increase in adverse events or laboratory abnormalities typically seen
with docetaxel was observed.
The overall response rate according to RECIST has been reported to be
43 percent in patients with high expression of EpCAM, the target of
adecatumumab (3 of 7 patients), whereas no responses were detected in
patients with low EpCAM expression (0 of 8 patients).
"These data demonstrate that adding adecatumumab to standard
chemotherapy is feasible and suggest that the combination with
taxanes could be a valuable treatment option for patients with high
EpCAM expression," said Carsten Reinhardt, M.D., Ph.D., senior vice
president and chief medical officer for Micromet. "The trend for a
better outcome in patients with high EpCAM expression levels is in
line with earlier observations and suggests a truly targeted effect
of adecatumumab against EpCAM-positive tumor cells."
In addition to the continued clinical development in patients with
breast cancer, Micromet is also in the process of setting up a
randomized phase 2 clinical trial in patients suffering from
colorectal cancer (CRC) after complete resection of first liver
metastases.
[1] First results from a Phase 1b study of the anti-EpCAM antibody
adecatumumab (MT201) in combination with docetaxel in patients with
metastatic breast cancer. M. Schuler et al. ESMO Meeting Abstract,
Sep 2008; Abstract 485P.
[2] Highly reduced incidence of new breast cancer metastases during
treatment with adecatumumab appears to be the major factor for longer
time to tumor progression in patients with high-level EpCAM
expression Ch. Dittrich et al. AACR Meeting Abstract, Oct 2007; A71.
About ESMO
The European Society for Medical Oncology (ESMO) is the leading
European non-profit professional organization for medical oncology,
with a focus on promoting multidisciplinary cancer treatment around
the world.
Since its founding in 1975, ESMO has continuously expanded its
mission, aiming to create a wider community of people involved in the
multifaceted aspects and phases of cancer: a community of
professionals who share the common goal of providing optimal care to
all cancer patients.
Through the years, the Society has strived to meet the needs of both
oncologists and patients. For oncology professionals, ESMO serves and
offers support to its members in their daily practice and careers by
sharing knowledge and expertise through scientific and educational
activities. For patients, ESMO partners with cancer patient
associations and
(more) Page 2 of 5
groups, by promoting direct and pro-active involvement of patients in
educational, political, and networking activities. For the benefit of
both, professionals and patients, in
2006 ESMO became active at the political level in order to influence
issues which could impact the oncology community.
About Micromet, Inc.
Micromet, Inc. (www.micromet-inc.com) is a biopharmaceutical company
developing novel, proprietary antibodies for the treatment of cancer,
inflammation and autoimmune diseases. Four of its antibodies are
currently in clinical trials, while the remainder of the product
pipeline is in preclinical development. The BiTE® antibody
blinatumomab (MT103/MEDI-538) is in a phase 2 clinical trial for the
treatment of patients with acute lymphoblastic leukemia and in a
phase 1 clinical trial for the treatment of patients with
non-Hodgkin's lymphoma. BiTE antibodies represent a new class of
antibodies that activate a patient's own cytotoxic T cells,
considered the most powerful "killer cells" of the human immune
system, to eliminate cancer cells. Micromet is developing
blinatumomab in collaboration with MedImmune, Inc., a subsidiary of
AstraZeneca plc. MT110 is the second BiTE antibody in clinical
trials, and is being developed by Micromet in a phase 1 clinical
trial for the treatment of patients with lung or gastrointestinal
cancer. The third clinical stage antibody is adecatumumab, also known
as MT201, a human monoclonal antibody that targets epithelial cell
adhesion molecule (EpCAM)-expressing solid tumors. Micromet is
developing adecatumumab in collaboration with Merck Serono in a phase
1b clinical trial evaluating adecatumumab in combination with
docetaxel for the treatment of patients with metastatic breast
cancer. The fourth clinical stage antibody is MT293 which is licensed
to TRACON Pharmaceuticals, Inc. and is being developed in a phase 1
clinical trial for the treatment of patients with cancer. Three
additional BiTE antibodies, targeting CD33, CEA and MCSP,
respectively, are in preclinical development. In addition, Micromet
has established a collaboration with Nycomed for the development and
commercialization of MT203, a human antibody neutralizing the
activity of granulocyte/macrophage colony stimulating factor
(GM-CSF), which has potential applications in the treatment of
various inflammatory and autoimmune diseases, such as rheumatoid
arthritis, psoriasis, or multiple sclerosis.
(more) Page 3 of 5
Forward-Looking Statements
This release contains certain forward-looking statements that involve
risks and uncertainties that could cause actual results to be
materially different from historical results or from any future
results expressed or implied by such forward-looking statements.
These forward-looking statements include statements regarding the
efficacy, safety and intended utilization of our product candidates,
the development of our BiTE antibody technology, the conduct, timing
and results of future clinical trials, expectations of the future
expansion of our product pipeline and collaborations, and our plans
regarding future presentations of clinical data. You are urged to
consider statements that include the words "ongoing," "may," "will,"
"believes," "potential," "expects," "plans," "anticipates,"
"intends," or the negative of those words or other similar words to
be uncertain and forward-looking. Factors that may cause actual
results to differ materially from any future results expressed or
implied by any forward-looking statements include the risk that
product candidates that appeared promising in early research,
preclinical studies or clinical trials do not demonstrate safety
and/or efficacy in subsequent clinical trials, the risk that
encouraging results from early research, preclinical studies or
clinical trials may not be confirmed upon further analysis of the
detailed results of such research, preclinical study or clinical
trial, the risk that additional information relating to the safety,
efficacy or tolerability of our product candidates may be discovered
upon further analysis of preclinical or clinical trial data, the risk
that we or our collaborators will not obtain approval to market our
product candidates, the risks associated with reliance on outside
financing to meet capital requirements, and the risks associated with
reliance on collaborators, including MedImmune, Merck Serono, TRACON
and Nycomed, for the funding or conduct of further development and
commercialization activities relating to our product candidates.
These factors and others are more fully discussed in Micromet's
Annual Report on Form 10-K for the fiscal year ended December 31,
2007, filed with the SEC on March 14, 2008, as well as other filings
by the company with the SEC.
Any forward-looking statements are made pursuant to Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, and, as such, speak only
as of the date made. Micromet, Inc. undertakes no obligation to
publicly update any forward-looking statements, whether as a result
of new information, future events or otherwise.
# # #
Contact Information
US Media: European Media:
Andrea tenBroek/Chris Stamm Ludger Wess
(781)-684-0770 +49 (40) 8816 5964
micromet@schwartz-pr.com ludger@akampion.com
US Investors: European Investors:
Susan Noonan Ines-Regina Buth
(212) 966-3650 +49 (30) 2363 2768
susan@sanoonan.com ines@akampion.com
--- Ende der Mitteilung ---
Micromet Inc.
Staffelseestr. 2 München Deutschland
WKN: A0JMQD;
ISIN: US59509C1053;
Notiert: Xetra Stars in Frankfurter Wertpapierbörse;