Interim Phase 1 Data Presented at International Conference on Malignant
Lymphomas Shows Dose Dependent Single Agent Activity
BETHESDA, Md., June 5 /PRNewswire-FirstCall/ -- Micromet, Inc.
(Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary
antibodies for the treatment of cancer, inflammation and autoimmune diseases,
today presented an update of an ongoing phase 1 clinical trial for its BiTE(R)
antibody blinatumomab (MT103/MEDI-538) at the 10th International Conference on
Malignant Lymphomas (ICML) in Lugano, Switzerland. The new data(1) with the
CD19-specific BiTE antibody show that all seven patients in the highest dose
cohort tested so far (0.06 mg/m2/day) achieved complete or partial responses.
In the study, relapsed, incurable non-Hodgkin's lymphoma (NHL) patients
who previously failed a median of three (and up to 12) conventional therapies
were treated with increasing doses of blinatumomab (MT103/MEDI-538) for four
to eight weeks. Dose-dependent clinical activity was observed. At the recently
completed cohort of 0.06 mg/m2 per day, seven out of seven patients showed
either complete or partial responses. Remissions in this and the previous dose
cohort continue in all patients, with the longest remission ongoing for more
than one year. Most frequent side effects observed so far were lymphopenia,
pyrexia, and leukopenia. Less common adverse events included transient
neutropenia and thrombocytopenia, transient increase of liver enzymes, and
central nervous system events, all of which were fully reversible.
"The high response rate and apparently durable remissions in this heavily
pre-treated patient population support blinatumomab as a single agent therapy
with the potential for accelerated development," said Micromet's Senior Vice
President and Chief Medical Officer, Dr. Carsten Reinhardt.
"ICML brings together thousands of the world's leading specialists and
researchers to present the latest advancements and insights in the treatment
of malignant lymphomas," said Dr. Michael J. Keating, University of Texas MD
Anderson Cancer Center professor of medicine, internist for the department of
hematology, ICML advisory board member and a member of Micromet's BiTE
Antibody Scientific Advisory Board. "The data on blinatumomab show that it
holds the promise to become an effective therapy for a number of lymphomas and
leukemias."
(1) Bargou R. et al. (2008). Anti-CD19 BiTE Antibody MT103 (MEDI-538)
Induces Durable Objective Responses in Patients with Relapsed
Non-Hodgkin's Lymphoma (NHL). Update from Ongoing Phase I Study
MT103-104. ICML, Lugano, 2008.
About BiTE Antibodies
BiTE(R) antibodies are designed to direct the body's cytotoxic, or
cell-destroying, T cells against tumor cells, and represent a new therapeutic
approach to cancer therapy. BiTE antibodies have been shown to induce an
immunological synapse between a T cell and a tumor cell in the same manner as
observed during physiological T cell attacks. These cytolytic synapses enable
the delivery of cytotoxic proteins from T cells into tumor cells, ultimately
inducing a self-destruction process in the tumor cell referred to as
apoptosis, or programmed cell death. In the presence of BiTE antibodies, T
cells have been demonstrated to serially eliminate tumor cells, which explains
the activity of BiTE antibodies at very low concentrations and at very low
ratios of T cells to target cells. Through the process of killing cancer
cells, T cells proliferate, which leads to an increased number of T cells at
the site of attack.
Several antibodies in Micromet's product pipeline are BiTE antibodies and
have been generated based on Micromet's proprietary BiTE antibody platform.
The most advanced BiTE antibody is MT103 (MEDI-538), targeting CD19, and has
provided proof-of-concept in an ongoing phase 1 clinical study in patients
with advanced non-Hodgkin's lymphoma. MT110, which is targeting EpCAM (CD326)
and is the first BiTE antibody with potential applications in the treatment of
solid tumors, is in a phase 1 clinical trial in patients with lung or
gastrointestinal cancers. Two additional BiTE antibodies, targeting CD33 and
MCSP, are in preclinical development.
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(R) antibody MT103 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 MT103 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 which 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, 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.
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. 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. You are urged
to consider statements that include the words "ongoing," "may," "will,"
"would," "could," "should," "believes," "estimates," "projects," "potential,"
"expects," "suggests," "plans," "anticipates," "intends," "continues,"
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are more fully discussed in our periodic reports and other filings 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.
SOURCE Micromet, Inc.
-0- 06/05/2008
/CONTACT: US Media, Andrea tenBroek or Chris Stamm, +1-781-684-0770,
micromet@schwartz-pr.com; or European Media, Ludger Wess, +49 (40) 8816 5964,
ludger@akampion.com; or US Investors, Susan Noonan, +1-212-966-3650,
susan@sanoonan.com; or European Investors, Ines-Regina Buth,
+49 (30) 2363 2768, ines@akampion.com, all for Micromet, Inc./
/Web site: http://www.micromet-inc.com /
(MITI)
CO: Micromet, Inc.
ST: Maryland, Switzerland
IN: HEA MTC BIO
SU: TRI TDS
KF-WM
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7673 06/05/2008 07:30 EDT http://www.prnewswire.com
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