Final Data from Phase 2 Study Confirm High Response Rate of Micromet's Blinatumomab in Patients with Acute Lymphoblastic Leukemi
December 08 2009 - 10:00AM
PR Newswire (US)
- Data Were Selected for Inclusion in the American Society of
Hematology's 2009 Best of ASH Session - NEW ORLEANS, Dec. 8
/PRNewswire-FirstCall/ -- Micromet, Inc. (NASDAQ: MITI), a
biopharmaceutical company developing novel, proprietary antibodies
for the treatment of cancer, inflammation and autoimmune diseases,
today announced data from its completed phase 2 clinical trial with
blinatumomab in patients with B-precursor acute lymphoblastic
leukemia (ALL). The data were presented in an oral presentation(1)
at the 51st Annual Meeting of the American Society of Hematology
(ASH) and were selected by the Society for inclusion in its "Best
of ASH" session. Blinatumomab is a CD19-specific, T cell-engaging
BiTE antibody designed to direct a patient's own T cells against
cancer cells inducing a self-destruction process in cancer cells. A
total of 21 patients were treated in a phase 2 clinical trial
performed in collaboration with the German Multicenter Study Group
on Adult Lymphoblastic Leukemia (GMALL). After having received
extensive chemotherapy, all patients had ALL malignant cells
persisting in their bone marrow, a disease state referred to as
minimal residual disease (MRD). The primary endpoint of the
clinical trial was the elimination of these cancer cells to an
undetectable level in at least 22% of patients. 80% of the
evaluable patients (16 of 20 patients) achieved the primary
endpoint, all of them already during the first treatment cycle. The
responses appear to be durable, with patients free of relapse for
currently up to 15 months. Overall, blinatumomab was well
tolerated. The most common adverse events included lymphopenia,
leucopenia, pyrexia and hypoimmunoglobulinemia. One patient had to
discontinue treatment due to a fully reversible neurological
adverse event, and was therefore not evaluable for response
assessment. "Today, patients with MRD-positive ALL after first line
therapy have a very high likelihood of relapse," commented
Professor D. Hoelzer, chairman of the German Multicenter Study
Group for Adult Acute Lymphoblastic Leukemia (GMALL). "These data
suggest that blinatumomab is very active and has the potential to
be an effective consolidation therapy." "The data from this
completed phase 2 study confirm the high response rate reported
earlier this year from the ongoing study," commented Dr. Jan
Fagerberg, Micromet's Chief Medical Officer. "We expect that the
positive risk/benefit profile of blinatumomab in ALL will pave the
way for a pivotal trial and a fast track to market in this
indication." (1) Topp, M. et al. (2009). Report of a Phase II Trial
of Single-Agent BiTE® Antibody Blinatumomab in Patients with
Minimal Residual Disease (MRD) Positive B-Precursor Acute
Lymphoblastic Leukemia (ALL). ASH Annual Meeting, abstract no. 840
About BiTE Antibodies BiTE® 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.
Typically, antibodies cannot engage T cells because T cells lack
the appropriate receptors for binding antibodies. BiTE antibodies
have been shown to bind T cells to tumor cells, ultimately inducing
a self-destruction process in the tumor cells 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. Through the killing process, T cells start to
proliferate, which leads to an increased number of T cells at the
site of attack. About Micromet, Inc. Micromet, Inc. is a
biopharmaceutical company developing novel, proprietary antibodies
for the treatment of cancer, inflammation and autoimmune diseases.
Its product development pipeline includes novel antibodies
generated with its proprietary BiTE® antibody platform, as well as
conventional monoclonal antibodies. Two of Micromet's BiTE
antibodies and three of its conventional antibodies are currently
in clinical trials. Micromet's preclinical product pipeline
includes several novel BiTE antibodies generated with its
proprietary BiTE antibody platform technology. Micromet's
collaboration partners include sanofi-aventis, Bayer Schering
Pharma, Nycomed, Merck Serono, and MedImmune. 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
blinatumomab, the mode of action of BiTE antibodies, and the
conduct, timing and results of future clinical trials of
blinatumomab. 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, the risks associated with the transfer and
establishment of a manufacturing process for, and the manufacture
of blinatumomab, and the risk of adverse outcomes of legal
proceedings. These factors and others are more fully discussed in
Micromet's Quarterly Report on Form 10-Q for the fiscal quarter
ended September 30, 2009, filed with the SEC on November 6, 2009,
as well as other filings by the company with the SEC. DATASOURCE:
Micromet, Inc. CONTACT: US Media: Chris Stamm, +1-781-684-0770, ;
European Media: Ludger Wess, +49 (40) 8816 5964, ; US Investors:
Susan Noonan, +1-212-966-3650, ; European Investors: Ines-Regina
Buth, +49 (30) 2363 2768, Web Site: http://www.micromet-inc.com/
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