Micromet Reports Interim Data from Phase 1 Study of BiTE Antibody MT110 for the Treatment of Solid Tumors
September 21 2009 - 9:14AM
PR Newswire (US)
BETHESDA, Md., Sept. 21 /PRNewswire-FirstCall/ -- Micromet, Inc.
(NASDAQ: MITI), a biopharmaceutical company developing novel,
proprietary antibodies for the treatment of cancer, inflammation
and autoimmune diseases, today presented first interim data from a
phase 1 dose-escalation clinical study for BiTE antibody MT110, the
first T-cell engaging antibody for the treatment of solid tumors.
The interim data(1) were presented at the Multidisciplinary
Congress of the European Cancer Organisation (ECCO) and 34th
meeting of the European Society for Medical Oncology (ESMO) in
Berlin, Germany. MT110 is designed to direct the patients' own T
cells against cancer cells that express the epithelial cell
adhesion molecule (EpCAM). To date, 20 patients with late-stage
lung or gastrointestinal cancers have been treated with MT110. The
starting dose in this phase 1 dose escalation trial was 1 g per
patient per day. Results from doses up to 12 g per patient per day
were reported. MT110 is administered by continuous intravenous
infusion for a minimum of four weeks with the option of additional
treatment cycles until disease progression. No maximum tolerated
dose has been reached and dose escalation is ongoing. MT110 is well
tolerated with no grade 3 or 4 clinical events related to MT110
therapy observed so far. The most frequent adverse events related
to MT110 treatment were mild pyrexia and fatigue. Laboratory
analysis of all patients revealed an early clinically asymptomatic
increase of liver enzymes that normalized after several days under
continued treatment. Other laboratory abnormalities included
transient lymphopenia. No cytokine release syndrome, pancreatitis
or immune response to MT110 was observed. At the dose levels tested
to date, disease stabilization was seen in 7 of 18 evaluable
patients after the first cycle of treatment, and dose escalation
continues. "We are very encouraged by the tolerability of MT110
observed in this heavily pre-treated population of cancer patients
and look forward to updating our results as we continue to increase
the dose," commented Prof. Walter Fiedler from the University
Hospital of Hamburg-Eppendorf, Germany, and principal investigator
of the study. "The interim phase 1 results and activity of MT110 at
the current dose level are what we expected based on our
preclinical data," commented Christian Itin, CEO of Micromet. "We
are now looking forward to exploring the clinical activity of MT110
at higher dose levels." MT110 is the second BiTE antibody
undergoing clinical investigation. Micromet also has ongoing trials
for blinatumomab (MT103), including a phase 2 trial for acute
lymphoblastic leukemia (ALL) and a phase 1 trial for non-Hodgkin's
lymphoma. (1) Fiedler, W. et al. (2009) Safety and pharmacology of
the EpCAM/CD3-bispecific BiTE antibody MT110 in patients with
metastatic colorectal, gastric, or lung cancer. ECCO/ESMO Meeting,
Berlin, Abstract No. 1254 About BiTE Antibodies BiTE antibodies are
the first T cell engaging antibodies to show clinical benefit in
cancer patients, representing a new approach to cancer therapy.
While previous attempts have shown the potential for the body's
cell destroying T cells to treat cancer, these therapies have been
hampered by the cancer cells' ability to avoid recognition by T
cells. BiTE antibodies engage T cells to attack cancer cells
anywhere in the body. 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 Bayer Schering Pharma, Merck Serono,
MedImmune and Nycomed. 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 safety,
efficacy, and intended utilization of Micromet's BiTE antibody
MT110 and other product candidates, the conduct, timing and results
of future clinical trials, and expectations of the future expansion
of our product pipeline and collaborations. 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
Bayer Schering Pharma, 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
Quarterly Report on Form 10-Q for the fiscal quarter ended June 30,
2009, filed with the SEC on August 6, 2009, as well as other
filings by the company with the SEC. DATASOURCE: Micromet, Inc.
CONTACT: US Media, Andrea tenBroek/Chris Stamm, +1-781-684-0770, ,
or European Media, Ludger Wess, +49(40)8816-5964, , or US
Investors, Susan Noonan, +1-212-966-3650, , or European Investors,
Ines-Regina Buth, +49(30)2363-2768, Web Site:
http://www.micromet-inc.com/
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