Data from Phase 1 Study Confirm High Response Rate of Micromet's Blinatumomab in Patients with Non-Hodgkins Lymphoma
December 07 2009 - 7:00AM
PR Newswire (US)
NEW ORLEANS, Dec. 7 /PRNewswire-FirstCall/ -- Micromet, Inc.
(NASDAQ: MITI), a biopharmaceutical company developing novel,
proprietary antibodies for the treatment of cancer, inflammation
and autoimmune diseases, today announced the publication of a
poster(1) with new data from its ongoing phase 1 clinical trial of
its product candidate blinatumomab in patients with non-Hodgkin's
lymphoma (NHL) at the 51ST Annual Meeting of the American Society
of Hematology (ASH) in New Orleans, Louisiana. 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. The new data presented at
ASH show that 100 percent of evaluable patients (12 of 12 patients)
with relapsed/refractory NHL, who were treated with blinatumomab at
a dose level of 60 microgram/squaremeter per day, had an objective
partial or complete response after their first 4-8 weeks of
treatment. The responses were measured based on Cheson/IWG criteria
and were confirmed by independent review. One patient at the
60-microgram dose level was not evaluable because of an adverse
event that resulted in the discontinuation of treatment after two
days. The longest duration of a response without re-treatment is
currently 20 months. The response in 6 of the 12 evaluable patients
is ongoing. The 60-microgram dose level has been selected for
further clinical studies in patients with B-cell lymphoma. At the
60-microgram dose level, the most common adverse events of any
grade and irrespective of drug relationship were pyrexia (100%),
lymphopenia (77%), leukopenia (69%), C-reactive protein increase
(62%), and headache (69%) Most adverse events occurred early during
treatment and improved or resolved during treatment. The most
common grade 3 and 4 adverse event was lymphopenia (77%). At active
dose levels tested in this phase 1 clinical trial, permanent
treatment discontinuation due to adverse events resulted mainly
from fully reversible and transient neurological events during the
first few days of treatment. A low ratio of B to T cells in
peripheral blood was identified as a predictive biomarker for
neurological events in patients with NHL. Based on these findings,
and the possibility of adaptation of T cells by gradually
increasing doses of blinatumomab, Micromet has developed a
biomarker-guided dosing schedule designed to decrease the early
neurological events and to provide all patients with the
opportunity to reach the dose of 60 micrograms/squaremeter per day.
"We are very excited about the high response rate seen in patients
with NHL treated at the 60-microgram dose level and are now
planning larger studies to confirm these encouraging results,"
commented Dr. Jan Fagerberg, Micromet's Chief Medical Officer. "We
expect that the biomarker-guided dosing schedule will accelerate
the clinical development of blinatumomab in all relevant B-cell
lymphoma indications." (1) Nagorsen, D. et al. (2009) Confirmation
of Safety, Efficacy and Response Duration in Non-Hodgkin's Lymphoma
Patients Treated with 60 Microgram/Squaremeter per Day of BiTE
Antibody Blinatumomab. ASH Annual Meeting, abstract no. 2723. 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 the efficacy,
safety and intended utilization of blinatumomab, the dosing
schedule designed to reduce adverse events 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,
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