Micromet Presents Updated Data on the Phase 1 Trial Studying Blinatumomab (MT103/MEDI-538) in Patients with Advanced Non-Hodgkin
December 09 2008 - 7:00AM
PR Newswire (US)
Follow-Up Data Presented at the American Society of Hematology
(ASH) Annual Meeting Indicates that Blinatumomab is Able to Induce
Durable Remission in Patients with Relapsed NHL BETHESDA, Md., Dec.
9 /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 from its ongoing phase 1 clinical study
of BiTE(R) antibody blinatumomab (MT103/MEDI-538) in patients with
relapsed non-Hodgkin's lymphoma (NHL) at the 50th annual meeting of
the American Society of Hematology, held December 6 to 9 in San
Francisco, CA. Blinatumomab is a novel therapeutic antibody that
activates a patient's T cells to seek out and destroy cancer cells.
As previously reported, 11 of 27 patients treated at doses of 0.015
mg/m2 per day and higher have responded to treatment with
blinatumomab with partial and complete responses. The responses
were confirmed by a central laboratory using standard Cheson
criteria. Of the seven patients treated at 0.06 mg/m2 per day, all
seven have been in durable remission lasting for at least six
months and up to 14 months. Five of the seven responders continue
to be in remission. The most common adverse events (AEs) included
lymphopenia, pyrexia, and leukopenia. The vast majority of AEs
occurred early during treatment and improved or resolved during
treatment. Permanent treatment discontinuation due to AEs occurred
in a total of nine patients resulting from infections, liver enzyme
increases and fully reversible central nervous system events. "The
duration of responses seen after monotherapy of NHL patients with
blinatumomab is very encouraging and may represent a next
breakthrough in targeted therapy after the discovery of rituximab,"
said Ronald Levy, M.D., Professor of Medicine, Chief of the
Division of Oncology, at Stanford University School of Medicine.
"These follow-up data continue to demonstrate blinatumomab's
potential as a single-agent therapy for non-Hodgkin's lymphoma
patients," said Micromet's Senior Vice President and Chief Medical
Officer, Carsten Reinhardt, M.D. "The observation of durable
objective responses to the drug indicates the potential that
blinatumomab and BiTE antibodies in general may have in fighting
cancer." 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. Typically antibodies cannot engage T cells because T cells
lack the appropriate receptors for binding antibodies. Previous
attempts have shown the potential of T cells to treat cancer, but
the therapeutic approaches tested to date have been hampered by
cancer cells' ability to escape recognition by T cells. The use of
BiTE antibodies that are specifically designed to engage T cells
for attacking cancer cells may provide a more effective anti-tumor
approach than conventional monoclonal antibodies. About Micromet,
Inc. Micromet, Inc. (http://www.micromet-inc.com/) is a
biopharmaceutical company with offices in Bethesda, Maryland and
Munich, Germany. The Company is developing novel, proprietary
antibodies for the treatment of cancer, inflammation and autoimmune
diseases. The Company uses its proprietary BiTE(R) antibody
platform to create a new class of antibodies that specifically
activate T cells from the patient's own immune system to eliminate
cancer cells or other disease-related cells. Four of the Company's
antibodies are currently in clinical trials, with the remainder of
its product pipeline in preclinical development. The Company's lead
program is a BiTE antibody known as blinatumomab, or MT103. It is
in a phase 2 clinical trial for the treatment of patients with
acute lymphoblastic leukemia and a phase 1 clinical trial for the
treatment of patients with non-Hodgkin's lymphoma. Micromet is
developing blinatumomab in collaboration with MedImmune, a
subsidiary of AstraZeneca plc. Micromet's second BiTE antibody in
clinical development is MT110, which targets the epithelial cell
adhesion molecule (EpCAM). The Company owns all rights to MT 110,
which is currently in a phase 1 clinical trial for the treatment of
patients with solid tumors. The Company's third clinical stage
antibody is adecatumumab, also known as MT201, a conventional human
monoclonal antibody that targets 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. Micromet has licensed a fourth clinical
stage antibody, MT293, to TRACON Pharmaceuticals, Inc. MT293 is
being developed in a phase 1 clinical trial for the treatment of
patients with cancer. The Company's preclinical programs include
MT203, which is being developed in collaboration with Nycomed.
MT203 is a traditional human antibody neutralizing the activity of
granulocyte/macrophage colony stimulating factor (GM-CSF), which
has potential applications in the treatment of inflammatory and
autoimmune diseases, such as rheumatoid arthritis, psoriasis, or
multiple sclerosis. Additional BiTE antibodies, targeting CEA,
CD33, Her2, EGFR and MCSP, respectively, are in different stages of
preclinical development. 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 and intended utilization of our product candidates and the
development of our BiTE antibody technology. You are urged to
consider statements that include the words "may," "potential," 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, and 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. These
factors and others are more fully discussed in Micromet's Quarterly
Report on Form 10-Q for the fiscal quarter ended September 30,
2008, filed with the SEC on November 6, 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. DATASOURCE: Micromet, Inc. CONTACT: US
Media, Andrea tenBroek or 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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