Data Presented at ASH Annual Meeting Indicates the Potential of T-Cell Engaging BiTE Antibody Blinatumomab as a Consolidation Tr
December 08 2008 - 6:00AM
PR Newswire (US)
Interim Data from a Phase 2 Clinical Trial in B-Precursor Acute
Lymphoblastic Leukemia Show that Blinatumomab is Able to Eliminate
Minimal Residual Disease BETHESDA, Md., Dec. 8
/PRNewswire-FirstCall/ -- Micromet, Inc. (NASDAQ: MITI), a
biopharmaceutical company developing novel, proprietary antibodies
for the treatment of cancer, inflammation and autoimmune diseases,
yesterday presented first interim data from a phase 2 clinical
trial of BiTE(R) antibody blinatumomab (MT103/MEDI-538) in patients
with acute lymphoblastic leukemia (ALL). Blinatumomab is a novel
therapeutic antibody that activates a patient's T cells to seek out
and destroy cancer cells. The presentation took place at the 50th
annual meeting of the American Society of Hematology, held December
6 to 9 in San Francisco, CA. The patients in this phase 2 clinical
trial are in complete hematological remission following intense
chemotherapy regimens, but retain ALL cancer cells in their bone
marrow - so called minimal residual disease (MRD). Various reports
have confirmed that ALL patients with MRD following chemotherapy
have a significantly worse prognosis than patients without MRD.
Interim results for the ongoing phase 2 clinical trial of
blinatumomab for ALL find the BiTE antibody was able to eliminate
MRD. Six patients have been enrolled so far in the trial. Four
patients have concluded at least two cycles of therapy with
blinatumomab. Three out of these four patients turned MRD-negative
after the first treatment cycle. One patient achieved stable
disease after the first treatment cycle and does not show signs of
hematological relapse to date. Except for one patient with a port
infection, no severe toxicities were recorded so far. "Today
patients with MRD-positive ALL after first line therapy have very
few options for treatment, and a very high likelihood of relapse,"
commented Professor D. Hoelzer, chairman of the German Multicenter
Study Group for Adult Acute Lymphoblastic Leukemia (GMALL). "The
ability to convert a patient's MRD status from positive to negative
could lead to better clinical outcomes. These data suggest that
blinatumomab may hold the potential to be an effective
consolidation therapy after prior incomplete response to
chemotherapy or even targeted therapy." "The level of response to
blinatumomab in ALL patients observed in this trial combined with
the unmet need for new therapies to treat this patient population
may open the path towards an accelerated development in this
indication," commented Micromet Senior Vice President and Chief
Medical Officer Carsten Reinhardt, M.D. Micromet will hold a
webcast and conference call on Monday, December 8 at 2:00 pm EST to
discuss this study and other blinatumomab data presented at the
conference. To access the webcast and view the PowerPoint
presentation, please log on to: http://webcasts.micromet-inc.com/.
To participate in the conference call, dial 866-700-7441 (U.S.) or
617-213-8839 (international), passcode: 39298646. 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 MT110,
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, , all for Micromet, Inc. Web Site:
http://www.micromet-inc.com/
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