Micromet Receives European Orphan Drug Designation for Treatment of Acute Lymphoblastic Leukemia with BiTE Antibody Blinatumomab
August 03 2009 - 8:02AM
PR Newswire (US)
BETHESDA, Md., Aug. 3 /PRNewswire-FirstCall/ -- Micromet, Inc.
(NASDAQ: MITI), a biopharmaceutical company developing novel,
proprietary antibodies for the treatment of cancer, inflammation
and autoimmune diseases, today announced that it has received
Orphan Drug Designation from the European Medicines Agency (EMEA)
for BiTE antibody blinatumomab (MT103) for acute lymphoblastic
leukemia (ALL). Blinatumomab is a novel therapeutic antibody that
activates a patient's T cells to seek out and destroy cancer cells.
In June, Micromet announced that the company had achieved its
primary endpoint in an ongoing Phase 2 study of ALL patients. The
company presented data at the the 14th Congress of the European
Hematology Association (EHA) in Berlin, Germany, showing an 81%
response rate in acute lymphoblastic leukemia (ALL) patients with
minimal residual disease (MRD)(1). The patients included in this
phase 2 clinical trial were in complete hematological remission
following intense chemotherapy regimens, but retained a detectable
level of ALL cancer cells in their bone marrow - so called minimal
residual disease (MRD). Various studies have confirmed that ALL
patients with MRD following chemotherapy have a significantly worse
prognosis than patients without MRD. According to the EMEA,
"orphan" medicinal products are intended for the diagnosis,
prevention or treatment of life-threatening or chronically
debilitating conditions that affect no more than five in 10,000
people in the European Union, or are medicines which, for economic
reasons, would be unlikely to be developed without incentives. The
aim of the EU legislative framework for orphan medicines is to
stimulate research and development of medicinal products for rare
diseases by providing incentives to the pharmaceutical industry
such as simplified access to EMEA's scientific consulting
resources. This initiative helps to give patients suffering from
rare diseases access to the same quality of treatment as other
patients. (1) Topp, M.S. et al (2009). Blinatumomab (anti-CD19 BiTE
) for targeted therapy of minimal residual disease (MRD) in
patients with B precursor acute lymphoblastic leukemia (ALL):
Update of an ongoing Phase II study. 14th Congress of the EHA 2009,
abstract no. 482 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. BiTE antibodies represent a new
class of antibodies that activate the T cells of a patient's immune
system to eliminate cancer cells. Five of Micromet's antibodies are
currently in clinical trials. Its BiTE antibody blinatumomab
(MT103) is in a phase 2 clinical trial for the treatment of
patients with acute lymphoblastic leukemia (ALL), and in a phase 1
clinical trial for the treatment of patients with non-Hodgkin's
lymphoma (NHL). A second BiTE antibody, MT110, is in a phase 1
clinical trial for the treatment of patients with solid tumors.
MT110 binds to the epithelial cell adhesion molecule, or EpCAM,
which is overexpressed in many solid tumors. Micromet's human
monoclonal antibody adecatumumab (MT201) also binds to EpCAM and is
being developed under a collaboration with Merck Serono.
Adecatumomab is in a phase 2 clinical trial in colorectal carcinoma
patients after complete resection of liver metastases, and a phase
1b clinical trial evaluating adecatumumab in combination with
docetaxel for the treatment of patients with metastatic breast
cancer. Micromet's monoclonal antibody MT293, also known as TRC093,
is licensed to TRACON Pharmaceuticals, Inc., and is in a phase 1
clinical trial for the treatment of patients with cancer. MT203, a
human antibody neutralizing the activity of granulocyte/macrophage
colony stimulating factor (GM-CSF), which has potential
applications in the treatment of various inflammatory and
autoimmune diseases, such as rheumatoid arthritis, psoriasis, or
multiple sclerosis, is in a phase 1 clinical trial conducted by
Micromet's collaboration partner Nycomed. Micromet's licensee
Morphotek, a wholly-owned subsidiary of Eisai, is also expected to
initiate a first phase 1 clinical trial with Micromet's
glycolipid-binding human antibody MT228 for the treatment of
melanoma. Micromet's preclinical product pipeline includes several
novel BiTE antibodies generated with its proprietary BiTE antibody
platform technology. A BiTE antibody targeting CEA for the
treatment of solid tumors is being developed in collaboration with
MedImmune. In addition, Micromet has entered into an option,
collaboration and license agreement with Bayer Schering Pharma AG
under which Bayer Schering Pharma was granted an exclusive option
to license a specified BiTE antibody against an undisclosed solid
tumor target. Other BiTE antibodies targeting MSCP, CD33, HER2,
EGFR and other targets are in various 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, safety and intended utilization of our 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 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 March 31, 2009, filed with the SEC on May 11,
2009, as well as other filings by the company with the SEC.
DATASOURCE: Micromet, Inc. CONTACT: US Media, Andrea tenBroek, or
Chris Stamm, +1-781-684-0770, ; or US Investors, Susan Noonan,
+1-212-966-3650, ; or European Media, Ludger Wess,
+49(40)8816-5964, ; or European Investors, Ines-Regina Buth,
+49(30)2363-2768,
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