Micromet Has Started a New Phase 2 Trial with Adecatumumab in Colorectal Cancer Patients
March 23 2009 - 6:00AM
PR Newswire (US)
Randomized, Controlled, Multicenter Trial Will Test Ability of
Adecatumumab to Prolong Disease Free Survival in High Risk Patients
with Liver Metastases BETHESDA, Md., March 23
/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 commencement of a randomized, controlled phase
2 trial of its human anti-EpCAM IgG1 antibody adecatumumab (MT201)
for the treatment of patients with colorectal cancer (CRC) after
complete resection of liver metastases. The trial has three arms
comparing single agent adecatumumab to combination chemotherapy
(FOLFOX: 5-FU/Leucovorin plus Oxaliplatin), and to FOLFOX followed
by adecatumumab. The primary endpoint will be the disease-free
survival rate at one year. "The relapse of colorectal cancer
patients with liver metastases still represents an area with very
high medical need" said the trial's principle investigator,
Professor Peter Neuhaus, from the Charite University Hospital in
Berlin, Germany. "Recent intensification of chemotherapeutic
regimens has shown only modest benefit and there is significant
room for improvement in these patients. EpCAM is a cancer target
which is highly expressed in colorectal cancer, and targeted
therapies such as adecatumumab could become a major breakthrough in
this setting if proven successful." Apart from being the most
highly and frequently expressed target antigen on colorectal cancer
cells, EpCAM has recently been shown to drive tumor growth and to
be expressed on colorectal cancer stem cells (1). The ability of
adecatumumab to potentially control and eliminate newly developing
metastases has been suggested in a recently reported Phase 2 trial
of adecatumumab as monotherapy in metastatic breast cancer. In this
trial, patients with high levels of EpCAM expression, in a
dose-dependent fashion, developed significantly less new lesions as
compared to patients with low levels of EpCAM (2). "Numerous
published clinical and preclinical data suggest that therapies
targeting EpCAM such as adecatumumab could prove to be highly
effective anti-cancer therapeutics," commented Carsten Reinhardt,
MD, Chief Medical Officer of Micromet. "We look forward to
exploring the promise of adecatumumab to eliminate minimal residual
disease in colorectal cancer patients and thereby to potentially
improve cure rates in these patients at high risk of relapse."
Colorectal cancer is the third most common cancer in western
countries with more than 145,000 new cases diagnosed in the US each
year. About 25 percent of patients present with liver metastases at
first diagnosis, and an additional 35 to 45 percent of patients
will develop metastases during the course of their disease. The
only chance of long-term survival comes with curative resection of
hepatic metastasis by liver surgery with reported five and 10 year
survival rates of 41 percent and 22 percent, respectively. Previous
trials of combination chemotherapy regimens in these patients have
demonstrated only very modest improvements in survival. Even
intensified treatment regimens, such as the one recently published
EORTC Intergroup trial 40983, which compared peri-operative FOLFOX
plus surgery to surgery alone, demonstrated only 7% improvement in
progression free survival at three years (3). References 1) Maetzel
D. et al., Nature Cell Biology 2009; 11: 162-171 2) Dittrich C. et
al., AACR-NCI-EORTC meeting 2007 3) Nordlinger et al., Lancet 2008;
371: 1007 About Micromet Micromet, Inc.
(http://www.micromet-inc.com/) is a biopharmaceutical company with
offices in Bethesda, MD and Munich, Germany. The Company is focused
on developing novel, proprietary antibodies for the treatment of
cancer, inflammation and autoimmune diseases. The Company's novel
antibody technology is based on its proprietary BiTE(R) antibody
platform, representing 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'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 traditional 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
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 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. Micromet
has granted an exclusive option to Bayer Schering Pharma AG to
license a BiTE antibody against an undisclosed solid tumor target.
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, safety and intended utilization of adecatumumab, . 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 Annual Report on Form 10-K for
the fiscal year ended December 31, 2008, filed with the SEC on
March 16, 2009, 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, ; US Investors: Susan Noonan,
+1-212-966-3650, ; European Media: Ludger Wess, +49 (40) 8816 5964,
; European Investors: Ines-Regina Buth, +49 (30) 2363 2768, Web
Site: http://www.micromet-inc.com/
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