Micromet, Inc. (Nasdaq:
MITI), a biopharmaceutical company focusing on the development of novel,
proprietary antibody-based products for cancer, inflammatory and autoimmune
diseases, today reported final data from the randomized phase 2 clinical
trial of adecatumumab (MT201) in metastatic breast cancer (MBC) patients,
including recent exploratory posthoc subgroup analyses. Adecatumumab
originated at Micromet and is being developed in collaboration with Merck
Serono, a division of Merck KGaA, Darmstadt Germany. The product candidate,
a fully human monoclonal antibody targeting tumor cells overexpressing the
epithelial cell adhesion molecule (EpCAM), was tested as a single agent at
two dose levels to assess its efficacy and safety in patients with
EpCAM-positive metastatic breast cancer (N=109). EpCAM expression has been
implicated to be a negative prognostic marker associated with strongly
decreased overall survival in MBC patients.
The final data set of the Phase 2 clinical trial of adecatumumab in
patients with metastatic breast cancer including new additional subgroup
analyses was presented at the 43rd Congress of the American Society of
Clinical Oncology (ASCO) in Chicago, IL. As previously reported, the
primary endpoint of the clinical trial (i.e., 25 percent clinical benefit
rate at week 24) was not reached. However, a significant prolongation of
time-to- progression in patients treated with the higher dose of
adecatumumab compared to patients receiving the lower dose was shown
(p
"While the previously reported data of this Phase 2 clinical trial
already suggested activity of adecatumumab, this finding now is
corroborated by the results of the retrospective analyses," the principal
investigator, Dr. Ahmad Awada, Head of the Medical Oncology Clinic at
Institute Jules Bordet in Brussels, Belgium, commented. "The finding of
better clinical outcome in patients with truly high EpCAM expressing tumors
confirms the targeted nature of adecatumumab and is in line with
observations from other tumor-specific monoclonal antibodies in oncology
like Herceptin(R)."
Adecatumumab was generally well tolerated with the observation of a
dose- dependent incidence of adverse events (AE's). The most frequent AE's
were fever, chills, diarrhea, hypertension, lymphopenia and elevation of
pancreatic enzymes, and most AE's were of mild to moderate severity.
Adecatumumab is currently being explored for tolerability in
combination with docetaxel in an ongoing phase 1b clinical trial in
patients with metastatic breast cancer. An additional phase 1 clinical
trial is currently planned to investigate further increased doses of
adecatumumab and intensified dosing regimens in other EpCAM-expressing
solid tumors such as colorectal cancer, lung cancer, gastric cancer, and
ovarian cancer.
About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company focusing on the
development of novel, proprietary antibody-based products for cancer,
inflammatory and autoimmune diseases. Two product candidates are currently
in clinical trials. MT103/MEDI-538, which is the first product candidate
based on Micromet's novel BiTE(R) product development platform, is being
evaluated in a phase 1 clinical trial for the treatment of patients with
non-Hodgkin's lymphoma. The BiTE product development platform is based on a
unique, antibody-based format that leverages the cytotoxic potential of T
cells, widely recognized as the most powerful 'killer cells' of the human
immune system. Adecatumumab (MT201), a recombinant human monoclonal
antibody which targets EpCAM expressing tumors, has completed two phase 2a
clinical trials, one in patients with breast cancer and the other in
patients with prostate cancer. In addition, a phase 1b trial evaluating the
safety and tolerability of MT201 in combination with docetaxel is currently
ongoing in patients with metastatic breast cancer. Micromet has established
collaborations with MedImmune, Inc. for MT103/MEDI-538 and Merck Serono for
adecatumumab (MT201).
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. Such forward-looking statements
include statements regarding the company's clinical development activities;
the observation of clinical activity of MT201 in metastatic breast cancer;
the potential for such clinical activity to be confirmed in additional
clinical trials; the potential for adecatumumab to offer a treatment option
for patients with high EpCAM overexpression; Micromet's and Merck Serono's
intention to continue the development of adecatumumab for the treatment of
metastatic breast cancer in combination with docetaxel; the evaluation of
other solid tumor settings for additional development opportunities;
Micromet's and Merck Serono's intention to continue to explore the future
development opportunities; and plans regarding regulatory filings. Factors
that may cause actual results to differ materially include the risk that
product candidates that appeared promising in early research and clinical
trials do not demonstrate safety and/or efficacy in larger-scale or later
clinical trials, the risk that encouraging results from clinical trials may
not be confirmed upon further analysis of the detailed results of a
clinical trial and additional information relating to the safety, efficacy
or tolerability of our product candidates may be discovered upon further
analysis of the clinical trial data, the risk that we 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 collaborative partners, including Merck Serono,
for further clinical trials, development and commercialization of product
candidates, including MT201. You are urged to consider statements that
include the words "ongoing", "may", "will", "would", "could", "should",
"believes", "estimates", "projects", "potential", "expects", "suggests",
"plans", "anticipates", "intends", "continues", "forecast", "designed",
"goal", or the negative of those words or other comparable words to be
uncertain and forward-looking. These factors and others are more fully
discussed in our periodic reports and other filings 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.
Micromet, Inc.
micromet-inc
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