NEW ORLEANS, Dec. 8 Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today announced data from its completed phase 2 clinical trial with blinatumomab in patients with B-precursor acute lymphoblastic leukemia (ALL). The data were presented in an oral presentation(1) at the 51st Annual Meeting of the American Society of Hematology (ASH) and were selected by the Society for inclusion in its "Best of ASH" session. Blinatumomab is a CD19-specific, T cell-engaging BiTE antibody designed to direct a patient's own T cells against cancer cells inducing a self-destruction process in cancer cells.
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A total of 21 patients were treated in a phase 2 clinical trial performed in collaboration with the German Multicenter Study Group on Adult Lymphoblastic Leukemia (GMALL). After having received extensive chemotherapy, all patients had ALL malignant cells persisting in their bone marrow, a disease state referred to as minimal residual disease (MRD). The primary endpoint of the clinical trial was the elimination of these cancer cells to an undetectable level in at least 22% of patients. 80% of the evaluable patients (16 of 20 patients) achieved the primary endpoint, all of them already during the first treatment cycle. The responses appear to be durable, with patients free of relapse for currently up to 15 months.
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Overall, blinatumomab was well tolerated. The most common adverse events included lymphopenia, leucopenia, pyrexia and hypoimmunoglobulinemia. One patient had to discontinue treatment due to a fully reversible neurological adverse event, and was therefore not evaluable for response assessment.
"Today, patients with MRD-positive ALL after first line therapy have a very high likelihood of relapse," commented Professor D. Hoelzer, chairman of the German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia (GMALL). "These data suggest that blinatumomab is very active and has the potential to be an effective consolidation therapy."
"The data from this completed phase 2 study confirm the high response rate reported earlier this year from the ongoing study," commented Dr. Jan Fagerberg, Micromet's Chief Medical Officer. "We expect that the positive risk/benefit profile of blinatumomab in ALL will pave the way for a pivotal trial and a fast track to market in this indication."
(1) Topp, M. et al. (2009). Report of a Phase II Trial of Single-Agent BiTE® Antibody Blinatumomab in Patients with Minimal Residual Disease (MRD) Positive B-Precursor Acute Lymphoblastic Leukemia (ALL). ASH Annual Meeting, abstract no. 840
About BiTE Antibodies
BiTE® 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. BiTE antibodies have been shown to bind T cells to tumor cells, ultimately inducing a self-destruction process in the tumor cells referred to as apoptosis, or programmed cell death. In the presence of BiTE antibodies, T cells have been demonstrated to serially eliminate tumor cells, which explains the activity of BiTE antibodies at very low concentrations. Through the killing process, T cells start to proliferate, which leads to an increased number of T cells at the site of attack.
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. Two of Micromet's BiTE antibodies and three of its conventional antibodies are currently in clinical trials. Micromet's preclinical product pipeline includes several novel BiTE antibodies generated with its proprietary BiTE antibody platform technology. Micromet's collaboration partners include sanofi-aventis, Bayer Schering Pharma, Nycomed, Merck Serono, and MedImmune.
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 blinatumomab, the mode of action of BiTE antibodies, and the conduct, timing and results of future clinical trials of blinatumomab. 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, the risks associated with the transfer and establishment of a manufacturing process for, and the manufacture of blinatumomab, and the risk of adverse outcomes of legal proceedings. These factors and others are more fully discussed in Micromet's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2009, filed with the SEC on November 6, 2009, as well as other filings by the company with the SEC.
SOURCE Micromet, Inc.
