NEW ORLEANS, Dec. 7 /PRNewswire-FirstCall/ -- Micromet, Inc. , a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today announced the publication of a poster(1) with new data from its ongoing phase 1 clinical trial of its product candidate blinatumomab in patients with non-Hodgkin’s lymphoma (NHL) at the 51ST Annual Meeting of the American Society of Hematology (ASH) in New Orleans, Louisiana. Blinatumomab is a CD19-specific, T cell-engaging BiTE(R) antibody designed to direct a patient’s own T cells against cancer cells inducing a self-destruction process in cancer cells.
At the 60-microgram dose level, the most common adverse events of any grade and irrespective of drug relationship were pyrexia (100%), lymphopenia (77%), leukopenia (69%), C-reactive protein increase (62%), and headache (69%) Most adverse events occurred early during treatment and improved or resolved during treatment. The most common grade 3 and 4 adverse event was lymphopenia (77%).
“We are very excited about the high response rate seen in patients with NHL treated at the 60-microgram dose level and are now planning larger studies to confirm these encouraging results,” commented Dr. Jan Fagerberg, Micromet’s Chief Medical Officer. “We expect that the biomarker-guided dosing schedule will accelerate the clinical development of blinatumomab in all relevant B-cell lymphoma indications.”
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. 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.
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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 the efficacy, safety and intended utilization of blinatumomab, the dosing schedule designed to reduce adverse events 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.
Micromet, Inc.