Data from Phase 1 Study Confirm High Response Rate of Micromet's Blinatumomab in Patients with Non-Hodgkins Lymphoma
NEW ORLEANS, Dec. 7 Micromet, Inc. (Nasdaq: MITI), 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 BiTEŽ antibody designed to direct a patient's own T cells against cancer cells inducing a self-destruction process in cancer cells.
The new data presented at ASH show that 100 percent of evaluable patients (12 of 12 patients) with relapsed/refractory NHL, who were treated with blinatumomab at a dose level of 60 microgram/squaremeter per day, had an objective partial or complete response after their first 4-8 weeks of treatment. The responses were measured based on Cheson/IWG criteria and were confirmed by independent review. One patient at the 60-microgram dose level was not evaluable because of an adverse event that resulted in the discontinuation of treatment after two days. The longest duration of a response without re-treatment is currently 20 months. The response in 6 of the 12 evaluable patients is ongoing. The 60-microgram dose level has been selected for further clinical studies in patients with B-cell lymphoma.
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%).
At active dose levels tested in this phase 1 clinical trial, permanent treatment discontinuation due to adverse events resulted mainly from fully reversible and transient neurological events during the first few days of treatment. A low ratio of B to T cells in peripheral blood was identified as a predictive biomarker for neurological events in patients with NHL. Based on these findings, and the possibility of adaptation of T cells by gradually increasing doses of blinatumomab, Micromet has developed a biomarker-guided dosing schedule designed to decrease the early neurological events and to provide all patients with the opportunity to reach the dose of 60 micrograms/squaremeter per day.
"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."
(1) Nagorsen, D. et al. (2009) Confirmation of Safety, Efficacy and Response Duration in Non-Hodgkin's Lymphoma Patients Treated with 60 Microgram/Squaremeter per Day of BiTE Antibody Blinatumomab. ASH Annual Meeting, abstract no. 2723.
About BiTE Antibodies
BiTEŽ 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 BiTEŽ 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.
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.
SOURCE Micromet, Inc.
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