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
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 el
|SOURCE Micromet, Inc.|
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