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Micromet Receives Regulatory Approval to Conduct a Phase 2 Clinical Trial Investigating MT103 (MEDI-538) in Patients with Acute Lymphoblastic Leukemia
Date:10/18/2007

ed as high risk and are candidates for stem cell transplantation. Optimization of treatment and reduction of relapse of patients with MRD-positive ALL represent an absolute medical need especially in patients for whom stem cell transplantation is not an option. Although CD19 is widely expressed in ALL, no antibody against this tumor associated antigen target has been developed thus far. The current clinical trial is set up to address the question of treating MRD positive ALL with a novel anti-CD19 antibody derivative," said Professor Hoelzer, Chairman of the GMALL study group.

Early observations of MT103 clinical activity were recently reported from an ongoing phase 1 clinical trial evaluating MT103 as single-agent therapy in a population of heavily pre-treated patients with NHL. These observations included complete and partial responses confirmed by independent review. In addition, MT103 not only eliminated tumor target cells in peripheral blood but also cleared lymphoma cells from heavily infiltrated bone marrow. These data were presented at the 48th Annual Meeting of the American Society for Hematology in December 2006.

"The upcoming phase 2 clinical trial in ALL is an important step to establish activity of MT103 in aggressive B cell leukemias and lymphomas," said Carsten Reinhardt, Micromet's Senior Vice President and Chief Medical Officer. "Investigating the effect of MT103 on minimal residual disease may open a highly promising new treatment concept in these diseases, that is, consolidation therapy with a BiTE antibody (MT103) after initial treatment with a chemotherapeutic regimen."

About BiTE(R) Antibodies

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. BiTE antibodies have been shown to induce an immunological synapse between a T cell and a tumor cell in the same manner as observed during physiological T cell
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SOURCE Micromet, Inc.
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