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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

BETHESDA, Md., Oct. 18 /PRNewswire-FirstCall/ -- Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company focusing on the development of novel, proprietary antibody-based products for the treatment of cancer, inflammatory and autoimmune diseases, announced today that the Paul-Ehrlich Institute has approved an Investigational Medicinal Product Dossier (IMPD) for the conduct of a phase 2 clinical trial testing MT103 in patients with acute lymphoblastic leukemia (ALL) in Germany. MT103, a BiTE(R) antibody targeting the CD19 antigen, which is expressed on most malignant B lymphoma cells, is also being evaluated in an ongoing phase 1 clinical trial in Europe in non- Hodgkin's lymphoma (NHL). Micromet and MedImmune, a subsidiary of AstraZeneca plc, are currently developing MT103 (also known as MEDI-538). Under a 2003 agreement, Micromet granted MedImmune exclusive rights for MT103 for North America.

Acute lymphoblastic leukemia is a highly aggressive form of B-cell leukemia. Currently, patients are initially treated with complex and toxic chemotherapy regimens that can be followed by bone marrow stem cell transplantation. If patients have low amounts of residual tumor cells after chemotherapy (also known as "minimal residual disease" or MRD) they are at a very high risk of relapse. This phase 2 clinical trial will test whether MT103 can remove residual tumor cells and thereby convert patients from a MRD- positive to a MRD-negative status with an improved time to relapse.

"When MRD is detectable, the median relapse free survival in patients is only 4.1 months. In the German Multicenter Study Group for Adult ALL (GMALL) studies, patients with MRD after induction and the first consolidation treatment are identifi
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SOURCE Micromet, Inc.
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