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Micromet Highlights Clinical Plans and Regulatory Strategy for Lead Product Candidate Blinatumomab at its Annual R&D Day
Date:2/10/2010

atumomab in pediatric ALL – Based on experience from compassionate use utilization of blinatumomab in pediatric patients with relapsed/refractory ALL, the efficacy results in adult ALL and preliminary discussions with the EMEA, the Company is in the process of designing studies to facilitate expedited development of blinatumomab in this setting. The Company expects to finalize discussions with FDA and EMEA regarding its registration strategy in pediatric ALL during the course of 2010.

"Children resistant to available treatments for ALL are in dire need of new therapeutic options," said Arend von Stackelberg, M.D., Pediatric Oncology/Hemotology, Charite - University Clinic, Berlin, Germany.  "The experience to date with blinatumomab in ALL is very encouraging and provides a strong rationale for expanded development in the pediatric setting."

  • Phase 2 study in relapsed/refractory adult ALL – The Company plans to initiate an exploratory Phase 2 single-arm study in adult patients with relapsed/refractory ALL.  The primary endpoint of the study is hematological complete response rate.  The Company currently expects to initiate the study in mid-2010.

"Many adults with ALL who achieve complete remission will eventually relapse, making prevention of recurrence the best strategy for long-term patient survival," said Deborah Thomas, M.D., Associate Professor, Department of Leukemia, MD Anderson Cancer Center, Houston, Texas.  "Novel therapeutic approaches for the treatment of this disease are therefore desperately needed."

  • Phase 2 study in relapsed/refractory Chronic Lymphocytic Leukemia (CLL) – In collaboration with leading investigator
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SOURCE Micromet, Inc.
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