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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

BETHESDA, Md., Feb. 10 /PRNewswire-FirstCall/ -- At its annual investor R&D Day today, Micromet, Inc. (Nasdaq: MITI) outlined the design of a registration study for the Company's lead product candidate blinatumomab in acute lymphocytic leukemia (ALL), highlighted clinical data demonstrating the breadth of blinatumomab's activity in B-cell non-Hodgkin's lymphomas and announced plans to expand clinical development of blinatumomab in the U.S.

"We are very pleased with the strong support received from the medical community for the planned pivotal study in adult ALL," said Christian Itin, Ph.D., Micromet's President and Chief Executive Officer. "Based on our discussions with the EMEA on the study design, we plan to initiate patient enrollment in the EU in mid-2010."  

Blinatumomab Development Program Highlights

Micromet provided additional details today on its plans to expand development of blinatumomab in leukemia:

  • EU pivotal study of blinatumomab in MRD-positive adult ALL – The Company plans to initiate a pivotal, single-arm study that will seek to enroll approximately 130 adult patients with MRD-positive ALL. Patients will receive up to four 4-week treatment cycles of blinatumomab at a dose of 15 micrograms/m2/day.  Key endpoints of the study include molecular complete response (MRD negativity) and relapse-free survival rate.  The Company currently anticipates enrolling patients in both the EU and US.  The Company plans to discuss its registration strategy for blinatumomab in the U.S. with the FDA later this year.

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SOURCE Micromet, Inc.
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