Micromet's Favorable Trial Results

Positive interim data from phase 2 clinical trials of lead drug candidate MT103

Micromet, Inc. (MITI - Analyst Report) announced yesterday that the German Multicenter ALL Study Group presented phase 2 clinical data of lead drug candidate BiTE antibody blinatumomab (MT103) at the 14th Congress of the European Hematology Association held recently in Berlin, Germany, showing a high response rate in acute lymphoblastic leukemia (ALL) patients with minimal residual disease (MRD).

The patients included in this phase 2 clinical trial were in complete hematological remission following intense chemotherapy regimens, but had retained a detectable level of ALL cancer cells in their bone marrow, so called minimal residual disease (MRD). Various studies have confirmed that ALL patients with MRD following chemotherapy have a significantly worse prognosis than patients without MRD.

The ALL interim data showed an MRD response rate above 80%, which significantly exceeded the rate which was considered to be clinically meaningful and was set as the hurdle for the achievement of the primary endpoint. With 13 of 16, or 81% of evaluated patients having shown an MRD response, the trial met its primary endpoint. The most common adverse events included lymphopenia, pyrexia and leukopenia.

Recently MITI indicated that a rapid path to market had been identified in ALL for MT103, with a registration trial planned for 2010. We view yesterday's news as positive for the stock and are currently reviewing our Hold recommendation.