Tag: blinatumomab

Company News: Micromet Initiates Pivotal Study of Lead Compound Blinatumomab

Micromet Inc (NASDAQ:MITI), a biotech company located in the US and in Germany, today announced the start of two Phase II trials of Blinatumomab, a so-called BiTE antibody which is designed to recruit T killer cells of the patient’s body to the cancer cells.

The so-called BLAST study (Blinatumomab Adult ALL MRD Study of T cell engagement) is designed to evaluate the efficacy, safety and tolerability of blinatumomab in up to 130 adult patients suffering from B-precursor acute lymphoblastic leukemia (ALL) who received chemotherapy but still have leukemia cells in the bone marrow (so-called minimal residual disease – MRD). About 70 centers in Europe and the US will take part in the study which will take about 2 years to complete. Primary endpoint is MRD response, i.e. disappearance of leukemia cells in the bone marrow.

If successful, the study could  serve as the basis for filing for approval.

A further Phase II study initiated today is designed to evaluate the efficacy, safety and tolerability of blinatumomab in 20 adult patients suffering from B-precursor acute lymphoblastic leukemia (ALL) who are resistant or intolerant to standard chemotherapy.

Details can be found in the press releases describing the BLAST trial and the refractory ALL trial.

Company News: Micromet Presents Updated Results From Phase 1 and Phase 2 Study of Blinatumomab

– Update Presented at the 15th Annual Congress of the European Hematology Association (EHA) –

Micromet, Inc. (NASDAQ: MITI) today announced updated clinical data from a Phase 1 and a Phase 2 trial, respectively, of its lead product blinatumomab (MT103). The data were presented at the 15th Annual Congress of the European Hematology Association (EHA) in Barcelona, Spain.

Results of the analysis from a Phase 2 trial in adult patients with minimal residual disease (MRD) positive acute lymphoblastic leukemia (ALL) demonstrate that a prolonged hematologic relapse-free survival was observed in patients treated with blinatumomab. A pivotal trial in adult MRD-positive ALL patients is scheduled to begin in Q3, 2010.

Updated results from a Phase 1 trial of blinatumomab in patients with relapsed non-Hodgkin’s lymphoma (NHL) demonstrated durable responses ranging up to 30 months. Blinatumomab is the first in a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

A conference call will be hosted tomorrow, June 15, 2010, at 08:30am ET / 02:30pm CET / 01:30pm UK time. Dial-in details and the complete announcements are available here.

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