Tag: NASDAQ: MITI

Company News: Micromet Initiates Global Phase 2 Trial of Blinatumomab in Adult Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia

Micromet, Inc. (NASDAQ: MITI) today announced that it has initiated a phase 2 trial of its lead product candidate blinatumomab (MT103) in adult patients with relapsed or refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

This phase 2, single-arm study will evaluate the efficacy and safety of blinatumomab in approximately 65 patients with relapsed/refractory Philadelphia-negative B-precursor ALL. Patients will receive blinatumomab daily for 28 days followed by two weeks off blinatumomab over a six week treatment cycle. Patients who achieve a complete remission (CR) or complete response without full recovery of platelets (CRh*) within two cycles of treatment will receive up to three additional cycles of consolidation treatment. The primary endpoint of the study is CR/CRh*. Secondary endpoints include duration of response and overall survival. The study will be conducted at approximately 40 leading cancer centers in the U.S. and EU. The Company currently expects to complete enrollment in this trial by year end 2012.

Additional information regarding this Phase 2 study is available at the U.S. government’s clinical trials database at http://www.clinicaltrials.gov.

Blinatumomab Clinical Experience in Adult R/R ALL

Interim results from a Phase 2 trial presented at the 2011 Meeting of the European Hematology Association show that blinatumomab produced a high CR rate in adult patients with ALL who had relapsed following treatment with standard therapy. 75% of patients (9 of 12) achieved a CR or CRh* following treatment with blinatumomab1. All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival. Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh*. The most common clinical adverse events were fever, peripheral edema and fatigue. Treatment of two of the twelve patients was interrupted due to fully reversible and manageable central nervous system (CNS) events.

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.

Company News: Micromet Announces Global Collaboration with Boehringer Ingelheim for Multiple Myeloma BiTE Antibody and Reports First Quarter 2010 Financial Results

Micromet, Inc. (Nasdaq: MITI) and Boehringer Ingelheim announced today that they have entered into a collaboration agreement for the research, development and commercialization of a new BiTE antibody for the treatment of multiple myeloma.

Despite recent advances in the treatment of multiple myeloma, the disease remains largely incurable. While the majority of patients initially respond to treatment, almost all of these patients will eventually relapse.

Micromet and Boehringer Ingelheim will collaborate on the development of the BiTE antibody. Micromet is responsible for discovery of the BiTE antibody and will jointly conduct with Boehringer Ingelheim further pre-clinical studies. Boehringer Ingelheim is responsible for all manufacturing activities, clinical development and worldwide commercialization subject to Micromet’s co-promotion right in the U.S. Micromet will bear the costs up to a pre-defined amount for its preclinical activities. During commercialization Micromet will solely bear the costs for its sales force in the U.S. All other costs for research, development, manufacturing and commercialization of the BiTE antibody will be borne by Boehringer Ingelheim.

Under the terms of the agreement Boehringer Ingelheim will pay Micromet an upfront cash payment of 5 million euro (approximately $6.6 million). Micromet is eligible to receive development and regulatory milestone payments of up to 50 million euro (approximately $66 million) and tiered low double-digit royalties on product sales outside the U.S. In the U.S. Micromet and Boehringer Ingelheim will jointly co-promote the BiTE antibody with commercial terms commensurate with a profit split.

Moreover, Micromet today reported its financial results for the first quarter ended March 31, 2010. For further details, please visit Micromet´s corporate website.

Company News: Micromet Reports Fourth Quarter and Full Year 2009 Financial Results

Micromet, Inc. (NASDAQ: MITI), a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, today announced its financial results for the fourth quarter and full year ended December 31, 2009.  The Company also highlighted recent pipeline progress and outlined expected 2010 milestones.

Further details can be found at: www.micromet-inc.com