BETHESDA, Md., Aug. 3 /PRNewswire-FirstCall/ -- Micromet, Inc. (Nasdaq: MITI), a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases, today announced that it has received Orphan Drug Designation from the European Medicines Agency (EMEA) for BiTE antibody blinatumomab (MT103) for acute lymphoblastic leukemia (ALL). Blinatumomab is a novel therapeutic antibody that activates a patient's T cells to seek out and destroy cancer cells.
In June, Micromet announced that the company had achieved its primary endpoint in an ongoing Phase 2 study of ALL patients. The company presented data at the the 14(th) Congress of the European Hematology Association (EHA) in Berlin, Germany, showing an 81% response rate in acute lymphoblastic leukemia (ALL) patients with minimal residual disease (MRD)(1).
The patients included in this phase 2 clinical trial were in complete hematological remission following intense chemotherapy regimens, but 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.
According to the EMEA, "orphan" medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.
The aim of the EU legislative framework for orphan medicines is to stimulate research and development of medicinal products for rare diseases by providing incentives to the pharmaceutical industry such as simplified access to EMEA's scientific consulting resources. This initiative helps to give patients suffering from rare diseases access to the same quality of treatment as other patients.
(1) Topp, M.S. et al (2009). Blinatumomab (anti-CD19 BiTE(R)) for targeted therapy of minimal residual disease (MRD) in patients with B precursor acute lymphoblastic leukemia (ALL): Update of an ongoing Phase II study. 14th Congress of the EHA 2009, abstract no. 482
About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company developing novel, proprietary antibodies for the treatment of cancer, inflammation and autoimmune diseases. Its product development pipeline includes novel antibodies generated with its proprietary BiTE(R) antibody platform, as well as conventional monoclonal antibodies. BiTE antibodies represent a new class of antibodies that activate the T cells of a patient's immune system to eliminate cancer cells. Five of Micromet's antibodies are currently in clinical trials.
