The recombinant anti-CD20 monoclonal antibody (LFB-R603) produced by LFB Biotechnologies, a leading European biopharmaceutical company, received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL). This approval from the FDA Office of Orphan Products Development was granted on August 6th, 2010.

Chronic lymphocytic leukemia is the most common form of leukemia in the United States. It is estimated that 108,437 persons in the USA are living with or are in remission from CLL. Though its cause remains unknown, it is characterized by the proliferation of B lymphocytes that migrate into the lymph nodes, spleen and liver and invade the bone marrow and blood. This can lead to anemia and/or thrombocytopenia (drop in platelet count) and induces an immunocompromised state in patients, thus increasing the risk of severe infections. Chronic lymphocytic leukemia is rare in patients under 55 years (only 11%) and incidence rises rapidly with age above 55 years. The median age at diagnosis is 72 years. Median survival is about 10 years but varies from less than 3 years to a normal life expectancy depending on prognostic factors.

At present, there is no true curative approach in the vast majority of patients with CLL.

LFB-R603 is a chimeric recombinant monoclonal antibody directed towards the CD20 antigen expressed on the surface of B cells. The specific glycosylation profile of LFB-R603 gives it powerful ADCC (antibody-dependent cell-mediated cytotoxicity) activity directed against the tumor cells carrying this antigen. This exceptional high cytotoxicity has been demonstrated in non clinical studies performed in vitro and in vivo experimental models. LFB-R603 could be more effective than the reference anti-CD20 antibody, and thus constitute a major breakthrough in the treatment of Chronic Lymphocytic Leukemia. LFB-R603 is currently under study in a phase I/II clinical trial in Europe for this indication. LFB?s recombinant anti-CD20 received orphan drug status for the treatment of CLL in Europe in October 2009.

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