Alexion Secures U.S. Patent for ALXN6000, a First-In-Class Anti-CD200 Monoclonal Antibody
"Alexion continues to be focused on developing first-in-class therapeuticsfor patients who have severe and life-threatening medical conditions, and few,if any, treatment options," said Leonard Bell, M.D., Chief Executive Officerof Alexion. "We are committed to fully investigate the therapeutic potentialof ALXN6000 as a drug therapy for patients with B-cell chronic lymphocyticleukemia and other hematologic and solid-tumor cancers."
The U.S. Food and Drug Administration ("FDA") recently authorizedAlexion's Investigational New Drug application ("IND") for a clinical trial ofALXN6000 as a treatment for patients with refractory or relapsing B-cellChronic Lymphocytic Leukemia ("CLL"). As previously announced, dosing in anopen-label Phase I/II trial has commenced. Recruitment and dosing of patientsin the trial is expected to continue through 2009. More information isavailable at the www.clinicaltrials.gov website maintained by the U.S.National Institutes of Health.
The CD200 molecule is overexpressed in certain tumor cells and may inhibitthe body's immune response to that tumor which could allow for the growth andsurvival of tumors involved in several types of cancers, including CLL,multiple myeloma, non-Hodgkins lymphoma, melanoma, ovarian cancer andneuroblastoma. Laboratory data have shown that ALXN6000 blocks binding ofCD200 to the CD200 receptor, which has been shown to enhance the immuneresponse to tumors and reduce tumor growth. The anti-tumor activity ofALXN6000 was reported in the January 2008 issue of the Journal of Immunology.(1)
CLL is the second most common type of leukemia in adults. (2) The AmericanCancer Society estimates that, in 2008, there will be approximately 15,000 newcases of CLL in the United States. Approximately 4,000 people in this countryare expected to die of CLL during 2008. (3) CLL, which involves production ofabnormal lymphocytes (white blood cells) starts in the bone marrow and canspread through the blood to the lymph nodes, spleen, liver and other parts ofthe body. (3) B-cell CLL is characterized by clonal expansion of abnormal Blymphocytes. Patients with CLL also may develop enlargement of the spleen andlymph nodes, and pancytopenia (depletion of red and white blood cells andplatelets), ultimately resulting in hemorrhage, infection and death. (4)
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working todevelop and deliver life-changing drug therapies for patients with serious andlife-threatening medical conditions. Alexion is engaged in the discovery,development and commercialization of therapeutic products aimed at treatingpatients with a wide array of severe disease states, including hematologicdiseases, cancer, and autoimmune disorders. In March 2007, the FDA grantedmarketing approval for Alexion's first product, Soliris(R) (eculizumab), forall patients with paroxysmal nocturnal hemoglobinuria ("PNH"), a rare,debilitating and life-threatening blood disease. In June 2007, the EuropeanCommission granted marketing approval for Soliris in the European Union forall patients with PNH. Alexion is evaluating other potential indications forSoliris as well as other formulations of eculizumab for additional clinicalindications, and is pursuing development of other antibody product candidatesin early stages of development. This press release and further informationabout
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