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Soliris Effective in PNH Patients With History of Aplastic Anemia,and Myelodysplastic Syndromes

al Sloan-Kettering Cancer Center. "The EXPLORE study will help hematologists-oncologists better understand the prevalence and clinical characteristics of PNH in patients with bone marrow disorders. Many of these patients may benefit from treatment with Soliris. Data from EXPLORE may also help us define and implement screening protocols for PNH."

PNH is a rare, disabling and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Hemolysis can cause one or more of the following symptoms in patients with PNH: severe anemia, disabling fatigue, recurrent pain, shortness of breath, pulmonary hypertension, intermittent episodes of dark colored urine (hemoglobinuria), kidney disease, impaired quality of life and blood clots (thromboses).(1)(2)

PNH has been identified more commonly among patients with disorders of the bone marrow, including AA and MDS.(3)(4)(5)(6) Underlying bone marrow dysfunction can complicate the clinical course of PNH, contributing to anemia, a greater dependence on transfusion support, an increased risk of infection and life-threatening hemorrhage.(7) AA occurs when the bone marrow stops making enough blood-forming stem cells. MDS occurs when the bone marrow and stem cells malfunction, resulting in the production of too many defective blood cells and not enough normal blood cells.

Data Presented at ASCO

Researchers conducted an analysis of data from the Phase III TRIUMPH and SHEPHERD clinical trials to evaluate the safety and efficacy of Soliris treatment over 26 weeks in 39 patients who were diagnosed with PNH and who had a history of AA or MDS. Among these patients, hemolysis was reduced by 84 percent, compared with an 85 percent reduction among patients without a history of AA or MDS. Anemia was also significantly reduced in these patients, as transfusions of packed red blood cells (RBCs) were reduced from a median of seven units/patient prior to treatment to zero units/patient while
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