Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)
Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES)
Hypereosinophilic syndrome (HES) is a rare disease with broad clinical signs and symptoms
 which is diagnosed based on a persistent blood eosinophil count of greater than 1500 cells,
 various end-organ damages (including skin, heart, lung, nervous system and digestive system
 etc.), and with exclusion of known secondary causes of hypereosinophilia.

 HES has a high morbidity/mortality rate. The major treatment of HES has been systemic
 corticosteroid and other chemotherapeutic drugs (for example, hydroxyurea and interferon)
 with the intention to lower eosinophil counts and therefore to slow down the progression of
 disease. Even though corticosteroid and other therapies can effectively reduce eosinophilia
 in some patients, some may eventually become nonresponsive and intolerable to the amount of
 side effects of the long-term therapy with these medications.

 Mepolizumab is a humanized monoclonal antibody that binds specifically to human interleukin 5
 (hIL-5) and inhibits its activity. Previous human experience has shown it has been effective
 in reducing blood eosinophilia in atopic and HES patients and has alleviated some HES
 clinical signs and symptoms. This study intends to further evaluate the
 corticosteroid-sparing and clinical benefit of mepolizumab in HES.
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Phase III Study
 to Evaluate Corticosteroid-reduction and -sparing effects of Mepolizumab 750 mg intravenously
 in Subjects with Hypereosinophilic Syndromes (HES) and to evaluate the Efficacy and Safety of
 Mepolizumab in controlling the Clinical Signs and Symptoms of HES over Nine Months
Inclusion criteria:

 -  Documented history of Hypereosinophilic Syndrome (HES)

 -  Eosinophil count greater than 1500 cells for 6 months

 -  Signs and symptoms of organ system involvement

 -  No evidence of parasitic, allergic or other causes of eosinophilia after comprehensive
 evaluation.

 -  Achieve and maintain a stable prednisone (corticosteroid) dose prior to starting study
 medication.

 -  Not pregnant or nursing.

 Exclusion criteria:

 -  Churg-Strauss Syndrome

 -  Wegener's Granulomatosis

 -  Lymphoma, hematological malignancy, advanced and metastatic solid tumors

 -  Chemotherapy, radiotherapy or interleukin 2 treatment.