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Selexys Pharmaceuticals Initiates SUSTAIN Phase 2 Clinical Trial in Sickle Cell Patients with Pain Crises
Date:8/19/2013

OKLAHOMA CITY, Aug. 19, 2013 /PRNewswire/ -- Selexys Pharmaceuticals Corporation, a privately held biopharmaceutical company that is developing therapies to treat inflammatory and thrombotic diseases, today announced that enrollment has been initiated in SUSTAIN, a Phase II, multicenter, randomized, placebo-controlled, double-blind, 12-month study to assess safety and efficacy of the anti-P-selectin monoclonal antibody SelG1 with or without hydroxyurea therapy in sickle cell disease patients with sickle cell-related pain crises.

The SUSTAIN trial will randomize approximately 174 patients to receive high dose SelG1, low dose SelG1 or placebo in the presence or absence of hydroxyurea therapy, the current standard of treatment. The study will examine the effectiveness of SelG1 in reducing the rate of sickle cell-related pain crises in each active dose level as compared to placebo. The study will be conducted in approximately 60 centers throughout the U.S. Further information on this trial is available at clinicaltrials.gov (NCT01895361).

"With the limited therapies available to patients with sickle cell disease, this trial with a novel P-selectin inhibitor is particularly exciting. Not only does it have the potential to improve the clinical outcomes in patients, its effects may be additive or synergistic with those of hydroxyurea, the only drug currently approved by the FDA for treatment of complications due to sickle cell disease," stated Dr. Kenneth Ataga, Lead Investigator and Associate Professor of Medicine in the Division of Hematology/Oncology, University of North Carolina at Chapel Hill.

"Data from preclinical sickle cell disease models suggest that blockade of P-selectin effectively prevents the painful stoppage of circulation in small blood vessels called vasoocclusion and maintains patent
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