Novartis – Phase II study of crizanlizumab

New data from a post hoc analysis of the Phase II studyof crizanlizumab — a once-a-month, humanized anti-P-selectin monoclonal antibody infusion being investigated for the treatment of sickle cell disease(SCD) — shows greater reductions of vaso-occlusive crises (VOCs) in patients who were adherent to the treatment protocol. The data were presented during the 60th Annual Meeting of the American Society of Hematology (ASH) in San Diego.

Sickle cell VOCs are painful complications of the disease and the main reason why patients seek medical care in hospitals. These crises are triggered by multi-cell adhesion, or clusters of cells that blockblood flow, and are associated with increased morbidity and mortality.Currently, treatment options to prevent VOCs are limited.

‘Patients with sickle cell disease experience recurrent and severe episodes of debilitating pain that often require medical attention and emergency medical care,’ said Kenneth Ataga, MD, Director of the Center for Sickle Cell Disease at the University of Tennessee Health Science Center at Memphis, and Principal Investigator. ‘It is encouraging that these data show treatment per protocol not only reduced the frequency of painful crises, but also increased the number patients with no crises at all. These findings underscore the potential of crizanlizumab and the importance of proactive management of sickle cell disease.’

About crizanlizumab (SEG101)

Crizanlizumab (SEG101) is a humanized anti-P-selectin monoclonal antibody being investigated for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD). Crizanlizumab binds a molecule called P-selectin on the surface of endothelial cells and platelets in the blood vessels, causing a blockade of P-selectin6. P-selectin is one of the major drivers of the vaso-occlusive process. Results from the Phase II study demonstrated that crizanlizumab reduced the median annual rate of VOCs that lead to a healthcare visit compared to placebo inpatients with SCD regardless of whether or not they were taking hydroxyurea.

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