A Phase Ib open label, randomized, safety study of SANGUINATE™ in patients with sickle cell anemia.

ABSTRACT:

Background

Treatment of sickle cell anemia is a challenging task and despite the well understood genetic and biochemical pathway of sickle hemoglobin, current therapy continues to be limited to the symptomatic treatment of pain, supplemental oxygen, antibiotics, red blood cell transfusions and hydroxyurea. SANGUINATE is a carbon monoxide releasing molecule and oxygen transfer agent under clinical development for the treatment of sickle cell anemia and comorbidities.

Methods

An open-label randomized Phase Ib study was performed in adult sickle cell anemia patients. Two dose levels of SANGUINATE were compared to hydroxyurea in 24 homozygotes for Hb SS. Twelve subjects received either a low dose (160mg/kg) of SANGUINATE or 15mg/kg hydroxyurea. Another 12 subjects received eithe

SUBMITTER: Misra H 

PROVIDER: S-EPMC5339363 | biostudies-literature | 2017 Jan - Mar

REPOSITORIES: biostudies-literature