US-based Prolong Pharmaceuticals has concluded enrolling patients in a Phase II trial to examine Sanguinate for treatment of vaso-occlusive crisis (VOC) in patients with sickle cell disease (SCD).
VOC is a complication of sickle cell disease that causes severe pain.
The trial is entitled ‘A Phase II, Multicenter, Single-Blind, Randomised Study of the Safety and Effectiveness of SANGUINATE Versus Normal Saline in Adult Sickle Cell Disease Patients With Vaso-Occlusive Crisis (VOC)’.
It aims to evaluate the safety and efficacy of Sanguinate for the treatment of VOC and expects to provide data by the first half of next year.
Earlier this week, Prolong presented preliminary results from a subset of patients. The results included an exploratory assessment of patient samples for the ‘un-sickling’ effect on red blood cells (RBCs) and its association with pain score after treating with Sanguinate.
Prolong Pharmaceuticals Research and Development vice-president Ronald Jubin said: “The potential for restoration of normal RBC shape is important because VOC occurs when sickle-shaped RBCs, the hallmark of SCD, block blood vessels and restrict blood flow, thereby depriving body tissues and organs of oxygen.
“This complication can damage the tissues and organs, causing severe pain.
“The data interpretation presented at ASH is preliminary, and the full data set from the Phase II trial of Sanguinate remains to be analysed.”
Separately, Prolong presented data from a novel rat model of acute VOC, where Sanguinate promoted VOC resolution by improving blood flow and restoring tissue oxygenation to near-baseline levels.