Pharmaceutical company Vascarta Inc announced on Wednesday that a second proof of concept phase I clinical study of VAS-101 (Vasceptor; topical curcumin gel) in sickle cell disease (SCD) is underway.

Conducted at the National Institutes of Health (NIH) Clinical Center, the overall objective of the study is to assess the clinical safety and tolerability of a patented, bioavailability-enhanced, transdermal application of curcuminoids, VAS-101 / Vasceptor (8.5% curcuminoids transdermal gel), in individuals with stable SCD. Patients enrolled will receive 0.2 mL of VAS-101 topically twice weekly for two weeks, followed by 0.4 mL twice weekly for two weeks, then 0.6mL twice weekly for two weeks, and finally a follow-up four weeks thereafter.

Throughout the course of the study, subjects will be monitored for signs and symptoms of adverse events. The effect of VAS-101 on laboratory biomarkers of efficacy will also be studied at specific timepoints at NIH's National Heart, Lung and Blood Institute. Patients will complete the study within 14 weeks, from screening to follow-up on week 10.

Developed by Vascarta, VAS-101 is a patented topical curcumin formulation (Curcugen) that employs a patented transdermal delivery technology (Vasporta) designed to increase bioavailability.