A first in human proof of concept phase I clinical study of VAS-101 (Vasceptor®; topical curcumin gel) in sickle cell disease (SCD) is underway. The study is being conducted by the Foundation for Sickle Cell Disease Research (FSCDR) in Hollywood, Florida, under the supervision of the principal investigator, Dr. Gershwin Blyden.

Ten (10) patients with sickle cell disease will be treated with VAS-101 twice per week over 4 weeks for a total of 8 treatments; their blood will be drawn weekly. Five (5) patients will be treated topically on their forearm and five (5) patients will be treated sublingually (under the tongue), the duration of treatment is 29 days.

The primary study objectives are: (1) assess the safety and tolerability of VAS-101; and (2) assess its effects on impaired blood flow dynamics, including adhesion molecule expression and erythrocyte fragility parameters. The objective assessment of VAS-101 impact on red blood cell health will be performed by Functional Fluidics utilizing their proprietary assays at their specialty laboratory in Detroit, Michigan.

Secondary study objectives include (1) an evaluation of the effect of VAS-101 on inflammatory markers associated with the activation of sterile inflammation over 28 days; (2) determination of the mean change in red blood cell sickling kinetics and oxygen dissociation curves will be assessed by The Biophysical Chemistry Section, Laboratory of Chemical Physics at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in Bethesda, Maryland; and (3) assessment of the pain-relieving benefit and opioid-sparing effect of VAS-101.

Dr. Lanetta Bronté-Hall, President of FSCDR, stated, "I'm proud that we are taking part in Vascarta's pilot study, which explores a new transdermal approach to pain management for individuals living with Sickle Cell Disease (SCD). Pain remains one of the most challenging and life-disrupting aspects of this disease, and new approaches are urgently needed. While early in development, this research represents an important step toward finding new options that could one day help ease that burden. At FSCDR, we are committed to advancing care and bringing hope to the SCD community through innovation and collaboration."