#United States #Hollywood, Florida #sickle cell disease #Vascarta #VAS-101

Vascarta Initiates Phase 1 Clinical Study for VAS-101 in Sickle Cell Disease

Vascarta Inc. has embarked on an innovative Phase 1 clinical study focusing on VAS-101, a unique topical curcumin gel designed for treating sickle cell disease (SCD). This landmark study, notable for being the first of its kind in humans, is set to take place under the Foundation for Sickle Cell Disease Research (FSCDR) in Hollywood, Florida. Led by the esteemed Dr. Gershwin Blyden, the research aims to determine the safety and effectiveness of VAS-101 in combating the challenges posed by SCD.

Study Overview

The clinical trial involves 10 patients diagnosed with sickle cell disease, who will undergo treatment with VAS-101 twice weekly for a four-week period, culminating in a total of eight applications. Participants are divided into two groups: one group receives topical treatment on their forearm, while the other group undergoes sublingual treatment (under the tongue). Blood tests will be conducted weekly to monitor various health parameters throughout the treatment phase.

The primary goals of this study focus on assessing the safety and tolerability of VAS-101 as well as its impact on blood flow dynamics within the subjects, particularly observing adhesion molecule expression and red blood cell fragility parameters. This detailed investigation into the physiological effects of the treatment is to be facilitated by Functional Fluidics at their specialized laboratory in Detroit, Michigan.

Secondary Objectives

In addition to the primary goals, the study will also analyze the influence of VAS-101 on inflammatory markers linked to sterile inflammation over a span of 28 days. Furthermore, evaluations of red blood cell sickling kinetics and oxygen dissociation curves will be conducted by The Biophysical Chemistry Section at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in Bethesda, Maryland. Pain management and the potential reduction of opioid use will also be assessed, addressing a crucial aspect of care for SCD patients.

Dr. Lanetta Bronté-Hall, President of FSCDR, expressed her pride in being part of this pioneering research effort. She highlighted the pressing need for new strategies in pain management for individuals living with SCD, given the significant pain and complications stemming from the disease. Dr. Bronté-Hall emphasized that this research marks an important stride towards offering relief and enhanced management options for SCD patients.

About VAS-101

VAS-101, developed by Vascarta, is a patented topical formulation of curcumin, aimed to enhance bioavailability through innovative transdermal delivery technology. Citing a published study in the PNAS Nexus Journal, VAS-101 has shown promise in alleviating chronic pain, improving red blood cell stability, and diminishing the inflammatory effects associated with SCD. Traditional curcumin, known for its various health benefits, has been hampered by poor bioavailability when taken orally; VAS-101 seeks to overcome this limitation.

Understanding Sickle Cell Disease

Sickle cell disease, one of the most prevalent inherited disorders, primarily affects individuals of African American and non-Hispanic Black descent in the United States. With over 165,000 cases reported in the U.S. and an estimated 45,000 in Europe, the disease is characterized by severe pain, inflammation, and a wide range of complications, including organ damage and reduced life expectancy. Current treatments often fail to adequately manage pain and come with a host of side effects, underscoring the urgent need for new therapeutic options.

Dr. Joel Friedman, a distinguished professor at Albert Einstein College of Medicine and the scientific founder of Vascarta, shared insights into the promising preclinical results highlighting pain reduction and therapeutic efficacy associated with targeting red blood cell instability and related inflammatory responses. He underlined the significance of this trial in potentially providing accessible therapies that address the multifaceted clinical challenges faced by SCD patients.

The Future of Sickle Cell Treatments

Dr. Richard Prince, Chairman and CEO of Vascarta, conveyed his excitement about VAS-101's prospects in transforming the landscape of sickle cell disease management. With limited existing therapeutic options, VAS-101 represents a potential breakthrough in improving patient outcomes and enhancing quality of life for those afflicted with this challenging condition. As the clinical study progresses, the medical community eagerly awaits the results, hoping for a new standard of care in managing sickle cell disease.

For further inquiries about Vascarta and VAS-101, please reach out to Dr. Richard Prince, or for media inquiries, connect with David Hymson using the provided contact details.