VAS-101 enhances the biopreservation of stored red blood cells and enables longer circulating lifespan as shown in ex vivo and in vivo studies at FDA and UC San Diego

SUMMIT, N.J., Jan. 7, 2025 /PRNewswire/ -- Stored red blood cells can undergo biochemical and structural changes called storage lesions which reduce their safety, therapeutic efficacy, and circulation lifetime when transfused. Now, scientists from the Food & Drug Administration's Laboratory of Biochemistry and Vascular Biology at the Center for Biologics Evaluation and Research, along with colleagues from the University of California San Diego and Albert Einstein College of Medicine found that these storage lesions can be mitigated by adding to stored red blood cells a highly concentrated biocompatible curcumin gel developed by Vascarta Inc. (Summit, New Jersey) for transdermal treatment of inflammation and oxidative stress.

The recently published study in Scientific Reports* shows that addition of a single dose of Vascarta transdermal curcumin gel ("VAS-101") to stored red blood cells reduces oxidative damage by about 50% and increases ATP by about 40%. ATP is crucial in allowing red blood cells to contribute to vascular homeostasis. Note: The active ingredient in VAS-101 (Vasceptor^®) is Curcugen^® (Dolcas-Biotech, Landing, NJ, USA).

Treating human red blood cells with VAS-101 increased viable red cell refrigerated storage time by one week. Moreover, when transfused into a guinea pig model, a validated surrogate for the human circulatory system, VAS-101-treated red cells survived ~10% longer than non-treated red cells.

These results suggest that VAS-101 could one day be used to improve multiple transfusion-associated properties of stored RBCs such as i) increased refrigerated storage times and ii) improved safety and efficacy, upon transfusion. Overall, these latest results augment the growing body of evidence detailing the broad therapeutic promise of VAS-101 in the field and practice of hematology, including transfusion medicine.

The authors of the publication noted, "These findings strongly suggest the utility of Vasceptor^® as a potential additive rejuvenator that could be used in the biopreservation and reversal of oxidative injury in human blood during storage."

Dr. Joel Friedman, Professor, Department of Microbiology & Immunology, Albert Einstein College of Medicine, and Scientific Founder & Chief Scientific Officer of Vascarta, Inc., stated, "These data provide mechanistic insights and supportive animal data into benefits of treating stored RBCs with a novel highly concentrated curcuminoid formulation that safely delivers curcumin to red blood cells." [Dr. Friedman is the inventor of VAS-101 which is licensed to Vascarta from the Albert Einstein College of Medicine (Bronx, New York, USA)].

Dr. Richard Prince (Vascarta CEO) stated that, "The benefits shown by Vasceptor^® in improving the health of red cells led us to prioritize human clinical testing of Vasceptor^® in sickle cell disease, which will begin in early 2025.

* https://www.nature.com/articles/s41598-024-82943-1

About the Center for Biologics Evaluation and Research (CBER)

CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

About Vascarta

Vascarta is a startup pharmaceutical company exploring efficient transdermal delivery of pharmaceuticals to address several conditions including sickle cell disease, arthritis, hypertension, aging, and cancer. More information regarding Vascarta's existing research and the opportunities to collaborate in future can be found at www.vascarta.com or by email to Vascarta's CEO, Dr. Richard Prince, at [email protected].

For residents of 22 states, Vascarta's topical, transdermal curcumin is currently available with prescription via the Town & Country Compounding Pharmacy: https://tccompound.com.

Publication Authors & Affiliations

Wayne Hicks^1,6, Sirsendu Jana^1,5,6, Tigist Kassa¹, Richard Prince², Pedro Cabrales³, Joel Friedman^2,4 & Abdu I. Alayash^1,5

¹Laboratory of Biochemistry and Vascular Biology, Center for Biologic Evaluation and Research, Food and Drug Administration, Bethesda 20993, MD, USA. ²Vascarta Inc, Summit 07901, NJ, USA. ³University of California, San Diego 92093-0412, CA, USA. ⁴Department of Microbiology and Immunology, Albert Einstein College of Medicine, NY 10461, USA. ⁵Laboratory of Biochemistry and Vascular Biology Center for Biologics Evaluation and Research Food and Drug Administration, 10903 New Hampshire Avenue Building 52/72, Room 4106, Silver Spring, MD 20993, USA. ⁶Wayne Hicks and Sirsendu Jana contributed equally to this work. email: [email protected]; [email protected]

SOURCE Vascarta Inc.