CytoSorbents Corporation announced today that it was awarded a Defense Health Agency Small Business Technology Transfer (STTR) Phase III contract, valued at up to $2,897,172 over 2 years, to advance its HemoDefend-BGA plasma and whole blood adsorber to human clinical trials. The program, entitled “Development of a Highly Efficient Adsorber to Remove Anti-A and Anti-B Antibodies from Blood and Plasma for Transfusion,” is being funded by the U.S. Army Medical Research and Development Command (USAMRDC) office of the Congressionally Directed Medical Research Programs (CDMRP).
This follows the successful completion of Phase I and II STTR contracts of approximately $1.15 million with researchers at Penn State University, previously funded by the U.S. Army Medical Research Acquisition Activity (USAMRAA) and the U.S. Army Medical Research and Material Command (USAMRMC).
Plasma and whole blood are life-saving blood products, particularly in civilian and combat trauma where the loss of blood, or hemorrhage, is the leading cause of preventable deaths. However, these products have limitations due to the presence of anti-A and anti-B antibodies in the blood plasma that can cause hemolytic transfusion reactions in an incompatible recipient.
The HemoDefend-BGA filter is part of the HemoDefend™ family of blood transfusion filters, and is fundamentally different from the HemoDefend-RBC filter for packed red blood cells. The HemoDefend-BGA filter is designed to enable “universal plasma”, or plasma that can be administered to anyone regardless of blood type, and to improve the safety of whole blood transfusions, by the rapid and efficient removal of anti-A and anti-B antibodies from these two blood products. An advanced HemoDefend-BGA prototype was developed previously under the prior STTR Phase II program.
Dr. Maryann Gruda, PhD, Principal Investigator and Director of Biology of CytoSorbents stated, “We are excited to take this next major step in the development of the HemoDefend-BGA adsorber. A tremendous amount of effort and innovation has gone into the current prototype that has exceeded program performance expectations. With this new funding, we plan to optimize our prototype and scale-up manufacturing to produce commercial-grade materials. This will facilitate advancement of the HemoDefend-BGA adsorber through pre-clinical testing to human clinical trials, with the goal of potential U.S. FDA regulatory approval. If successful, we expect the HemoDefend-BGA adsorber to expand the availability of universal plasma and whole blood that may help to save warfighter and civilian lives.”
Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, “The development of a simple device that efficiently reduces the level of anti-A and anti-B antibodies in whole blood and plasma to low titer is a major milestone in our collaboration with the U.S. military. We are grateful for U.S. Army support and proud to contribute to this important program. We plan to work aggressively to make this technology commercially available as soon as possible.”
Plasma is the straw-colored, cell-free portion of whole blood. It contains a wide range of important substances such as electrolytes, hormones, proteins such as albumin, clotting factors, and antibodies. The transfusion of plasma, or plasma-derived products, is used widely to help save the lives of trauma and bleeding victims, septic and other critically-ill patients, and patients with life-threatening blood coagulation and autoimmune disorders. In 2017, approximately 3.0 million units of plasma were distributed in the United States alone. Most plasma contains blood-type specific antibodies and must be cross-matched for blood type with the intended recipient ahead of time or risk serious transfusion reactions. The only “universal” plasma is Type AB plasma, which lack anti-A and anti-B antibodies, but is rare, accounting for less than 5.0% of potential donors. By reducing these blood-type specific antibodies from donated plasma of all blood types, the goal is to create a cost-effective, reliable, and expanded source of “universal” plasma that can be administered immediately, without blood-typing, in a wide range of emergent and non-emergent situations.
Many studies have demonstrated that whole blood transfusion is superior in hemorrhage control and survival in severe trauma, compared to individual blood component transfusions (e.g. pRBCs, platelets, plasma). In the military, in emergency or mass casualty situations when the demand for refrigerated blood products has exceeded the supply inventory in the combat zone, the “Walking Blood Bank” program can be implemented, where unwounded soldiers can donate their blood to those that have fallen. Type O whole blood is typically the universal donor type, but since it is roughly 60% plasma, anti-A and anti-B antibodies can be present at various levels that can cause potentially fatal hemolytic transfusion reactions in the recipient. Currently, the military relies on pre-screening and identification of low titer Type O donors. By removing these antibodies from whole blood, HemoDefend-BGA may help to improve the safety of whole blood transfusion across all blood types and make the logistics of treatment much easier.
The HemoDefend-BGA Adsorber is not yet approved in the U.S. or elsewhere. This Award is supported by the Defense Health Agency STTR Program/U.S. Army Medical Research and Development Command (USAMRDC)/Congressionally Directed Medical Research Program (CDMRP) under Contract No. W81XWH-20-C-0050. Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the U.S. Army Medical Research and Development Command (USAMRDC) or the U.S. Army Medical Research Acquisition Activity (USAMRAA).