S-G04

With U.S. Blood Donations at a 20-Year Low, New Research Published in the Journal Blood Demonstrates How the Additive Could Extend Platelet Storage to 14 Days, Significantly Reducing Contamination Risk and Waste CINCINNATI, Aug. 21, 2024 /PRNewswire/ -- Preservation Bio, a leader in platelet preservation technology, today announced a major advancement in transfusion medicine, validated by a pivotal study published in the prestigious journal Blood. The research, led by Preservation Bio's scientific co-founders, Dr. Jose Cancelas and Dr. Yi Zheng, introduces an innovative ex vivo platelet additive that could revolutionize blood banking by enabling long-term cold storage of platelets. The United States is facing a severe crisis in the blood supply chain, with the American Red Cross reporting the lowest number of blood donors in 20 years. This blood shortage has significant implications, particularly for platelet supplies, which are essential for many life-saving medical procedures. Preservation Bio's innovative ex vivo platelet additive addresses this critical blood supply challenge by enabling the long-term cold storage of platelets for up to 14 days. This breakthrough in refrigeration offers several key advantages, including the potential to extend platelet shelf life well beyond the current 5-7 days, thereby reducing seasonal and regional fluctuations in platelet supply and minimizing waste. "Our innovation represents a promising advancement in platelet storage that could address some of the most pressing challenges in transfusion medicine," said Dr. Jose Cancelas, scientific co-founder of Preservation Bio. "By extending platelet shelf life and reducing the risk of contamination, our additive aims to enhance patient safety and ensure that every donation has the maximum impact, especially at a time when the blood supply is critically low. While we are still in the early stages of development, we are hopeful that this additive could pave the way for a more reliable global platelet supply." By significantly enhancing storage quality and safety with refrigeration, Preservation Bio's ex vivo platelet additive reduces the risk of bacterial contamination associated with traditional room temperature storage methods. The additive is versatile enough to support the production of long-term stored platelets across various platforms, ensuring they are suitable for transfusion in all patient groups. This flexibility allows blood centers and hospitals to maintain a unified inventory that can serve both trauma patients and those with hematologic conditions, simplifying logistics and improving resource allocation. These advancements could play a crucial role in stabilizing the platelet supply and easing the burden of declining donation rates. "Our ex vivo additive not only protects platelets from cold lesions but also induces a 'reversible hibernated' state, preserving their functionality after extended cold storage," said Dr. Yi Zheng, an expert in RHOA biochemistry and scientific co-founder at Preservation Bio. "This additive has the potential to fundamentally change how we approach platelet storage and transfusions in the future." The study in Blood, titled "Inhibition of RHOA Activity Preserves the Survival and Hemostasis Function of Long-Term Cold Stored Platelets," presents these key findings: RHOA GTPase Activation Identified: The study identified RHOA GTPase activation as a key molecular switch controlling cold platelet storage lesions. Development of RHoA Inhibitors: RHOA chiral enantiomer inhibitors (R-G04 and S-G04) were developed to effectively prevent cold storage-induced damage. Prolonged Survival and Function: Cold-stored platelets treated with these inhibitors for up to 14 days maintained survival and hemostatic function comparable to 5-7 days for room temperature stored platelets. Prevention of Cold Damage: The inhibitors act by blocking the key regulator of cold-induced damage, preventing multiple biochemical, structural and functional problems of cold-stored platelets resulting in platelet clearance and hemostatic dysfunction. Prevention of Bacterial Growth: The inhibitors will prevent bacterial growth and allow cold storage of platelets amenable to be transfused to essentially all patients in need including immunodeficient cancer patients. Potential for Clinical Application: The inhibitors preserved clotting activity of human platelets transfused and corrected the excess bleeding in animals with reduced platelet count and/or deficient activity, supporting an application for clinical transfusion. Dr. Pampee Young, Chief Medical Officer of Biomedical Services at the American Red Cross, added, "This groundbreaking advancement in platelet storage technology is set to revolutionize care for cancer and trauma patients. Traditionally, cold-stored platelets, known for their superior ability to stop bleeding, have been quickly cleared from the body, limiting their clinical use. But now, Preservation Bio's cutting-edge approach that inhibits RHOA activity has been shown to preserve the function and extend the lifespan of these platelets, making them viable for longer and safer use. This innovation represents a transformative advancement in transfusion medicine, and can address critical challenges in both the availability and safety of platelet transfusions." "We are excited to move this research closer to becoming a commercial product that could significantly help patients requiring platelet transfusions," said Rich Ganz, CEO of Preservation Bio and Senior Venture Partner at Orange Grove Bio. "By enhancing the safety and availability of platelets, our goal is to support healthcare providers and improve patient outcomes, particularly as we face ongoing challenges with declining blood donations." Preservation Bio is preparing to file an IND and initiate a Phase 1 clinical trial at the Hoxworth Blood Center in Cincinnati and the American Red Cross in Virginia. The key endpoints will be platelet survival and recovery. Following successful Phase 1 results, Preservation Bio plans to conduct a pivotal trial at major cancer centers in the United States. About Preservation Bio Preservation Bio, a subsidiary of Orange Grove Bio, is pioneering advancements in transfusion medicine with its innovative ex vivo platelet additive. This platelet preservation technology has the potential to extend platelet shelf life to 14 days under refrigeration, addressing critical challenges in the blood supply chain amid a national donation crisis. By significantly reducing contamination risks and enhancing platelet availability, Preservation Bio aims to revolutionize blood banking and improve patient outcomes. For more information about Preservation Bio and its platelet preservation technology, please visit . Media Contact: Chris Hempel Spark Public Relations [email protected] SOURCE Preservation Bio