About
- Vivosang Inc is an investigational stage biotechnology company formed by an early investor and former senior scientists of Sangart, Inc. (San Diego, CA) to continue development and improvement of pegylated human hemoglobin products.
- Vivosang's product is VS-101, a next generation pegylated hemoglobin based oxygen carrier, developed based on the scientific knowledge gained from decades of experience, including extensive human clinical trials of pegylated hemoglobin products.
OXYGEN TRANSPORT AND PERFUSION
VS-101
The Vivosang product platform (VS-101) is an investigational biopharmaceutical product designed to provide targeted oxygen delivery in the capillaries and enhance the perfusion of oxygen-deprived (ischemic) tissues. The starting material for VS-101 is unmodified human hemoglobin tetramers (Hb) extracted and purified from outdated human red blood cells. Polyethylene glycol (PEG) polymers are conjugated to the surface of hemoglobin amino acids, using simple and reproducible chemical reactions.
The critical design parameters of VS-101 lead to a higher oxygen-carrying capacity with targeted oxygen delivery to capillaries, especially during blood loss when the body is suffering from ischemia from constricted or obstructed blood vessels. The unique characteristics create a combined effect that prevents the premature release of oxygen in the vascular system and opens the capillary beds for perfusion and oxygen delivery. This optimizes VS-101’s therapeutic benefit for patients experiencing oxygen deprivation, by rapidly providing oxygen directly where it is needed. VS-101 can be formulated to be stored and transported at ambient temperature for rapid use during hemorrhagic resuscitation.
Unmet Medical Need
The National Trauma Institute estimated that there are over 60,000 deaths each year in the United States and 1.5 million worldwide that are attributable to shock due to blood loss from traumatic injury. The greatest opportunity to improve outcomes is resolving hemorrhagic shock as quickly as possible, making resuscitative treatment onsite and proximate to the point of injury the ideal. Whole blood and component blood products comprise the current standard for the resuscitation of hemorrhagic shock. Unfortunately, limitations of blood products, such as storage, shelf life, and incompatibility of blood types, limit their immediate availability and usefulness at treatment centers, incurring significant delays to treatment.
It has long been a goal to develop a product that could be used when blood is not available that could: 1) maintain vascular fluid volume and cardiac output, 2) provide oxygen to oxygen-deprived tissues and organs, 3) be administered without having to be typed or cross-matched to the patient’s blood. and 4) be stored and transported at room temperature.
Mission
Our mission is to provide safe and effective intravenous fluid products derived from human blood to deliver oxygen to vital organs for the treatment of traumatic hemorrhagic injury in civilian and military populations when blood is not immediately available or not a viable option.
Future goals for Vivosang's products are to develop medical applications that take advantage of the oxygen carrying capacity of the products, such as:
- Preserving organs for transplantation
- Providing hemodynamic stability during surgery
- Treating stroke or traumatic brain injury
TEAM
William Schindler JD, President, CEO
- William Schindler received his law degree from Stanford University and practiced law at Luce, Forward, Hamilton & Scripps in San Diego, California. He became an original investor in Sangart, the predecessor of Vivosang, in 1998.
- Mr Schindler brokered the investment of Leucadia National Corporation (NYSE:LUK) in Sangart in 2002. That investment increased to over $250M by 2013, as Sangart grew to over 100 employees and conducted numerous clinical trials worldwide. During this time, Mr. Schindler remained involved in the company as a minority investor.
- Mr. Schindler ultimately purchased all the intellectual property of Sangart. In the following years, he maintained the worldwide patents and prosecuted patent applications that were in the pipeline. In 2021 he founded Vivosang Inc to pursue development and commercialization of VS-101.
Kim Vandegriff PhD, Chief Science Officer
- Kim Vandegriff received her PhD in biochemistry from Rice University in the field of oxygen transport in blood and was a lecturer at Rice from 1984-86. In 1986, she began working in the Blood Research Division at the Letterman Army Research Institute in San Francisco She subsequently became an editor at Science magazine.
- In 1993, Dr. Vandegriff moved to the University of California San Diego (UCSD), where she was a co-investigator on a multidisciplinary team working in a grant program funded by the NIH to study blood substitutes. She was critically important to the theoretical and experimental implementation of an artificial capillary study and in vivo microvascular systems developed at UCSD, which confirmed the scientific basis underlying Sangart’s innovative theories of oxygen transport.
- Dr. Vandegriff has made important contributions to the understanding of the molecular mechanisms of oxygen transfer by cell-free hemoglobin, with over 50 publications in the field. She also developed a powerful method to measure hemoglobin’s oxygen binding properties.
- In 1998, she and her co-inventor on several significant hemoglobin-based oxygen transport patents left UCSD to found Sangart, Inc. Dr. Vandegriff was the co-inventor on all of the important patents that became the basis of Sangart’s technology and is a co-inventor with Ashok Malavalli on the VS-101 patents..
Ashok Malavalli MS, Chief of Operations
- Ashok Malavalli received a Bachelor and Master’s degree from Bangalore University, India.
- He has over 30 years of academic and pharmaceutical industry experience in process/pharmaceutical development, formulation, analytical method development and quality systems.
- He joined Albert Einstein College of Medicine, New York in 1994 as a research scholar and joined Sangart in 1999 to become head of manufacturing. He subsequently set up and led the quality, manufacturing, and R&D teams at Sangart.
- Mr. Malavalli is experienced in all aspects of hemoglobin chemistry, including formulation, analysis, purification and scale-up. His technical expertise includes overseeing CMO/CRO management of manufacturing process and quality systems.
- He is the co-inventor with Dr. Vandegriff on numerous patents developed at Sangart, including VS-101.
- In 2019, Mr. Malavalli founded his own company, Spectra Bio Labs, in San Diego, to provide pharmaceutical product analysis and product development services.
Preclinical Studies
2023 Military Health Systems Research Symposium, Orlando, FL
"Novel PEGylated HBOC Bridges Circulatory Function and Oxygen Delivery in Rat Exchange Transfusion."
DEVELOPMENT HISTORY
Vivosang is the scientific and intellectual successor in interest to Sangart, Inc. (San Diego, CA) founded in 1998. Clinical human trials evaluating the safety and efficacy of Sangart's product (Hemospan, later MP4OX) enrolled more than 1,400 subjects in the United States, the European Union, and worldwide between 2002 and 2013. These studies included the indication for Phase 2 clinical trials in trauma patients. These trials demonstrated the safety of MP4OX and efficacy in maintaining hemodynamic stability.
Based on these results, the FDA in September 2013, approved an escalating dose Phase 2c study of MP4OX in trauma patients in the US. This would have been the first clinical trial of an HBOC in the US since 2008, when the FDA imposed a moratorium on HBOC trials in the US.
Vivosang Inc was formed to pursue development of an improved next generation HBOC product, designated VS-101.