Ariel Pharmaceuticals, Inc. Acquires Novel Compound for Hemorrhagic Shock from the University of Minnesota
Ariel to File Investigational New Drug (IND) Application with FDA, Commence Clinical Trials in 2012
Broomfield, CO and Minneapolis, MN October 18, 2011 – Ariel Pharmaceuticals, Inc., a private, specialty pharmaceutical company focused on the development and commercialization of products for acute central nervous system (CNS) diseases and trauma, announced today that it has in-licensed Tamiasyn™ (AP-1100) for the treatment of hemorrhagic shock from the University of Minnesota.
“We are excited to have the opportunity to further develop Tamiasyn and are confident the unique neuroprotective, cytoprotective and cardioprotective attributes of this product will be more effective than the resuscitation fluids currently available,” said Steve Orndorff, President and CEO of Ariel Pharmaceuticals. “Given the dire patient need and the lack of any improvements in this field in more than 20 years, we’re dedicated to advancing Tamiasyn through commercialization as a treatment for hemorrhagic shock to provide patients with a better chance of survival.”
According to the National Center for Health Statistics, hemorrhagic shock is the leading cause of death in trauma patients worldwide, with primary causes including motor vehicle accidents (MVA) and gunshot wounds (GSW). Approximately 80,000 people die from MVA and GSW each year in the U.S. Estimates establish a global market in excess of $1 billion.
Tamiasyn is a new drug therapy in a proprietary, hypertonic formulation comprised of various therapeutic agents that readily cross the blood-brain barrier. Administered intravenously to hemorrhaging patients and having demonstrated neuroprotective and cytoprotective efficacy, Tamiasyn is a significant improvement over current therapies that only improve oxygen availability or restore blood volume.
Studies at the University of Minnesota in trauma animal models have shown that Tamiasyn stabilizes organs, including the brain; reduces oxidative stress or damage to tissues; reduces reperfusion injury and reduces the buildup of toxic levels of lactic acid while sparing energy use such as ATP.
Lester R. Drewes, Ph.D., a professor at the University of Minnesota and a biomedical scientist, explained that, “Our preclinical research has shown that Tamiasyn (AP-1100) is effective when administered after hemorrhagic shock in both small and large animal models. Therefore, Tamiasyn (AP-1100) could provide value in minimizing tissue and brain damage due to hemorrhagic shock in military combat, auto accidents or gunshot wounds where there is evidence of trauma.”
Tamiasyn has been tested for efficacy in treating small and large animals subjected to acute blood loss. The results of a small animal model of hemorrhagic shock showed that administration of Tamiasyn significantly increased survival in rats subjected to 60% blood loss as compared to controls. No significant difference in survival was found between Tamiasyn treated animals and sham operated animals that were not subjected to blood loss.
Ariel intends to file an IND application with the FDA and commence clinical trials in the second half of 2012.
About Hemorrhagic Shock
Hemorrhagic shock occurs when blood loss exceeds the body’s ability to compensate, leading to vascular collapse, inadequate vital organ perfusion, insufficient oxygenation and lack of nutrients necessary for normal cellular function. According to the National Center for Health Statistics, hemorrhagic shock is the leading cause of death in trauma patients worldwide, with primary causes including motor vehicle accidents (MVA) and gunshot wounds (GSW). Approximately 80,000 people die from MVA and GSW each year in the U.S.