Drug to survive blood loss closer to reality
The University of Alabama at Birmingham (UAB) will launch the first human trials of a drug that may help patients with severe bleeding survive long enough to get to appropriate medical care.
The drug, EE-3-SO4, is derived from female estrogen and is funded by the US Department of Defense (DOD).
The initial observations and subsequent research in animal models was done by Irshad H. Chaudry, Ph.D., professor in the Department of Surgery at UAB and co-principal investigator on the contract.
Chaudry and his colleagues discovered that following severe bleeding, a single injection increased survival times even in the absence of any fluid resuscitation. Time is the key. Severely hemorrhaging patients — those who experience approximately 40% or more blood loss — who do not receive fluid or blood product resuscitation within a few hours usually do not survive.
“Part of our challenge is to identify how EE-3-SO4 works its magic,” Saleh said. “We envision a single dose, injectable medication — administered in the field — which would buy time for a patient to be transported to a medical facility or advanced medical care. The key is to maintain blood flow to the brain and other important organs even while a patient is hemorrhaging.”
The drug appears to work in three ways:
• It helps the heart beat more efficiently, enabling it to fully expand and contract while pumping to maximize blood flow.
• It lowers resistance to blood flow to vital organs, and then gradually elevates blood pressure and promotes sufficient blood flow throughout the body.
• It recruits fluid from surrounding tissue, increasing blood volume to compensate for blood loss from the wound or injury. The average person has about 10 liters of this interstitial fluid in tissue and about 5 liters of blood.
The DOD contract will enable UAB to begin the first human studies of EE-3-SO4. The initial studies, or Phase 1 studies, will test the safety and tolerability of the drug in healthy humans who are not experiencing blood loss. Researchers will also use these studies to determine optimal dosing information and study the mechanism of action of this novel agent.
Secondary objectives will include determining the pharmacokinetics of the drug — to see if its effect on the heart, blood vessels and blood volume mimics that seen in non-human studies.
“There are certain relevant clinical and biologic surrogate markers that we look for, as well as predefined cardiac and vascular parameters that should give a good indication of how the drug behaves in humans,” said Saleh.
While EE-3-SO4 is promising, Saleh urges patience, as testing will be a lengthy process with no guarantee that it will prove beneficial for humans. If it does meet its potential, the drug could dramatically change how trauma care is delivered.
Category: Features, Pharmaceuticals
