Technology developed nearly two decades ago with the goal of allowing U.S. Navy submarines to remain submerged for longer periods of time might be making some waves here on land within the next few years.
New Health Sciences has been quietly developing a system based on work done at Los Alamos National Laboratory to improve the quality of transfused blood and potentially extend its shelf life by storing it anaerobically after donation.
Under today’s FDA guidelines, donated blood can be stored for up to six weeks before it’s given to a patient in need. The thing is, researchers have actually known for a while now that blood begins to deteriorate even before that six-week mark, said New Health Sciences CEO Martin Cannon.
For example, a recent meta-analysis of 21 studies comparing outcomes in people who received older versus fresher blood found older blood to be associated with a higher risk of death.
The Los Alamos researchers hypothesized that some of that deterioration resulted from oxidative stress that red blood cells experienced as they were exposed to oxygen throughout the collection and storage process.
“A great deal of good is done in conventional storage, and also by the improvements that have been made over time in storage solutions, but they don’t deal with the oxidative damage,” Cannon explained.
New Health Sciences believes that if it can minimize oxidative damage to red blood cells, patients would be able to receive safer and more efficacious blood transfusions, potentially even beyond blood’s supposed six-week shelf life. It’s developing Hemanext, a system that’s designed to interface with traditional methods of collecting and storing blood.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
After blood is collected from a donor, it’s separated into transfusable components — plasma, platelets and red cells. Hemanext concerns itself only with the red cells, which are run through a device that removes nearly all of the oxygen from them, Cannon said. There are several ways a device could do this, and the company is still ironing out which mechanism would be optimal in terms of safety to the cells, cost and workflow for the blood banks.
Once they’ve been deoxygenized, the cells go into an anaerobic storage bag, which Cannon said is similar to a traditional storage bag but has the added property of keeping oxygen out of the blood. When it’s ready to be used, a clinician can either reoxygenate the blood or just deliver it to the patient, where it will be reoxygenated almost instantaneously when it goes into the body, Cannon said.
NIH-funded studies of Hemanext have repeatedly shown improvements versus conventional storage in red blood cells’ 24-hour post-transfusion survival and hemolysis, as well as in several other measures of red blood cell health, Cannon said. The company ultimately hopes to demonstrate that blood stored for three to six weeks using Hemanext closely resembles blood stored conventionally for two weeks or less.
The next step for New Health Sciences is to decide on what the exact version of the commercial product will look like, which Cannon expects to happen before the end of the year. “We think early 2015 for a European trial with a U.S. study to follow in late ’15 or ’16,” he said, adding that the company will seek approval for extended storage of blood.
The Bethesda, Md., company is financed with a little over $20 million in NIH grants and “repeated investment of high-net worth ‘family offices,'” Cannon added.
New Health Sciences acquired the technology from an investment fund that had originally licensed it from Los Alamos National Laboratory. Cannon had advised that fund on the transaction and helped develop a business plan. When it became clear that the fund had lost the ability and desire to develop it, he scooped it up and began a real push to develop and commercialize it in 2009.
“What we’re truly in the business of doing is generating a free supply of much fresher cells through altering the way red blood cells are managed in the blood bank,” he said.
[Image credit: New Health Sciences, BigStock Photos]
