Device aims to save lives, reduce costs in the ICU

For a doctor trying to explain complex jargon to a simple journalist, Phillip Chan is especially astute at using plain words.

A graduate of the Yale School of Medicine, Chan is the CEO of publicly-traded CytoSorbents Corp., a critical-care immunotherapy company that’s using blood purification to treat life-threatening illnesses in the intensive care unit (ICU). The company’s flagship product is the CytoSorb, a blood-filtration cartridge composed of highly-porous polymer beads, each roughly the size of a grain of salt, that act like tiny sponges to remove inflammatory cytokines and bacterial toxins from blood.

Cytokines are small proteins that normally help stimulate and regulate the immune response and are necessary for the immune system to function properly and protect us from injury and infection, Chan says. However, when a patient suffers a life-threatening illness, such as major trauma, sepsis, or burn injury, the immune system produces high levels of cytokines that can become dangerous, creating something called a cytokine storm.

This storm can lead to severe inflammation throughout the body, which can then lead to widespread cell damage, organ failure, or death. Chan says organ failures account for nearly half of all ICU deaths with no effective therapy currently available to prevent or treat it.

This is where CytoSorbents’ technology comes in. CytoSorb’s goal is to reduce cytokines and other substances that fuel the fire of inflammation. The porous polymer bead’s extraction technology removes inflammatory toxins based on size as well as surface adsorption, Chan says.

“There are more than a hundred different cytokines produced by the body, but they all turn out to be in a very specific molecular size range,” he explains. “We have specifically optimized CytoSorb to target this cytokine sweet spot. Things like blood cells are too big to get into the pores, so they end up going around the beads. Very small things like blood chemistries, electrolytes, and other things go through beads. But appropriately sized molecules get trapped in the vast porous network of each bead and permanently eliminated from blood.”

Chan says the beads can be used in different ways, but the major configuration is to pack these beads into a hemoperfusion cartridge. Hemoperfusion is one of the three major forms of blood purification, next to hemodialysis, and hemofiltration. Then, like in kidney dialysis, blood is taken outside of the body, passed through a standard hemodialysis machine, and pumped through the cartridge. Full of CytoSorb beads, the cartridge filters out the toxic materials. After that, the purified blood is pumped back into the body.

I told Chan the process sounded complicated. Just the opposite, he responded.

“This is even easier to use than dialysis. It uses the same machine, but it’s much simpler to set up,” he explains. “It’s really just blood in, blood out. Sometimes we call it a Brita filter for your blood. You just recirculate the patient’s blood over and over again through the cartridge. In a six hour period, we can treat a patient’s total blood volume 20 to 30 times.”

CytoSorb is the only specifically approved cytokine filter in the European Union (E.U.) for use in any situation where cytokines are elevated. It is currently being marketed throughout the E.U., India, the Middle East, Turkey, and Russia.
 

Government and military support

CytoSorbents is currently part of the Defense Department’s consortium to treat sepsis – one of the leading causes of death among military members in battlefield treatment.

Sepsis, according to the National Institute of General Medical Science (NIGMS), is an intense immune response to infection that can lead to organ failure and death.

Funded through the department’s Defense Advanced Research Projects Agency (DARPA), the Dialysis-Like Therapeutics (DLT) program includes groups such as Battelle Laboratories, Harvard’s Wyss Institute, Nx Stage Medical, and the Massachusetts Institute of Technology (MIT). The program’s goal is “to develop a portable device that removes ‘dirty’ blood from the body, separates harmful agents, and returns ‘clean’ blood to the body in a manner similar to a dialysis treatment of kidney failure.” In essence, says Chan, this is a blood-purification device that could save thousands of lives and billions of dollars per year in the United States and elsewhere.

Chan says CytoSorbents has a $3.8 million, 5-year contract with the DLT program to develop its CytoSorb technology to remove bacterial and bio-warfare toxins from the blood in addition to cytokines.

CytoSorbents is also working with the U.S. Army’s Institute of Surgical Research in San Antonio under a $1.15 million Phase 1 and Phase 2 Small Business Innovation Research (SBIR) contract. The collaboration aims to optimize CytoSorb for the treatment of burn injury and polytrauma – two other major reasons fighting soldiers die.

Chan says the U.S. Air Force is also funding an FDA-approved, 30-patient randomized control trial, to treat patients who have suffered severe trauma and have evidence of rhabdomyolysis, or severe muscle breakdown. Valued at approximately $3 million, the research’s goal is to treat rhabdomyolysis and the accumulation of a substance called myoglobin, Chan explains. Myoglobin can crystallize in the kidneys, causing kidney failure, which then puts these patients at a much higher risk of death.

At a time when many therapies are designed to boost immune response, Chan says his company is going in the opposite direction.

“We are targeting the other end of the spectrum, where the immune response is too active,” he explains. “We focus on a major unmet medical need in critical care where the immune system is excessively stimulated so that it instead of helping to heal critical injury, it’s actually attacking the patient from within. By providing physicians the potential to effectively control this deadly inflammation for the first time, we hope that CytoSorb will help to revolutionize the treatment of life-threatening illnesses.”

CytoSorbents Inc.
www.cytosorbents.com

About the author: Danny English is an associate editor of TMD and can be reached at denglish@gie.net or 330.523.5354330.523.5354.