Preliminary study results of ExThera Medical's Seraph extracorporeal affinity therapy published

ExThera Medical announced today that the results of a preliminary study (“Cytokines in blood from septic patients interact with surface immobilized heparin”) of its proprietary medical device, Seraph™ extracorporeal affinity therapy, have been published in the current issue of the Journal of the American Society for Artificial Organs (Jan.-Feb. 2010).

“The removal of blood-borne pathogens by adsorption onto heparinized surfaces such as Seraph may become a viable method for treating sepsis patients at both the onset and advanced stage of the disease”

One very important clinical application of Seraph (Selective Removal by Apheresis) is expected to be the treatment of sepsis within intensive care units. Seraph consists of a specially designed cartridge packed with a novel bioactive polymer substrate that acts as a hemofilter. By incorporating immobilized heparin, the cartridge’s high-surface-area can safely and selectively reduce cytokine levels and remove certain pathogens from a patient’s blood before the blood is (re)infused.

In the study conducted at the Karolinska Institute in Stockholm, Sweden, when blood from septic patients was passed through a miniature version of the Seraph cartridge, concentrations of pro-inflammatory cytokine tumor necrosis factor-α (TNF-α) were “significantly reduced from initially very high levels.” In the control group, passage of blood from septic patients over non-heparinized beads did not affect the TNF-α levels. “We conclude that surface heparinization may be a useful technique for selectively regulating the levels of heparin-binding cytokines from whole blood. This may have implications for the treatment of hyper-inflammatory conditions such as severe sepsis,” said principal investigator Jonas Axelsson, M.D., Ph.D., of Karolinska Institute’s Department of Renal Medicine.

“The removal of blood-borne pathogens by adsorption onto heparinized surfaces such as Seraph may become a viable method for treating sepsis patients at both the onset and advanced stage of the disease,” said George Pitarra, President and Managing Director of Emergence LLC. “Although a considerable amount of clinical work remains to be done, we are extremely encouraged by the results of the Karolinska study.”

“It is well-established that heparin can bind an enormous variety of peptides with high specificity at the appropriate binding sites,” added Olle Larm, Ph.D., CEO of ExThera AB. “In addition to the affinity of heparin for cytokines, heparin also is capable of binding the pathogens responsible for the onset of sepsis as previously demonstrated during our earlier in vitro experiments and now in this ex vivo study at the Karolinska Institute. Apheresis based on a bioactive heparinized polymer surface such as Seraph avoids the constraints of drugs, which typically target only one pathogen and do not affect the cytokine level. The combination of specific removal of cytokines and the removal of pathogens from the blood stream may give clinicians a new paradigm for treating septic patients.”

“The use of bioactive synthetic polymers to treat or even cure disease may open a whole new area of application for biomaterials—which have previously been used after the fact—to rebuild, replace or augment body parts already damaged by disease and trauma,” added Bob Ward, Chairman of Emergence LLC. “I am very happy to be working on this project with Professor Olle Larm and his team, as Dr. Larm pioneered the surface heparinization of biomaterials in blood contacting medical devices.”