Replies to post #4211 on CytoSorbents Corporation (CTSO)

[Makenlight]

CytoSorbents Corporation Announces Additional Data From European Sepsis Trial

Wednesday September 7, 2011


"As expected, there is also a good correlation between CytoSorb™ cytokine reduction and outcome in patients with highly elevated IL-6 levels (greater than or equal to 1,000 pg/mL) or IL-1ra (greater than or equal to 16,000 pg/mL) which are both known, independent predictors of mortality in sepsis. In these patients, CytoSorb™ treatment showed positive trends to benefit in 28-day all-cause mortality (0% vs 62.5% control, n = 14), fewer patients on mechanical ventilation at 28 days (33% vs 88% control), and fewer days in the ICU (23.8 vs 27.5 days control).

CytoSorbents had previously reported that the primary endpoint of the study had been achieved with an average IL-6 reduction of 49.1% (p = 0.01) across the 7-day treatment period. Analysis of other important cytokines demonstrated similar patterns of reduction including MCP-1 (-49.5%, p = 0.002), IL-1ra (-36.5%, p = 0.001) and IL-8 (-30.2%, 0.002) with additional cytokine analysis ongoing. These data further confirm the effectiveness of CytoSorb™ as a broad cytokine filter and its ability to reduce cytokine storm in patients with sepsis. Treatment was well-tolerated across more than 300 treatments without serious device related adverse events."

http://www.cytosorbents.com/news46.htm

[ping_pow_princess]

CytoSorb has a safety track record. It has been used in more than 650 human treatments without serious device-related adverse events. (number from mid-2012).

In addition, I recently asked Dr Chan about cytokine removal (from their product brochure), that is probably close to answering your concern, here is his comment: "In terms of the cytokine data, the data on near complete removal is in horse serum. This is a different environment from whole blood which is significantly harder to remove cytokines from. The horse serum experiments indicate that the pores are ideally configured to remove a broad range of cytokines. But in whole blood, it is a much more complex milieu in which cytokines are often bound in equilibrium to cells and other whole blood components. As you lower plasma levels of cytokines, it shifts the equilibrium and more dissociates from the cellular reservoir and so on. In the influenza case report that is now in our investor presentation, you will note that cytokine extraction is very aggressive up front. This is based on concentration gradient and "driving force". As cytokine levels approach more reasonable levels in days 5-7 (still elevated but not toxic) the extraction efficiency drops off significantly. This is, in fact, important to the safety of our technology. We call it "self titration". Or in other words, the device "turns itself off" so to speak and it becomes much harder to over treat. Complete elimination of cytokines increases mortality in animal models of sepsis, probably because the immune system is then compromised. Our technology is more of an immunomodulation strategy that reduces cytokines to non-toxic levels to "reset" the immune response without ablating it."