Therapy Areas: Cardiovascular
CytoSorbents REFRESH 2-AKI Protocol Amendment Approved by FDA
5 September 2018 - - US-based critical care immunotherapy specialist CytoSorbents Corp.'s (NASDAQ: CTSO) REFRESH 2-AKI trial protocol amendment, which the company discussed in its 2 August earnings press release, has now been approved by the US Food and Drug Administration, the company said.

Based on the recommendations of key clinical advisors, a protocol amendment was submitted to the FDA to improve operational aspects of the patient screening process and expand the inclusion criteria.

These changes were back-tested against patient screening logs and were designed to facilitate enrollment and broaden the applicable market for CytoSorb.

The approved amendment has now been distributed to 9 active clinical trial sites, 7 additional sites nearing budget and contract finalization, and 9 additional sites completing start-up activities, awaiting individual ethics committee review.

CytoSorbents is in critical care immunotherapy, specialising in blood purification.

Its flagship product, CytoSorb is approved in the European Union with distribution in 53 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses.

These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure.

CytoSorbents recently initiated its pivotal REFRESH 2-AKI trial a multi-center, randomized controlled, clinical trial intended to support US regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. CytoSorb has been used in more than 46,000 human treatments to date.

CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption.

Its technologies have received non-dilutive grant, contract, and other funding of approximately USD 25m from DARPA, the US Army, the US Department of Health and Human Services, the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI), US Special Operations Command (USSOCOM), and others.

The company has numerous products under development based upon this unique patented blood purification technology including CytoSorb-XL, HemoDefend, VetResQ, K+ontrol, ContrastSorb, DrugSorb, and others.
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