SBIR-STTR Award

Acute exposure to mycotoxins can lead to systemic toxicity and even death. With no specific treatment available, aflatoxin and trichothecene T-2 toxin, in particular, are of concern as potential biological weapons due to their toxicity, thermal and UV stability and easy accessibility. As a medical countermeasure, we propose the development of highly porous polymer beads optimized for removal of aflatoxin and T-2 toxin, based on a proven pore capture and surface adsorption technology platform. Previous work has demonstrated significant removal of aflatoxin from whole blood in vitro. We hypothesize removal of >90% of toxin levels in circulation by hemoperfusion will have a significant clinical impact on recovery from exposure. In the current submission, we will demonstrate >90% removal of T-2 toxin from blood in vitro in a BSL-3 facility and identify the minimal polymer dosage required to achieve >90% removal of aflatoxin and T2 toxin. In anticipation of Phase II studies, an animal model and testing facility will be selected and specific protocols submitted for IACUC approval. The outcome will be the demonstration of a safe and effective method for removal of aflatoxin and T-2 toxin from blood, a currently unaddressed area of relevance for biological warfare defense.

Certain species of fungi produce mycotoxins, which can cause acute toxicity and even death in human that either have been, or potentiallycould be, used by bioterroists as weapons of mass destruction. Aflatoxin and trichothecene T-2 toxin are two mycotoxins that are of particularconcern as potential biological weapons due to their toxicity, environmental stability, easy accessibility, historical production for use inbiowarfare and lack of specific therapy. We propose applying our broad spectrum hemoadsorbent CytoSorb as a medical countermeasure. Wehypothesize that hemoadsorption will have a significant impact on survival by directly reducing the toxin level as well as reducing the levels ofdamage-associated molecules released into circulation. During the Phase I, we demonstrated the ability of CytoSorb to efficiently remove>99% of the aflatoxin and T-2 toxin from whole blood in vitro. For Phase II we propose in vivo studies to demonstrate the efficacy our polymerin reducing systemic toxicity caused by mycotoxins. Further we proposed advancing the development of our hemoadsorption device to meetmilitary supply logistics. The outcome will be the demonstration of a safe and effective method for removal of aflatoxin and T-2 toxin fromblood, a currently unaddressed area of relevance for biowarfare defense.