Atox Bio and Fast-Track Drugs and Biologics Sign an R&D Collaboration Agreement
News Jun 25, 2009
Atox Bio Ltd., a subsidiary of Yissum Research Development Company Ltd., and Fast-Track Drugs & Biologics LLC today announced the initiation of a joint R&D program to continue the development of Atox Bio's novel mechanism-based immunomodulator peptide, AB103, for the treatment of sepsis and septic shock.
The collaboration includes advanced pre-clinical studies and a Phase I clinical trial to be performed at the University of Maryland, Baltimore, U.S.A. The collaborative R&D program has won the support of the Israel-U.S. Binational Industrial Research and Development Fund (BIRD) for the amount of $575,000.
AB103 is a novel mechanism-based immunomodulator that attenuates the excessive Th1 cytokine responses caused by the majority of sepsis virulence factors: Gram-positive bacteria, Gram-negative bacteria and superantigen toxins. This exaggerated immune response causes sepsis and septic shock, conditions that lead to high mortality rates.
AB103 leaves a basal Th1 response intact; thus, the normal immune response is not compromised. AB103 is a short peptide, originally developed as superantigen antagonist for the treatment of toxic shock. The novel treatment is based on the research of Atox Bio co-founders Drs. Raymond Kaempfer and Gila Arad, from the Faculty of Medicine of the Hebrew University, which was performed with U.S. government funding (US Army, Defense Advanced Research Projects Agency and National Institute of Allergy and Infectious Disease).
Uri Danon, Atox Bio's CEO stated, "This collaboration combines Atox Bio's break-through technology, the proven regulatory and clinical management capabilities of Fast-Track and the University of Maryland School of Medicine’s strong clinical capabilities. This combined expertise will contribute to the success of the collaborative R&D program."
Severe sepsis and septic shock are life-threatening illnesses characterized by an excessive systemic host immune response to causative bacteria and their toxins that overwhelms the body, causing 215,000 deaths a year in the U.S. alone. Severe sepsis and septic shock constitute one of the main causes of death in the intensive care unit (ICU). Sepsis is caused primarily by Gram-positive and Gram-negative bacteria.
Gram-positive bacteria cause severe sepsis and septic shock both by secreting superantigens and via components of their cell walls. Superantigens are lethal toxins, potent activators of Th1 cytokines that have acute effects on the immune system, causing severe sepsis, septic and toxic shock.
Despite antimicrobial agents and optimal supportive care, mortality from sepsis is still over 30%. The sole approved adjunctive treatment for severe sepsis and septic shock is Xigris® which reduces mortality by 6%, leaving a major unmet medical need.