Methods and compositions for the treatment of radiation-related disorders

Abstract

This invention relates, in part, to methods and compositions that are useful for the treatment and/or prevention of various disorders, including radiation-related disorders, such as acute radiation syndrome.

1 .- 32 . (canceled) 
     
     
         33 . A method of preventing gastrointestinal damage following exposure to radiation in a human patient, the method comprising administering to the human patient not more than a single dose of an effective amount of a composition comprising entolimod, wherein the effective amount is about 0.4 to about 0.6 μg/kg, and wherein the entolimod comprises the amino acid sequence of SEQ ID NO: 1. 
     
     
         34 . The method of  claim 33 , wherein the exposure to radiation occurs as a result of a radiation disaster. 
     
     
         35 . The method of  claim 33 , wherein the irradiation is a high dose of radiation of at least 2 Gy. 
     
     
         36 . The method of  claim 33 , wherein the high dose of radiation is sufficient for a classification of Unit Radiation Exposure Status of RES 3. 
     
     
         37 . The method of  claim 33 , wherein the human patient is administered entolimod within about 48 hours of being exposed to radiation. 
     
     
         38 . The method of  claim 33 , wherein the human patient is administered entolimod within one or more of the triage, emergency care, and definitive care stages of radiation exposure. 
     
     
         39 . The method of  claim 33 , wherein entolimod is administered parenterally or orally. 
     
     
         40 . The method of  claim 33 , wherein entolimod is administered by a single intramuscular injection. 
     
     
         41 . The method of  claim 33 , wherein entolimod is administered by controlled-release or sustained-release. 
     
     
         42 . The method of  claim 33 , wherein the human patient presents a lymphocyte count reduction of about 50% within about 24 to about 48 hours of being exposed to radiation. 
     
     
         43 . The method of  claim 33 , wherein the human patient's lymphocyte count is less than about 1000/μL. 
     
     
         44 . The method of  claim 33 , wherein the treatment with entolimod is used as an adjuvant or neoadjuvant to one or more of blood products, colony stimulating factors, cytokines and/or growth factors, antibiotics, diluting and/or blocking agents, mobilizing or chelating agents, stem cell transplants, antioxidants or free radicals, and radioprotectants. 
     
     
         45 . The method of  claim 33 , wherein entolimod induces expression of NF-κB through toll-like receptor (TLR)-mediated activation.