Summary of L.E.A.P.S.(TM)* and CEL-1000 Preclinical Animal Studies Conducted with Collaborators

National Institutes of Allergy and Infectious Diseases (NIAID)
Avian (bird) flu
Testing conducted and paid for by NAID
Testing conducted to determine whether CEL-1000 could be used as a potential treatment and/or preventative agent against this virus.
John Hopkins University
Myocarditis (precusor to dilated cardiomyopathy)
Maryland Industrial Partnership (MIPS) & Governmnent grants
Pretreatment and early therapy of Experimental Autoimmune Myocarditis with CEL-1000 resulted in significant reduction of heart enlargement and disease associated histopathological changes in animal models.
Northeastern Ohio Universities College of Medicine (NEUOCOM)
Viral Encephalitis (VE)
U-01 Grant ($1,100,00)
Was shown in mice to protect against VE, a potentially lethal inflamation of the brain. VE is on the U.S. government’s list of priority pathogens for bio-defense research.
U.S. Navy
& CEL-1000
Cooperative Research and Development Agreement (CRADA)
The initial tests conducted in mice. It has been reported that CEL-1000 was 100% protective in mice. Once the optimal combination has been determined, the product will be further tested in primates.
National Instutes of Health (NIH) & the U.S. Army
SARS, smallpox, vaccinia, West Nile virus
Cooperative Agreement
The testing will be conducted to detemine whether CEL-1000 could be used as a potential treatment and/or preventive agent against these diseases.
University of Nebraska Medical Center
Vaccinia and Smallpox infection
Phase I SBIR Grant ($104,000)
The development as a potential therapeutic and prophylactic agent against vaccinia and smallpox infections as a single agent and as an adjuvant for vaccinia vaccines.
Northeastern Ohio Universities College of Medicine (NEUOCOM)
& CEL-1000
Herpes Simplex Virus (HSV)
Phase I and II SBIR Grants ($1,026,000)
CEL-1000 prevents or reduces morbidity and mortality of HSV in mice tested as a treatment, and LEAPS as a vaccine.

No L.E.A.P.S. product has been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans. The safety or efficacy of these products has not been established for any use. Lastly, no definitive conclusions can be drawn from these early-phase, preclinical-trials data involving these investigational products.

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* L.E.A.P.S. is the trademark of CEL-SCI for this investigational platform technology, and this proprietary name is subject to FDA review.

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