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Abstract

Grant Number:	1R43AI056595-01
PI Name:	WILLEFORD, KENNETH O.
PI Email:	kennethw@genebact.com
PI Title:
Project Title:	Biowarfare applications of a new immunoregulator

Abstract: DESCRIPTION (provided by applicant): If biological weapons were to be used by a terrorist organization, the public health system would be overwhelmed. The ease of use and delivery along with the apparent widespread availability of biological weapon grade agents could inflict mass civilian casualties anywhere in the world. The best way to combat and defend bioterrorism is to be prepared. Scientists at GeneBact Biotechnologies, Inc. have discovered a new class of Biological Response Modifiers from mammalian serum that we refer to as the Immune Cell Proliferation Factors ("ICPF"). ICPFs are novel lipoproteins that have been shown to have no direct antimicrobial activity, yet retain their ability to abate microbial pathogenesis as presented in a Salmonella typhimurium mouse model and a Pasteurella multocida avian model. ICPFs also show no direct virucidal activity, yet retain the ability to abate viral pathogenesis as presented in a West Nile Virus mouse model and a Parvovirus rat model. ICPFs were also shown to significantly increase levels of the circulating antibodies to Parvovirus in vaccinated rats when the vaccine was adjuvanted with ICPF as compared to a non-adjuvanted vaccine control. The primary objectives of this project are to (i) establish the safety and efficacy of an ICPF formulation for broad spectrum human use in the treatment of bacteremias and viremias, (ii) evaluate the efficacy of an ICPF formulation to provide prophylactic and therapeutic protection against both bacterial and viral infectious agents, and (iii) evaluate the efficacy of ICPF as and adjuvant in vaccines to amplify and expand existing stores of vaccines. The secondary objective of this project is to evaluate the "immunological memory" conferred upon infected patients treated with ICPF. Accomplishing the Tasks as outlined will provide specific benefits to address biowarfare issues in three major areas: 1. Provide a short-term prophylactic agent for use in high-risk populations such as military personnel entering a biological warfare theater of war. 2. Provide an effective therapeutic agent for personnel exposed to a biological warfare agent. 3. Provide an adjuvant to expand and amplify the existing stockpiles of vaccines.

Thesaurus Terms:
biological response modifier, bioterrorism /chemical warfare, blood lipoprotein, drug design /synthesis /production, drug discovery /isolation, drug screening /evaluation, immunomodulator
antibacterial agent, antiviral agent, bacterial disease, bacterial vaccine, drug preservation, immunologic memory, pathologic process, viral vaccine, virus disease
bioassay, laboratory mouse, laboratory rat, scintillation counter

Institution:	GENEBACT BIOTECHNOLOGIES, INC.
	713 WASHINGTON ST
	MARIETTA, OH 45750
Fiscal Year:	2003
Department:
Project Start:	01-AUG-2003
Project End:	31-JUL-2004
ICD:	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
IRG:	ZRG1

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