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ANTIVIRAL DRUGS FOR LASSA FEVER VIRUS

Award Number: R44AI056525
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2003
PERIOD OF PERFORMANCE END DATE: 08/31/2010

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ANTIVIRAL DRUGS FOR LASSA FEVER VIRUS - DESCRIPTION (provided by applicant): Hemorrhagic fever viruses are of serious worldwide health concern as well as potential biological weapons. Lassa fever virus in particular annually infects several hundred thousand individuals in West Africa, and the export of this pathogen outside of this region, either intentionally or unintentionally, presents a serious risk to the developed countries of the world. The CDC and NIAID have identified Lassa fever virus as a Category A priority pathogen, indicating the highest degree of threat to public health. The purpose of our biodefense program is to develop safe and effective drugs for preventing and treating diseases caused by Category A viruses. To that end, a large and diverse library of small molecule compounds was screened to identify inhibitors that target the essential Lassa surface glycoprotein and thus block viral entry into the host cell. A number of these potent antiviral compounds and their related analogs have exhibited informative chemical structure-biological activity relationships (SAR). The goal of the Phase II proposal is to advance these compounds toward clinical development, to submit an application for an Investigational New Drug (IND) for the strongest candidate, and to identify at least one additional preclinical candidate as a potential back-up compound if needed. Lead compounds will be optimized by criteria of potency, toxicity, metabolism, and pharmacokinetics. Compounds that demonstrate acceptable traits will be evaluated for efficacy in animal models of Lassa fever. These experiments will be performed initially in guinea pigs, with efficacious compounds further tested in nonhuman primates. In addition, the mechanism of antiviral action will be explored both directly and by examination of prospective viral escape mutants. Replication-deficient retroviruses that incorporate a heterologous envelope protein such as the Lassa fever virus glycoprotein (viral pseudotypes) will be used to assess compound potency and mechanism of action; these experiments can be performed using biosafety level 2 (BSL-2) conditions. Results will be validated in BSL-4 facilities using authentic Lassa fever virus; animal studies using Lassa fever virus will also be conducted in BSL-4 facilities.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2010 ( Subtotal = $0 )
2010	2008	SIGA TECHNOLOGIES, INC	35 EAST 62ND STREET	NEW YORK	NY	10065	NEW YORK	USA	Microbiology and Infectious Diseases Research	000	7	3/5/2010	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2008 ( Subtotal = $3,901,282 )
2008	2008	SIGA TECHNOLOGIES, INC	420 LEXINGTON AVENUE	NEW YORK	NY	10170	NEW YORK	USA	Microbiology and Infectious Diseases Research	000	7	8/18/2008	NON-COMPETING CONTINUATION	$3,901,282
														Subtotal = $3,901,282

Issue Date FY: 2007 ( Subtotal = $1,160,831 )
2007	2007	SIGA TECHNOLOGIES, INC	4575 SW RESEARCH WAY SUITE 230	CORVALLIS	OR	97333	BENTON	USA	Microbiology and Infectious Diseases Research	000	6	8/30/2007	NON-COMPETING CONTINUATION	$1,160,831
														Subtotal = $1,160,831

Issue Date FY: 2006 ( Subtotal = $974,954 )
2006	2006	SIGA TECHNOLOGIES, INC	4575 SW RESEARCH WAY SUITE 230	CORVALLIS	OR	97333	BENTON	USA	Microbiology and Infectious Diseases Research	000	5	8/31/2006	COMPETING CONTINUATION	$974,954
														Subtotal = $974,954

Issue Date FY: 2005 ( Subtotal = $3,214,689 )
2005	2005	SIGA TECHNOLOGIES, INC	4575 SW RESEARCH WAY SUITE 230	CORVALLIS	OR	97333	BENTON	USA	Microbiology and Infectious Diseases Research	000	4	9/9/2005	NON-COMPETING CONTINUATION	$3,214,689
														Subtotal = $3,214,689

Issue Date FY: 2004 ( Subtotal = $2,092,539 )
2004	2004	SIGA TECHNOLOGIES, INC	4575 SW RESEARCH WAY SUITE 230	CORVALLIS	OR	97333	BENTON	USA	Microbiology and Infectious Diseases Research	000	3	8/11/2004	COMPETING CONTINUATION	$2,092,539
														Subtotal = $2,092,539

Grand Total All Awards = $11,344,295

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ANTIVIRAL DRUGS FOR LASSA FEVER VIRUS

Award Number: R44AI056525

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2003

PERIOD OF PERFORMANCE END DATE: 08/31/2010

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