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SMALL MOLECULE INHIBITORS OF SMALLPOX VIRUS REPLICATION

Award Number: R44AI056409
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: 07/31/2009

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SMALL MOLECULE INHIBITORS OF SMALLPOX VIRUS REPLICATION - DESCRIPTION (provided by applicant): Concern over the use of variola virus as a biological weapon has prompted interest in development of small molecule therapeutics for smallpox. Variola virus is highly transmissible and causes severe disease with high mortality rates. Currently, there is no FDA-approved drug for prevention or treatment of smallpox. The overall goal of this smallpox antiviral program is to advance through FDA approval a small molecule antiviral drug for treatment of smallpox. The final drug product will be a safe, effective, and orally administered antiviral compound taken three times or less daily to accommodate treatment, post-exposure prophylactic and prophylactic applications. Our current lead drug candidate, ST-246, is a novel orally bioavailable antiviral compound that is a potent and specific inhibitor of orthopoxvirus replication in vitro and in vivo. ST-246 was discovered during chemical optimization of an initial "hit" that came from a high throughput screen designed to identify inhibitors of vaccinia virus replication. ST-246 and related analogs inhibit vaccinia, cowpox, ectromelia (mousepox), monkeypox, camelpox and variola replication in cell culture but not other unrelated viruses. The compound is well tolerated and orally bioavailable in rodents and monkeys. Moreover, ST-246 protects mice from lethal challenge with vaccinia virus and ectromelia virus and inhibits orthopoxvirus induced disease in normal and immunodeficient mice. It is proposed in this application to advance ST-246 into clinical development by 1) optimizing dosing parameters for in vivo efficacy evaluations, 2) conducting scale up synthesis of ST-246 and initiating formulation studies for drug product manufacture in anticipation of initiating human safety and pharmacology clinical studies 3) completing IND-enabling toxicology assessments, and 4) conducting GLP animal efficacy experiments sufficient to meet animal efficacy rule requirements. These studies will support the investigational new drug (IND) application that will be submitted to the FDA to initiate human clinical trials.


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: 2008 ( Subtotal = $1,829,082 )
2008	2008	SIGA TECHNOLOGIES, INC	420 LEXINGTON AVENUE	NEW YORK	NY	10170	NEW YORK	USA	Allergy and Infectious Diseases Research	000	7	7/29/2008	NON-COMPETING CONTINUATION	$1,829,082
														Subtotal = $1,829,082

Issue Date FY: 2007 ( Subtotal = $1,751,533 )
2007	2007	SIGA TECHNOLOGIES, INC	4575 SW RESEARCH WAY SUITE 230	CORVALLIS	OR	97333	BENTON	USA	Allergy and Infectious Diseases Research	000	6	8/13/2007	NON-COMPETING CONTINUATION	$1,751,533
														Subtotal = $1,751,533

Issue Date FY: 2006 ( Subtotal = $1,513,613 )
2006	2006	SIGA TECHNOLOGIES, INC	4575 SW RESEARCH WAY SUITE 230	CORVALLIS	OR	97333	BENTON	USA	Microbiology and Infectious Diseases Research	000	5	8/1/2006	COMPETING CONTINUATION	$1,513,613
														Subtotal = $1,513,613

Issue Date FY: 2005 ( Subtotal = $2,912,626 )
2005	2005	SIGA TECHNOLOGIES, INC	4575 SW RESEARCH WAY SUITE 230	CORVALLIS	OR	97333	BENTON	USA	Microbiology and Infectious Diseases Research	000	4	8/18/2005	NON-COMPETING CONTINUATION	$2,912,626
														Subtotal = $2,912,626

Issue Date FY: 2004 ( Subtotal = $2,177,971 )
2004	2004	SIGA TECHNOLOGIES, INC	4575 SW RESEARCH WAY SUITE 230	CORVALLIS	OR	97333	BENTON	USA	Microbiology and Infectious Diseases Research	000	3	8/16/2004	COMPETING CONTINUATION	$2,177,971
														Subtotal = $2,177,971

Grand Total All Awards = $10,184,825

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SMALL MOLECULE INHIBITORS OF SMALLPOX VIRUS REPLICATION

Award Number: R44AI056409

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: 07/31/2009

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