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Optimization of a Combined Drug and Delivery Device for Treatment of Cyanide Poisoning

Award Number: U01NS112125
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2019
PERIOD OF PERFORMANCE END DATE: 07/31/2025

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Optimization of a Combined Drug and Delivery Device for Treatment of Cyanide Poisoning - Principal Investigator/Program Director (Last, First, Middle): Patterson, Steven E. Project Summary/Abstract The risk of cyanide use in a terrorist attack resulting in a mass casualties is genuine and cyanide is included on the Chemical Threat Risk Assessment (CTRA) list. In response the NIH CounterACT charge to develop effective medical countermeasures, this project is focused on development of an effective drug/device combination to deliver our rapidly acting antidote, sulfanegen, to victims of cyanide exposure. We have previously demonstrated that sulfanegen, a novel cyanide antagonist discovered in our labs, (Patterson, Center for Drug Design) is effective in reversing lethal cyanide toxicity in murine, swine and rabbit models of cyanide exposure. Our demonstration of sulfanegen’s efficacy includes dose optimization, pharmacokinetics, species justification, formulation optimization, and safety assessment. In order to furthere develop our countermeasure, Windgap Medical’s autoinjector design will be customized to accommodate sulfanegen’s dosing characteristics. The Windgap Medican-Minnesota consortium’s ultimate goals are to 1) obtain an IND/IDE from the FDA, 2) conduct clinical trials and 3) FDA approval under the animal rule. The focus of this proposal is therefore on development of an optimized combined autoinjector/sulfanegen lead, demonstration of this lead’s efficacy and safety in non-GLP studies according to PAR-16-331, and establish the basis for a later round of funding under BARDA that will allow IND enabling studies.


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: 2025 ( Subtotal = $0 )
2025	2023	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	2/20/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	6/4/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $713,862 )
2023	2023	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	5	8/14/2023	NON-COMPETING CONTINUATION	$713,862
2023	2022	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	5/18/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $713,862

Issue Date FY: 2022 ( Subtotal = $662,943 )
2022	2022	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	9/2/2022	NON-COMPETING CONTINUATION	$662,943
2022	2021	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	12/21/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $662,943

Issue Date FY: 2021 ( Subtotal = $615,727 )
2021	2021	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	8/24/2021	NON-COMPETING CONTINUATION	$615,727
														Subtotal = $615,727

Issue Date FY: 2020 ( Subtotal = $505,514 )
2020	2020	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	7/24/2020	NON-COMPETING CONTINUATION	$505,514
2020	2019	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	1/30/2020	NEW	$0
														Subtotal = $505,514

Issue Date FY: 2019 ( Subtotal = $571,768 )
2019	2019	REGENTS OF THE UNIVERSITY OF MINNESOTA	200 OAK ST SE # 224	MINNEAPOLIS	MN	55455	HENNEPIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/3/2019	NEW	$571,768
														Subtotal = $571,768

Grand Total All Awards = $3,069,814

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Optimization of a Combined Drug and Delivery Device for Treatment of Cyanide Poisoning

Award Number: U01NS112125

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/15/2019

PERIOD OF PERFORMANCE END DATE: 07/31/2025

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