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NEUROPROTECTION IN STROKE DRUG DEVELOPMENT

Award Number: R44NS044654
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2002
PERIOD OF PERFORMANCE END DATE: 08/31/2011

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NEUROPROTECTION IN STROKE DRUG DEVELOPMENT - Approximately 800,000 persons in the U.S. suffer an acute stroke each year. There presently is no neuroprotective agent that can be given to patients with acute stroke, and stroke is the third leading cause of death. The costs for rehabilitation of patients that survive a stroke is greater than $40 billion per year in the U.S. The reason that an effective neuroprotective drug has not been developed so far, despite intensive efforts in the pharmaceutical industry, is that most of the drugs do not cross the blood-brain barrier (BBB). Neurotrophins are potential large molecule neuroprotectives but these, too, do not cross the BBB. The present research plan aims at a merger of neurotrophin drug discovery and BBB drug targeting technology, so that a recombinant neurotrophin can be re-formulated as a genetically engineered fusion protein to enable transport of the neurotrophin through the BBB in vivo following delayed intravenous administration in humans. Such a drug will cause neuroprotection in stroke patients following intravenous administration, because the neuroprotective agent will have been specifically designed to cross the BBB. Prior work has produced AGT-120, which is a genetically engineered fusion protein wherein the neurotrophin variant is fused to a targeting ligand that undergoes receptor-mediated transport across the BBB in vivo. This BBB transport vector has been previously genetically engineered to enable use in humans without immunological reaction. The fusion protein is a bi-functional molecule that not only crosses the BBB, but also binds to the specific neurotrophin receptor on neurons to cause neuronal neuroprotection. The following will be done in the proposed work: (i) pharmacology/toxicology of AGT-120 under Good Laboratory Practise conditions, (ii)submission of an IND to the FDA for single intravenous administration of AGT-120 to patients with acute stroke, (iii) phase l-ll clinical trial to examine safety, tolerability, and pharmacokinetics, and to explore the efficacy of intravenous AGT-120 within 5 hours of an acute stroke. AGT-120 is the first large molecule neuroprotective that has been specifically formulated to cross the BBB in humans following intravenous administration.


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	ARMAGEN TECHNOLOGIES INC	914 COLORADO BOULEVARD	LOS ANGELES	CA	90401		USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	6/15/2010	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2009 ( Subtotal = $0 )
2009	2008	ARMAGEN TECHNOLOGIES INC	914 COLORADO BOULEVARD	LOS ANGELES	CA	90401		USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	11/3/2008	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2008 ( Subtotal = $977,098 )
2008	2008	ARMAGEN TECHNOLOGIES INC	914 COLORADO BOULEVARD	LOS ANGELES	CA	90401		USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	8/28/2008	NON-COMPETING CONTINUATION	$977,098
														Subtotal = $977,098

Issue Date FY: 2007 ( Subtotal = $977,098 )
2007	2007	ARMAGEN TECHNOLOGIES INC	914 COLORADO BOULEVARD	LOS ANGELES	CA	90401		USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	9/25/2007	NON-COMPETING CONTINUATION	$977,098
														Subtotal = $977,098

Issue Date FY: 2006 ( Subtotal = $1,377,500 )
2006	2006	ARMAGEN TECHNOLOGIES INC	11301 OLYMPIC BOULEVARD	LOS ANGELES	CA	90064	LOS ANGELES	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	9/30/2006	COMPETING CONTINUATION	$1,377,500
														Subtotal = $1,377,500

Issue Date FY: 2005 ( Subtotal = $375,000 )
2005	2005	ARMAGEN TECHNOLOGIES INC	11301 OLYMPIC BOULEVARD	LOS ANGELES	CA	90064	LOS ANGELES	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	3/3/2005	NON-COMPETING CONTINUATION	$375,000
														Subtotal = $375,000

Issue Date FY: 2004 ( Subtotal = $375,000 )
2004	2004	ARMAGEN TECHNOLOGIES INC	11301 OLYMPIC BOULEVARD	LOS ANGELES	CA	90064	LOS ANGELES	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	5/3/2004	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$330,100
2004	2004	NEUROGENE TECHNOLOGIES LLC	11301 OLYMPIC BOULEVARD	LOS ANGELES	CA	90064	LOS ANGELES	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	3/1/2004	COMPETING CONTINUATION	$44,900
														Subtotal = $375,000

Grand Total All Awards = $4,081,696

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NEUROPROTECTION IN STROKE DRUG DEVELOPMENT

Award Number: R44NS044654

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2002

PERIOD OF PERFORMANCE END DATE: 08/31/2011

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