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CD24 AS THERAPEUTIC TARGET FOR MULTIPLE SCLEROSIS-PHASE II COMPETING RENEWAL

Award Number: R44NS041692
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: 09/30/2001
PERIOD OF PERFORMANCE END DATE: 02/29/2012

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CD24 AS THERAPEUTIC TARGET FOR MULTIPLE SCLEROSIS-PHASE II COMPETING RENEWAL - DESCRIPTION (provided by applicant): The ultimate goal of our research and development program in multiple sclerosis (MS) is to develop a novel MS drug that targets CD24, a GPI-anchored surface glycoprotein that serves as a unique and critical checkpoint for MS pathogenesis. During our previous studies supported by the phase I and phase II grants, we produced a fusion protein between the CD24 extracellular domain and the human IgG1 heavy chain Fc region and showed that the fusion protein has a significant effect on the acute EAE clinical score even when applied after the onset of the disease. Moreover, the fusion protein reduced disease severity and reduced the rate of relapses in the relapsing EAE model. Remarkably, the fusion protein has a very long half-life in vivo and showed no toxicity in the mouse model. The potential relevance of the CD24 target in human multiple sclerosis is substantiated by our discoveries that the polymorphism of CD24 is a genetic modifier for the risk and progression of multiple sclerosis. In collaboration with Gala, a division of Cardinal Health, Inc., we have produced cell lines that stably secrete high levels of CD24. A GLP toxicity lot of more than 60 grams of fusion protein has been produced and 140 grams of cGMP grade product was manufactured as well. In the next phase, we will carry out the necessary studies for an investigative new drug (IND) filing with the Food and Drug Administration. At the same time, we will analyze the immunological and non-immunological mechanisms by which CD24Ig works as a therapeutic drug for MS. Our proposed studies will provide data for IND filing and will therefore pave the way for clinical trials of the novel drug. They will mark the most important milestones in a project that has been supported by the SBIR grant, aimed at developing novel therapeutics for MS with implications in other neurological and autoimmune diseases. PUBLICE HEALTH RELEVANCE: The project is proposed to continue our current research and finalize necessary studies for an investigative new drug (IND) filing with the Food and Drug Administration. This will lead us through phase I and phase II clinical trials and toward the development of a novel drug for multiple sclerosis, with implications for other neurological diseases.


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: 2011 ( Subtotal = $0 )
2011	2010	ONCOIMMUNE	1474 BRIDGETON DRIVE	COLUMBUS	OH	43224	FRANKLIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	4/26/2011	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2010 ( Subtotal = $493,610 )
2010	2010	ONCOIMMUNE	1275 Kinnear Rd	Columbus	OH	43212	FRANKLIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	3/29/2010	NON-COMPETING CONTINUATION	$493,610
														Subtotal = $493,610

Issue Date FY: 2009 ( Subtotal = $1,444,734 )
2009	2009	ONCOIMMUNE	1275 Kinnear Rd	Columbus	OH	43212	FRANKLIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	5	2/11/2009	NON-COMPETING CONTINUATION	$1,444,734
2009	2008	ONCOIMMUNE	1474 BRIDGETON DRIVE	COLUMBUS	OH	43224	FRANKLIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	12/8/2008	COMPETING CONTINUATION	$0
														Subtotal = $1,444,734

Issue Date FY: 2008 ( Subtotal = $469,280 )
2008	2008	ONCOIMMUNE	1474 BRIDGETON DRIVE	COLUMBUS	OH	43224	FRANKLIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	7/25/2008	COMPETING CONTINUATION	$469,280
														Subtotal = $469,280

Issue Date FY: 2005 ( Subtotal = $363,476 )
2005	2005	ONCOIMMUNE	1474 BRIDGETON DRIVE	COLUMBUS	OH	43224	FRANKLIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	8/18/2005	NON-COMPETING CONTINUATION	$363,476
														Subtotal = $363,476

Issue Date FY: 2004 ( Subtotal = $502,000 )
2004	2004	ONCOIMMUNE	1474 BRIDGETON DRIVE	COLUMBUS	OH	43224	FRANKLIN	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	9/20/2004	COMPETING CONTINUATION	$502,000
														Subtotal = $502,000

Grand Total All Awards = $3,273,100

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CD24 AS THERAPEUTIC TARGET FOR MULTIPLE SCLEROSIS-PHASE II COMPETING RENEWAL

Award Number: R44NS041692

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: 09/30/2001

PERIOD OF PERFORMANCE END DATE: 02/29/2012

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