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Novel Treatments to Abolish Inflammatory Mediators in Hemodialysis

Award Number: R44DK082025
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2008
PERIOD OF PERFORMANCE END DATE: 07/31/2016

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Novel Treatments to Abolish Inflammatory Mediators in Hemodialysis - DESCRIPTION (provided by applicant): NovelMed intends to develop a humanized anti-Bb antibody as a prophylactic treatment for inflammatory responses associated with hemodialysis. During this procedure, blood contacts the artificial surfaces of the dialyzer, activating the alternative complement pathway (AP). AP activation causes cellular activation and production of inflammatory mediators with potent inflammatory properties. When a patient with chronic kidney disease undergoes repeated dialysis procedures, these inflammatory mediators accumulate and cause persistent secondary organ damage over time. We have shown that Bikaciomab prevents AP activation, cellular activation and production of inflammatory mediators in whole blood circulating through the hemodialyzer. Bikaciomab has a unique mechanism of action as this antibody binds C3 and C5 convertase and neutralizes their proteolytic activity required for the propagation of the alternative complement pathway. This approach appears to be clinically viable given large number of indications where such a drug can be tested and used. The proposed therapeutic strategy is a single drug strategy that effectively prevents an array of inflammatory mediators known to generate potent inflammation. Recent publication underlines the role of complement for the treatment of inflammatory response due to hemodialysis. Murine anti-Bb has been humanized using recombinant engineering. The monoclonal demonstrates high affinity, target selectivity and is ready to be tested in the dialysis system. Now that the humanized antibody is available, its further development as a clinically viable product is proposed for renal disorders. The scientific, regulatory, safety and business development team has been established to conduct the proposed 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: 2017 ( Subtotal = $0 )
2017	2015	NOVELMED THERAPEUTICS INC	11000 CEDAR AVENUE, 135	CLEVELAND	OH	44106	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	12/7/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $601,912 )
2015	2015	NOVELMED THERAPEUTICS INC	11000 Cedar Ave Ste 135	Cleveland	OH	44106	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	9/4/2015	NON-COMPETING CONTINUATION	$601,912
														Subtotal = $601,912

Issue Date FY: 2014 ( Subtotal = $849,661 )
2014	2014	NOVELMED THERAPEUTICS INC	11000 Cedar Ave Ste 135	Cleveland	OH	44106	CUYAHOGA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	7/23/2014	COMPETING CONTINUATION	$849,661
														Subtotal = $849,661

Grand Total All Awards = $1,451,573

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Novel Treatments to Abolish Inflammatory Mediators in Hemodialysis

Award Number: R44DK082025

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2008

PERIOD OF PERFORMANCE END DATE: 07/31/2016

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