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INHIBITION OF CARDIAC DEVICE INDUCED CELLULAR DYSFUNCTION IN PIGS

Award Number: R44HL102890
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/17/2010
PERIOD OF PERFORMANCE END DATE: 07/31/2013

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INHIBITION OF CARDIAC DEVICE INDUCED CELLULAR DYSFUNCTION IN PIGS - DESCRIPTION (provided by applicant): Artificial surfaces of cardiac devices induce cellular activation and platelet dysfunction in patients undergoing bypass procedure. While other pathways may be activated during this process, alternative pathway (AP) activation appears to be one of the important mechanisms for cellular activation and platelet dysfunction in the whole blood model of biomaterial surface-induced activation. Our hypothesis is based on the ex vivo whole blood circulation model demonstrating near complete inhibition of cellular activation, platelet dysfunction, and release of inflammatory mediators by a target-specific mAb. We would like to extend these novel findings utilizing a pig model of cardiopulmonary bypass with an induced occlusion of the descending coronary artery to mimic the clinical setting. During and following circulation through the CPB, high circulating levels of anaphylatoxins, C3a and C5a, and activated neutrophils, monocytes, and platelets are expected. As a result, activated neutrophils and monocytes release inflammatory mediators that cause organ damage and activated platelets become dysfunctional. These events can cause thrombosis, thrombocytopenia, and severe bleeding complications. NovelMed intends to test a target-specific and highly selective monoclonal antibody that blocks AP activation, cellular activation, platelet dysfunction, and blood loss in a pig model of cardiopulmonary bypass. Collective effects of these inflammatory events on multiple organ failure will be evaluated in this proposal using the proposed pig cardiopulmonary bypass model. Proof of concept in a well-accepted pig model of occlusion with CPB is a critical step for furthering the development of NovelMed's lead biologic and moving it towards clinical use. PUBLIC HEALTH RELEVANCE: Billions of dollars are spent annually to prevent systemic inflammatory response in cardiac patients undergoing cardiac procedures with cardiopulmonary bypass to correct partial or complete occlusion of the coronary artery. Cardiac failure can occur if the coronary descending artery is completely occluded. There is currently no approved prophylactic therapeutic for CPB-associated inflammatory responses. When the blood flow in the occluded, ischemia reperfusion injury can exacerbate the response. There is no approved therapeutic for IRI or for CPB associated inflammatory response. NovelMed intends to develop YalcioMab as a treatment to prevent complications that occur as a result of AP activation in the pig model of ischemia with cardiopulmonary bypass.


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: 2012 ( Subtotal = $691,377 )
2012	2012	NOVELMED THERAPEUTICS INC	11000 Cedar Ave Ste 135	Cleveland	OH	44106	CUYAHOGA	USA	Cardiovascular Diseases Research	000	3	8/7/2012	NON-COMPETING CONTINUATION	$691,377
														Subtotal = $691,377

Issue Date FY: 2011 ( Subtotal = $503,352 )
2011	2011	NOVELMED THERAPEUTICS INC	11000 Cedar Ave Ste 135	Cleveland	OH	44106	CUYAHOGA	USA	Cardiovascular Diseases Research	000	2	8/18/2011	EXTENSION WITH OR WITHOUT FUNDS	$503,352
														Subtotal = $503,352

Issue Date FY: 2010 ( Subtotal = $516,118 )
2010	2010	NOVELMED THERAPEUTICS INC	11000 Cedar Ave Ste 135	Cleveland	OH	44106	CUYAHOGA	USA	Cardiovascular Diseases Research	000	1	8/17/2010	NEW	$516,118
														Subtotal = $516,118

Grand Total All Awards = $1,710,847

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INHIBITION OF CARDIAC DEVICE INDUCED CELLULAR DYSFUNCTION IN PIGS

Award Number: R44HL102890

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/17/2010

PERIOD OF PERFORMANCE END DATE: 07/31/2013

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