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Inhibition of Cardiac Device Induced Cellular Dysfunction in Pigs

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
96328
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
HL102890
Solicitation Year:
N/A
Solicitation Topic Code:
NHLBI
Solicitation Number:
N/A
Small Business Information
NOVELMED THERAPEUTICS, INC.
11000 Cedar Avenue, 135 CLEVELAND, OH 44106-0000
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Woman-Owned: Yes
Minority-Owned: Yes
HUBZone-Owned: Yes
 
Phase 1
Fiscal Year: 2010
Title: Inhibition of Cardiac Device Induced Cellular Dysfunction in Pigs
Agency: HHS
Contract: 1R44HL102890-01A1
Award Amount: $516,118.00
 

Abstract:

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) act ivation 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 ne ar 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 t he 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-specifi c 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 eval uated 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 ex acerbate 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.

Principal Investigator:

Rekha Bansal
4404779874
REKHA@NOVELMED.COM

Business Contact:

Ganesh Iyer
rekha@novelmed.com
Small Business Information at Submission:

NOVELMED THERAPEUTICS, INC.
NOVELMED THERAPEUTICS, INC. 2265 ENTERPRISE PKWY TWINSBURG, OH 44087

EIN/Tax ID: 142159780
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No