NovelMed's lead drug candidate prevents biomaterials induced cellular activation. Activated cells release inflammatory mediators that are responsible for pathological trauma that leads to cardiac, lung, liver, and brain injuries during surgical procedures that require cardiac devices. Our findings provide convincing support for developing YalcixiMab as a treatment to prevent biomaterial-induced inflammation that occurs during surgical procedures. CPB circuits are used during various procedures for heart transplant, and valve replacements. Treatment of blood with YalcioMab prior to the extracorporeal circulation prevents complement activation, neutrophil activation, monocyte activation, platelet activation and the formation of leukocyte-platelet aggregates. The drug also prevents the release of potent inflammatory mediators such as TNF-a.

Public Health Relevance

NovelMed is developing treatments that will reduce/prevent complications that arise when blood is exposed to biomaterial surfaces of the cardiac devices. Cardiopulmonary bypass circuits is utilized in several cardiac surgeries as a heart-lung machine while surgeons perform procedures on the empty heart. The present grant application will extend our in vitro and ex vivo findings demonstrating that complement-induced inflammation is inhibited by our monoclonal antibody-based therapeutic.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44HL099015-03
Application #
8309859
Study Section
Special Emphasis Panel (ZRG1-SBTS-E (10))
Program Officer
Miller, Marissa A
Project Start
2010-05-01
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2014-06-30
Support Year
3
Fiscal Year
2012
Total Cost
$633,313
Indirect Cost
Name
Novelmed Therapeutics, Inc.
Department
Type
DUNS #
190155171
City
Cleveland
State
OH
Country
United States
Zip Code
44106