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Neutralizing Antibodies for Complement Inhibition

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
95734
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
AI085697
Solicitation Year:
N/A
Solicitation Topic Code:
NIAID
Solicitation Number:
N/A
Small Business Information
NOVELMED THERAPEUTICS, INC.
11000 Cedar Avenue, 135 CLEVELAND, OH 44106-0000
View profile »
Woman-Owned: Yes
Minority-Owned: Yes
HUBZone-Owned: Yes
 
Phase 1
Fiscal Year: 2010
Title: Neutralizing Antibodies for Complement Inhibition
Agency: HHS
Contract: 1R43AI085697-01
Award Amount: $300,000.00
 

Abstract:

DESCRIPTION (provided by applicant): Ischemia-reperfusion (I/R) injury is a common clinical event, which has the potential to seriously affect, and sometimes result in death, of the patient. Interruption of the blood supply causes ischemia, which rapidly d amages metabolically active tissues. Paradoxically, restoration of blood flow to the ischemic tissues initiates a cascade of pathology that leads to additional cell or tissue injury, termed ischemic reperfusion injury (IRI). I/R is a potent inducer of alte rnative pathway complement (AP) activation, an event that induces additional cell or tissue injury. In the process of reperfusion, dead cells are targeted for removal by the innate immune system, particular the AP, however, in this process normal healthy c ells (innocent bystanders) are also destroyed. Clinical and experimental studies in heart, gut, kidney, limb and liver have shown that I/R results in AP activation with subsequent production of the complement factors, C3a, C5a and membrane attack complex ( MAC). MAC promotes cell lysis in the ischemic tissue, while C3a and C5a are potent pro-inflammatory mediators that activate cells of the innate immune system and up regulate their production of proinflammatory cytokines. In this manner, AP activation resul ts in the production of a number of inflammatory mediators that further promote cell death and tissue injury. Our work focuses on preventing the reperfusion injury and cell death that occurs when the blood flow is re-stored in the ischemic area of tissues. NovelMed has developed a novel monoclonal antibody therapeutic that specifically prevents activation of the AP and AP-mediated inflammation that induces further tissue damage with reperfusion. NovelMed's lead drug candidate binds and neutralizes a critica l protein of the AP to prevent AP activation. NovelMed has strong in vitro and ex vivo data demonstrating that the monoclonal antibody inhibits C3a and C5a production, down regulates neutrophil, monocyte, and platelet activation and prevent production of p roinflammatory mediators that these activated cells produce. Preliminary data also indicate that this biologic treatment reduces IRI in a heart IRI animal model. The goals of this phase I SBIR is to complete feasibility studies demonstrating the therapeuti c value of developing this cutting-edge monoclonal antibody technololgy to prevent IRI. This novel biologic inhibitor may find wide clinical applications,as there are no effective drug therapies currently available to prevent or treat IRI. . PUBLIC HEAL TH RELEVANCE: Monoclonal antibody based therapeutics are known to be cutting-edge technology. Ischemia-reperfusion (I/R) injury is a common clinical event, which can adversely affect patient health and can result in patient death. Interruption of the bloo d supply causes ischemia, which rapidly damages metabolically active tissues. Paradoxically, restoration of blood flow to the ischemic tissues initiates a cascade of pathology that leads to additional cell or tissue injury, termed ischemic reperfusion inju ry (IRI). The cascade of pathology that leads to additional cell and tissue injury is largely explained by complement activation and inhibitor of complement activation prevents IRI. NovelMed intends to develop it lead biologic, YalcioMab, an alternative pa thway complement activation inhibitor, as a treatment to prevent the serious and often life-threatening complications associated with IRI.

Principal Investigator:

Rekha Bansal
4404779874
REKHA@NOVELMED.COM

Business Contact:

Rekha Bansal
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