Novel Anti-Inflammatories for Cardiopulmonary Bypass

Award Information

Agency: Department of Health and Human Services	Branch: N/A	Award ID: 75766	Program Year/Program: 2008 / SBIR
Agency Tracking Number: HL080934	Solicitation Year: N/A	Solicitation Topic Code: N/A	Solicitation Number: N/A

Small Business Information: NOVELMED THERAPEUTICS, INC.
11000 Cedar Avenue, 135 Cleveland, OH 44106-
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Woman-Owned: Yes

Minority-Owned: No

HUBZone-Owned: No

Phase 2: Fiscal Year: 2008

Title: Novel Anti-Inflammatories for Cardiopulmonary Bypass

Agency: HHS

Contract: 2R44HL080934-02

Award Amount: $1,485,330.00

Abstract:
DESCRIPTION (provided by applicant): There is evidence that the complement alternative pathway (AP) contributes significantly to the generation of pro-inflammatory agents in post-CPB inflammation. Complement activation products such as C3a, C5a, and C5b-9 have been found in blood samples of patients undergoing bypass. NovelMed has identified a murine monoclonal antibody to factor B which prevents complement and cellular activation. The antibody also prevents the elastase and TNF production. Murine monoclona l antibodies can not be used as therapeutics due to Human Anti Mouse Antibody (HAMA) response. In this phase II proposal we propose to convert the murine monoclonal into a humanized version of the monoclonal. NovelMed currently has three patents pending on the factor B monoclonal antibodies. The phase II studies should result in an Investigational New Drug (IND) application for the treatment of inflammatory conditions. PUBLIC HEALTH RELEVANCE: Currently there is no FDA approved therapeutic for down regulati ng inflammation in bypass. NovelMed's lead drug BikajuMabTM inhibits C3a, C5a, C5b-9 formation. As a result, activation of neutrophils, monocytes, and platelets is also prevented. In addition BikazuMabTM inhibits TNF-alpha and elastase production, major ha ll mark of inflammatory conditions. Humanized version of the monoclonal is expected to produce similar results and thus provide patient benefit in cardiopulmonary bypass.

Principal Investigator:

Business Contact:

rekha@novelmed.com

Small Business Information at Submission:

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

EIN/Tax ID: 421597802

DUNS: N/A

Number of Employees: N/A

Woman-Owned: No

Minority-Owned: No

HUBZone-Owned: No

Novel Anti-Inflammatories for Cardiopulmonary Bypass

Award Information

Abstract:

Principal Investigator:

Business Contact: