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THERAPEUTIC USE OF INTER-ALPHA INHIBITOR IN SEPSIS

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
60989
Program Year/Program:
2004 / SBIR
Agency Tracking Number:
GM065667
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
PROTHERA BIOLOGICS, LLC
551 Warren Avenue EAST PROVIDENCE, RI -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2004
Title: THERAPEUTIC USE OF INTER-ALPHA INHIBITOR IN SEPSIS
Agency: HHS
Contract: 2R44GM065667-02
Award Amount: $1,501,415.00
 

Abstract:

DESCRIPTION (provided by applicant): The goal of the proposed research is to demonstrate that Inter-alpha serine protease inhibitor proteins (IaIp) are an effective therapy for sepsis. In sepsis, normally high plasma levels of IaIp drop dramatically in adult and newborn patients. We hypothesize that IaIp are consumed while mitigating the damaging effects of circulating proteases. We hypothesize that administration of IaIp will correct the imbalance between IaIp and plasma proteases, thereby preventing organ injuries and high mortality rates in sepsis. Animal studies in a rat cecal ligation/puncture model for sepsis have demonstrated that IaIp helps maintain hemodynamic stability, prevents organ injury, and improves survival. SBIR Phase I studies with highly purified Ialp confirmed Ialp as the preventive agent and showed beneficial effects of Ialp even when administration was delayed up to 10 hrs. after sepsis induction. These results strongly support further development of Ialp as a novel anti-inflammatory agent. In this study, we will scale up the production of human Ialp for preclinical studies in animals and humans to assess its safety, pharmacokinetic properties and efficacy in septic patients. These pilot Phase I/IIa studies will lead to development of novel anti-inflammatory agents for management of sepsis.

Principal Investigator:

Yowpin Lim
4013012046
YOW-PIN_LIM_MD@BROWN.EDU

Business Contact:

M. Yow-pin lim
4013012056
YOW-PIN_LIM_MD@BROWN.EDU
Small Business Information at Submission:

PROTHERA BIOLOGICS, LLC
PROTHERA BIOLOGICS, LLC 87 WALMER AVE EAST PROVIDENCE, RI 02914

EIN/Tax ID: 710868235
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No