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Development of an Antimicrobial Cellular Therapeutic for Inhibition of Biofilm…

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2011 / SBIR
Agency Tracking Number:
R44AI090778
Solicitation Year:
2011
Solicitation Topic Code:
NIAID
Solicitation Number:
AI09-029
Small Business Information
Stratatech Corporation
505 S. Rosa Road, Suite 169 Madison, WI -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2011
Title: Development of an Antimicrobial Cellular Therapeutic for Inhibition of Biofilm Fo
Agency: HHS
Contract: 4R44AI090778-02
Award Amount: $3,000,000.00
 

Abstract:

DESCRIPTION (provided by applicant): Chronic and infected wounds significantly affect the quality of life for millions of US citizens and are associated with increased risk of complications including the devastating consequence of amputation. As of 2006, infections of diabetic foot ulcers resulted in 82,000 amputations each year and it has been estimated that these numbers will increase by 10% annually. Moreover, in an extensive study of several types of chronic wounds including diabetic foot ulcers, venousleg ulcers, and pressure ulcers, 60% were found to contain bacterial biofilms. The National Institutes of Health estimates that 80% of human infectious diseases are directly related to bacterial biofilm formation. Furthermore, it is widely recognized thatbacterial biofilms are highly resistant to antibiotic treatment. There is a growing body of evidence indicating that biofilm formation acts as a major impediment to the healing of cutaneous wounds. Accordingly, there is an urgent need for novel strategiesto disrupt biofilm formation in these wounds. The specific aims for this Fast-Track SBIR translational research proposal are designed to advance the development of ExpressGraftEnhance tissue, an antimicrobial living skin substitute created by Stratatech Corporation that has been shown to inhibit the growth of multidrug-resistant bacteria in an in vivo burn infection model (Mol Ther. 2009 Mar;17(3):562-9). Stratatech has established an interdisciplinary series of collaborative partnerships with industry, academia, and the U.S. armed forces to test ExpressGraftEnhance its effectiveness in preventing or disrupting biofilm formation by multidrug-resistant bacteria. Phase I milestones will 1) demonstrate that hCAP-18/LL-37 secreted by ExpressGraftEnhanceis efficacious against biofilm formation in vitro, 2) develop potency assays to monitor this bioactivity and 3) optimize ideal production and storage conditions for this living skin substitute tissue. The Phase II study will: 1) determine the efficacy ExpressGraftEnhance tissue in preventing or disrupting bacterial biofilm formation in vitro, 2) demonstrate the efficacy of ExpressGraftEnhance tissue against biofilm formation in both murine and porcine in vivo wound models of biofilm infection, 3) implementand qualify cGMP manufacturing processes and potency assays for ultimate clinical use and 4) demonstrate that late passage cells used to create ExpressGraftEnhance are karyotypically stable, non-tumorigenic, free of viral adventitious agents, and maintaintransgene stability and integrity. Stratatech's ultimate goal is to commercialize the ExpressGraftEnhance skin substitute for use in treating cutaneous wounds that are refractory to healing due to bacterial colonization and biofilm formation by wound pathogens. The studies of this proposal are designed to generate preclinical data that are required to support translation of the ExpressGraftEnhance technology into human clinical trials. Bacterial biofilms have become recently become recognized by the medical community as significant barriers to wound healing, and the National Institutes of Health estimates that 80% of human infectious diseases are directly related to bacterial biofilm formation yet no biological treatment options that specifically target biofilm infection have been developed and marketed. The goal of this translational Fast-Track SBIR proposal is to develop a series of collaborative partnerships to expedite the development of an innovative antimicrobial therapeutic aimed at accelerating the healing of wounds by preventing or disrupting wound biofilms formed by multidrug-resistant bacteria. The development of a cultured human skin substitute specifically engineered to disrupt biofilms would target the needs of the millions of patients afflicted with hard-to-heal skin wounds by both eliminating the impediment to healing while also promoting healing, reducing pain, and reducing the likelihood of other major complications.

Principal Investigator:

Allen R. Comer
608-441-2759
acomer@stratatechcorp.com

Business Contact:

Robert T. Barnard
608-441-2750
rbarnard@stratatechcorp.com
Small Business Information at Submission:

STRATATECH CORPORATION
505 S ROSA RD, STE 169 MADISON, WI -

EIN/Tax ID: 139202529
DUNS: N/A
Number of Employees: N/A
Woman-Owned: Yes
Minority-Owned: No
HUBZone-Owned: No