GEL4MED, INC. — Department of Health and Human Services SBIR Phase I: NIAID

Description

The goal of this Phase I SBIR proposal is to test the feasibility of an inherently broad spectrum antibacterial tissue scaffolding matrix in preventing and eliminating biofilms while improving wound closure in chronic woundsDelayed non healing chronic wounds are responsible for approximatelyannual non traumatic lower limb amputations occurring in the United States aloneNearlyof all chronic wounds contain microbial biofilms which further complicate wound care by delaying healing and releasing inflammatory cytokinesIn additionthe emergence of multi drug resistant organismsMDROshave made the current topical and systemic antibiotics progressively less effective in combating chronic woundsHoweverthe biological scaffolds and matrices promote wound healingbut are ineffective at eliminating pathogens thereby complicating wound careThusthere are no current products to promote wound healing while eliminating and preventing biofilmsG Four proposed product caniprevent eliminate biofilms through a unique mechanism of action that is broad spectrum antibacterialandiipromote tissue regeneration by providing cell attachment sites within the scaffolding matrixUnlike any of the products currently used in the clinicsG Fdoes not rely on using any externally added antibioticsbut takes advantage of charge composition to exert toxicity against Grampositive andnegative bacteriaincluding antibiotic resistant strainsFurthermoreG Frelies only on sequence design for antimicrobial charge ratioand therefore is cell friendlynon inflammatory and nontoxic with a structure and pore size very similar to the native extracellular matrixECMHencein this feasibility study we propose three specific aimsSpecific AimEvaluate the efficacy of two different active formulations of PEP class gels against established Staphylococcus aureus and Pseudomonas aeruginosa biofilms in vitroSpecific AimDemonstrate Staphylococcus aureus and Pseudomonas aeruginosa bacterial and biofilm prevention reduction ex vivoSpecific AimDemonstrate Staphylococcus aureus and Pseudomonas aeruginosa bacterial and biofilm reduction in vivo using a chronic wound porcine modelIt is expected that the generated data will provide the necessary information for a phase II study to test polymicrobial biofilmsvalidate the product in larger statistically significant group of animals and enable commercialization of the proposed productPhase II studies will also enable GMP manufacturing and execute GLP studies in preparation for FDA submission The healing of chronic wounds is delayed by microbial biofilmsThe current treatment strategies for management of bioburden in chronic wounds is wound debridement followed by topical application of antibioticsboth of which are limited in their abilities to promote wound healingAlthough biological scaffolds and matrices provide support for cellular attachment and proliferation to promote wound healingthey cannot eliminate infectionsThuswe propose a novelsafeeasy to usemultifaceted solutionG Fto prevent and eliminate biofilms while promoting wound healing