TRIM-EDICINE INC — Department of Health and Human Services SBIR Phase I: 300

Description

Project Summary This Phase I SBIR proposal targets the development of recombinant human MG rhMG a novel tissue repair protein as a topical therapeutic candidate to facilitate healing of chronic wounds Wound care represents a challenging problem to the public health as no effective treatments for chronic non healing wounds are available MG is an essential component of the cell membrane repair machinery that protects against tissue injuries Research and development efforts at TRIM edicine a university spin off biotechnology company have established that rhMG protein has great potential in facilitation of wound healing and reduction of scar formation targeting multiple cellular processes The chemistry manufacture and control CMC process for scale up production of rhMG has been developed Preliminary toxicological studies in rodent and dog models support the safety for rhMG in topical and intravenous applications There is extensive evidence to support the efficacy for rhMG in treatment of cutaneous wounds in rodent and rabbit models Based on these studies TRIM edicine initiated a pre IND meeting with the FDA and obtained guidance from the Agency for developing rhMG as a topical agent to facilitate healing of chronic wounds The goal of this SBIR project is to conduct the required pre clinical studies testing the safety and efficacy of rhMG as a topical therapy toward evaluating this agent in human subjects with wound healing problems Studies proposed in this application will involve joint development efforts between TRIM edicine and Wound Care Center at The Ohio State University Specifically we propose to produce sufficient rhMG proteins to support the IND enabling topical formulation for rhMG with adequate shelf life and activity Aim and then test the lead prototype formulation in a porcine model of chronic ischemic wounds to evaluate the safety and efficacy of rhMG as a topical therapy Aim Fulfillment of these studies is pivotal for our future development effort with testing rhMG in human clinical trials to facilitate healing of chronic wounds NARRATIVE Development of a therapeutic approach to facilitate healing of chronic wound represents an important area of biomedical and clinical research The lead molecule for this application is MG a novel tissue repair gene Fulfillment of the studies proposed here will aid the pre clinical and clinical development of this molecule a potential viable option for treating non healing wounds We have clearly defined the measurable goals that we plan to achieve in this grant proposal