The wound repair process in skin is initiated immediately after an injury and induces a cascade of events including inflammation, proliferation, and scar production/tissue remodeling. 1 of the common complications of wound healing is excessive scarring, leading to undesirable changes in skin mechanical function, as well as cosmetic disfiguration. The adverse changes in skin structure and function resulting from scar formation affects over 35 million US citizens a year resulting in costs of more than $7 billion dollars. FirstString Research, LLC (FSR) is a biotech startup company located in Charleston, South Carolina. The founders of FSR, Drs. Robert Gourdie and Gautam Ghatnekar are co inventors of a novel bioengineered peptide that shows promise in enhancing healing and normalizing skin appearance and mechanical function following injury. Recent data indicates that the gap junction protein Connexin43 (Cx43) has key, though ill- defined roles in orchestrating wound healing in skin. The FSR peptide is based on a carboxy-terminal fragment of Cx43 and has been rationally designed to interfere with the binding of Cx43-interacting proteins. Preliminary data in mouse indicate that FSR's peptide has beneficial effects in multiple phases of healing following mechanical wounding of skin, possibly via amplifying an endogenous healing mechanism. The peptide effects include reduction in initial inflammatory response, acceleration of healing rate and reduction in scar tissue formation. Moreover, in addition to improving cosmetic appearance, FSR's peptide promotes regeneration and normalization of the mechanical properties of wounded skin. In Phase I of this STTR, a """"""""proof of concept"""""""" and safety study of our peptide in a pig model of wound healing will be undertaken at MUSC under a sub-contract from FSR to determine whether the clinically beneficial effects observed in mouse hold up in an animal model with healing mechanisms more comparable to humans. Pending successful completion of Phase I, our plan for a future Phase II, would be to undertake GLP studies in pigs as a pre-requisite for phase I clinical trials. It is FSR's overall objective to develop its peptide into a pharmaceutically acceptable topical agent for application to surgical and non-surgical skin wounds in humans. ? ? ?
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