SCARLESS LABORATORIES INC — Department of Health and Human Services SBIR Phase II: NIAMS

Description

DESCRIPTION provided by applicant Cutaneous fibrosis scarring affects up to million patients per year as a result of million elective operations and million operations after trauma Besides concerns of cosmesis scarring can have significant functional sequelae Overall scar prevention strategies for skin are minimally effective Currently available techniques focus on reducing the appearance of already formed scars e g silicone sheeting topical ointments lasers Other scar reduction strategies that target the scar formation process such as steroids and radiation can have undesirable side effects With these substantial limitations there remains a pressing need for the development of alternative therapies for the prevention of cutaneous scarring Through a sustained year research effort examining models of fetal wound healing we have identified fibromodulin FMOD as a novel molecule required for fetal scarless skin repair FMOD protein decreases scarring and improves extracellular matrix ECM organization in adult wounds These findings have been confirmed across multiple mammalian species As a technological innovation we have developed a amino acid FMOD peptide sequence F C which can undergo rapid and inexpensive production and is similar to the amino acid full FMOD protein in its anti fibrotic effects Because porcine skin is the closest animal skin equivalent to that of humans and is the Food and Drug Administration FDA preferred model for testing wound healing products we have established the optimal dose and regimen of F C F C OPT that effectively improves gross visual appearance reduces scar size and maintains wound tensile in a Yorkshire pig primary wound closure model simulating human scar revision surgery In addition we have confirmed that F C OPT has the same effects in a red Duroc pig model simulating human hypertrophic scarring and we are ready to apply it to Investigational New Drug IND enabling studies Moreover we have demonstrated that F C does not have in vivo adverse local effects in mice rats and pigs notably up to mg ml with ml was applied for cm mg cm of wound in the porcine models Furthermore we have also proved that no significant systemic toxicity is observed in rats with up to mg kg F C which can be converted to a mg kg human equivalent dose HED for a kg male this dose can be translated to approximately a mg total dose enough to treat a cm linear scar This far exceeds the size of typical scars and the anticipated amount of F C required for treatment e g mg per every linear cm of scar Thus we have accomplished all aims proposed in our previous SHIFT SBIR Phase I award R AR The goal of the current SBIR Phase II application is to perform critical IND enabling studies for first in man F C clinical trials an to allow bench to bedside translation of FMOD peptide based therapy to prophylactically reduce cutaneous scar formation PUBLIC HEALTH RELEVANCE Costs of excessive cutaneous scarring and other wound healing complications approach billion dollars per annum and up to million patients acquire scars per year In addition pathologic scarring fibrosis affects numerous organ systems in fatal disease processes including the liver lung and kidney This project seeks to develop an effective novel peptide based treatment to reduce scarring and to improve the quality of life for patients suffering from excessive scar formation