This Small Business Innovation Research (SBIR) Phase I project aims to demonstrate proof-of-concept for a unique low toxicity Type I interferon in augmenting the wound healing process caused by thermal burns. Wound healing can be a long and painful process, especially for burn patients who, depending on the total body burn size and skin loss, must endure months of skin grafting, the possibility of life-threatening infections with no guarantees of success, as well as altered skin appearance, reduced skin function and scar tissue formation. The effects of this novel interferon on wound healing will be investigated using the following three specific aims: 1) prove the efficacy of the interferon in augmenting the wound healing of burns; 2) demonstrate the mechanism of action of the interferon by investigating the underlying molecular processes; and 3) prove that the interferon has low toxicity.
The broader commercial impacts of this research are tremendous. Every year, over 2 million Americans require treatment for burns. About 100,000 of these burn victims are hospitalized and about 11,000 die. The 2009 US National Burn Repository reported that the mean hospital charge for each patient with acute burn injuries was $53,465. A definite unmet need still exists to develop novel therapies that result in decreasing healing times, minimizing complications and reducing subsequent healthcare cost savings. This novel interferon is expected to accelerate the wound healing process and minimize scar formation which will have a profound positive impact on the quality of life for the patients and reduce healthcare costs.
The Phase I objectives were designed to determine the technical and commercial feasibility of a biomolecule as topical drug to augment the wound healing process. An in vitro full thickness skin model was used to assess the therapeutic effects of the topically administered drug on burn wounds. The skin model consists of normal, human epidermal keratinocytes and normal, human derived dermal fibroblasts cultured to form a multilayered, highly differentiated model of human dermis and epidermis. Results from this study show molecular and histological evidence which demonstrate the potential of the drug to augment the wound healing process. Drug-treated skin samples cultured for 1 to 5 days also show excellent viability. The broader commercial impacts of this research are tremendous. Every year, over 2 million Americans require treatment for burns. About 100,000 of these burn victims are hospitalized and about 11,000 die. Depending on their total body burn size and skin loss, burn victims who survive endure months of skin grafting with no guarantees of success, as well as, a high probability of altered skin appearance, reduced skin function and scar tissue formation. The 2009 US National Burn Repository reported that the mean hospital charge for each patient with acute burn injuries was $53,465. A definite unmet need still exists to develop novel therapies that result in decreasing healing time, minimizing complications and reducing subsequent healthcare cost savings.
