Winston-Salem, NC, United States
Winston-Salem, NC, United States
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Patent
KeraNetics, LLC | Date: 2015-05-05

The invention provides white keratin protein compositions and methods of making and using white keratin protein compositions.


Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase II | Award Amount: 751.60K | Year: 2013

Improvements in body armor, availability of equipment, and decreased patient transport times have dramatically improved Soldiers survival of combat injuries. Data suggests that future conflicts will require more aggressive wound management at the point of injury to deal with more complex wounds, particularly with respect to infection control. There is a significant need to develop and translate platform technologies that can address these injuries while providing infection control. This proposal seeks to build on Phase I work using a flowable keratin based carrier system for slow-release of antibiotics. Data from our Phase I project demonstrated that flowable keratin biomaterials loaded with antibiotics (KeraStat ICG) supported keratinocyte and fibroblast proliferation while preventing colony formation of Gram-positive, Gram-negative and anaerobic bacteria. This Phase II project seeks to expand these findings into in vivo models of infected excisional and burn wounds, comparing our KeraStat ICG formulation to the standard of care for these injuries. Additionally, we will conduct safety and stability testing necessary for filing this combination product with the FDA.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase I | Award Amount: 149.83K | Year: 2013

This Phase I project is relevant to the ultimate goals of this program announcement given the prevalence of the IED which often creates complex burn wounds on the face and skin that often form hypertrophic scars that often contract over time. Burn wound healing is a complex process that includes phases of inflammation, granulation tissue formation, re-epithelialization, and, finally, remodeling. Our proposed solution intends to intervene during the wound healing and remodeling phase to prevent hypertrophic scars from forming, thereby preventing scar contracture. In this initial proof of concept study, a keratin burn product KeraStat Burn Gel and a keratin + halofuginone product (Halogel, halofuginone is a Type I collagen synthesis inhibitor) will be assessed for contraction prevention by a standard commercially available fibroblast contraction assay. Additionally inflammatory and matrix gene expression will be examined by RT-PCR array in fibroblasts and keratinocytes after keratin and halofuginone exposure. Together these data will form the basis for a Phase II large and small animal efficacy study in models of burn scar contracture.


Patent
KeraNetics, LLC | Date: 2014-03-17

Described herein are compositions of keratin-based biomaterials together with halofuginone and methods of using thereof


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 1000.00K | Year: 2012

Skeletal muscle injury is a significant challenge to warfighters due to the severity of the injuries often caused by Improvised Explosive Devices. Currently, there are few viable clinical treatment options for these types of injuries. Keratin hydrogels offer a solution to these challenges as carriers of cells and growth factors. Human epithelial keratins are the major structural proteins in cells and form a cytoplasmic network of intermediate filaments. Human hair keratins are genetically similar to epithelial keratins and their intrinsic characteristics make them unique candidates for biomaterial-based carriers of growth factors and cells. In the Phase I project, we showed that keratin hydrogels provide sustained release of growth factors and maintain cell viability in vivo. This Phase II proposal will build on these findings and move toward a product that facilitates skeletal muscle regeneration. The Phase II objectives are to optimize formulations of keratin for delivery of cells and supporting growth factors (FGF and IGF-1), to test the safety and immunogenicity of these formulations, and to assess the functional muscle recovery in two rodent models of muscle loss. Completion of the Phase II objectives will yield a keratin hydrogel formulation optimized for in vivo regeneration of injured skeletal muscle.


Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase I | Award Amount: 99.94K | Year: 2014

This Phase I project is relevant to the goals of this program announcement given the prevalence of complex burn wounds that cause both acute and chronic pain. The current solution to burn-related pain is the administration of systemic opioid pain drugs, which have significant side effects and are highly addictive. Recently, it has been shown that localized delivery of opioids can alleviate pain without the associated risks of systemic delivery; however, no reliable carrier has been identified thus far. An ideal carrier would both act as a wound dressing and provide sustained release of the analgesic. A solution to this problem is to use a keratin hydrogel burn wound dressing (KeraStat) that has been shown to be an effective drug delivery vehicle for the topical delivery of antibiotics and other drugs. This Phase I project seeks to test the feasibility of using KeraStat to provide local, topical extended release of commonly used pain drugs. The studies proposed here will test the release kinetics of several formulations of analgesic-loaded KeraStat. The most promising formulations will then be tested in a mouse paw pain model for pilot efficacy. Together these data, along with data from rheometry performed on the loaded hydrogels, will form the basis for Phase II small and large animal efficacy studies in models relevant to burn pain.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase I | Award Amount: 149.99K | Year: 2014

With the advent of improved body armor and vehicles and the enemy"s use of the improved explosion device (IED) in the most recent conflicts, blast injuries and related burns to the face have become more and more common among our Wounded Warriors. Pathological scarring, which often results in contracture, tends to be more prevalent in these burn cases due to the traumatic nature of the IED injury. The specialized care, rehabilitation, and reconstructive surgery required for these injuries results in significant degradation of quality of life for facial burn victims. The aim of this proposed project is to conduct a proof of concept for an innovative 3D printed halofuginone eluding keratin-based wound dressing that could potentially improve healing rates and reduce scarring and contracture in our burned Wounded Warriors. The proposed dressing will be formulated and tested for mechanical properties and drug delivery capabilities. It will then be tested in vitro for treatment of wound contracture. In the potential Phase II follow-on project, a full prototype of the dressing would be constructed, and efficacy would be tested in a porcine burn model.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 999.30K | Year: 2014

No currently available burn product has shown efficacy in substantially decreasing wound healing time and preventing scar formation. The goals of this Phase II proposal are to expand on the results obtained in the Phase I study that showed that (1) halofuginone inhibited collagen-mediated contracture in dermal fibroblasts and (2) the presence of the keratin in the KeraStat burn product results in an attenuation of the cellular injury response following UVB irradiation. The proposed Phase II project will test two potential solutions (KeraStat and Halogel) to determine their efficacy in reducing time to wound closure and decreasing scarring in a porcine burn healing and scarring model. Following this in vivo efficacy testing, we will further expand to test the efficacy of KeraStat for reducing time to wound closure and for scar prevention in an investigator-initiated 60 patient human clinical trial in partial thickness burn patients. Together, these studies will allow KeraNetics to market and sell the KeraStat product to both the Department of Defense and to civilian burn centers to treat patients and Soldiers with debilitating burn wounds and scars.


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 1000.00K | Year: 2015

Currently, no commercial products exist for the repair of large injuries to muscle, particularly volumetric muscle loss (VML). In Phase I of this project, data demonstrated that keratin biomaterials can provide temporal release of growth factors while maintaining cell viability in vitro and in vivo. In Phase II, the biomaterial formulation was optimized for spatio-


Grant
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 999.66K | Year: 2015

Burn injuries, particularly those to the face, present a number of functional and psychological challenges that arise from scarring and related contracture. A major goal of trauma and burn surgeons is to prevent scarring and improve grafting technologies given the complexity of facial topography. This project seeks to optimize and finalize a prototype of a 3D printed keratin facemask capable of delivering drugs capable of inhibiting scar formation. This will be accomplished by first optimizing the formulation through a series of in vitro tests, screening optimized formulations in a small thermal burn wound model in pigs, and confirming efficacy of the selected construct in a large thermal burn wound model in pigs. Additionally, a facemask prototype will be printed, and storage parameters will be determined. The resulting construct will be able to act as a long-term primary burn wound dressing that delivers a drug to prevent scarring as it naturally degrades, reducing the need for full, painful dressing changes and the risk of scarring and contracture in our Wounded Warriors.

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