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Tiverton, RI, United States

CytoSolv, Inc. | Date: 2010-02-09

Pharmaceutical preparations for wounds.

Agency: NSF | Branch: Standard Grant | Program: | Phase: | Award Amount: 150.00K | Year: 2013

This Small Business Innovation Research (SBIR) Phase I Project continues the development of the choroid plexus (CP) growth factor cocktail for application to biologic hernia meshes to treat the challenging hernia repair market. CP factors represent a broad spectrum of potent biologic molecules that have demonstrated a benefit in the healing of splinted open wounds in diabetic mice, are neuroprotective, and can be harvested from cultured CP epithelium for at least a year. The current project focuses on formulating these factors into coatings that can be applied to porcine derived acellular dermal matrices in an attempt to provide modulation of the inflammatory cascade and subsequent improvement of engraftment. CP factors harvested from culture will be collected, purified, and concentrated into hydrogel coatings. Three markers of potency, VEGF, TIMP-2, and TGF-â, will be assessed by ELISA to characterize the raw materials, as well release profiles of various formulations. Using the rat midline abdominal defect model, coated mesh prototypes will be compared to commercially available products with a focus on histopathological characterization, gene expression within the graft, and mechanical integrity. The experimental design and selected endpoints are expected to provide the foundation for determining potential efficacy and subsequent product development pathways.

The broader impact/commercial potential of this project, if successful will address the need of, approximately 200,000-400,000 patients annually who are associated with impaired healing, poor engraftment of traditional hernia meshes, and recurrence rates as high as 65%. With very high rates of primary repair failure, as well as hernia developing from simple laparotomy, there is a significantly large unmet clinical need resulting in a market size of approximately $1.7B. A successful translation into the clinic will result in a product that improves hernia mesh engraftment by accelerating inflammation and promoting cell migration and extracellular matrix production. Such a product has the potential for an immediate impact in the clinic due to the rise in prevalence of patients with challenging hernia repairs, and lack of available efficacious therapies. The studies proposed here are preliminary steps toward commercialization, with the opportunity to capture a significant portion of the approximately $1.7B market, none of which is currently occupied by growth factor therapies. By demonstrating a therapeutic benefit, this work could be commercialized rapidly through an ongoing partnership to provide near-term benefit to patients with impaired healing.

Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 150.00K | Year: 2011

This Small Business Innovation Research (SBIR) Phase I project will focus on the development of a therapeutic gel containing the full complement of naturally occurring growth factors secreted by the choroid plexus (CP) for use in the active wound care market, including problematic superficial skin wounds such as diabetic ulcers. High doses of single recombinant factors have shown limited value in treating these wounds, with long-term side effects manifesting after cumulative exposure to milligram quantities. The unique technology that CytoSolv has developed employs multiple CP proteins to elicit a synergistic ?cocktail? effect that reduces the cumulative exposure to any one protein, while enhancing the pharmacologic impact by involving multiple regenerative pathways. The broader/commercial impacts of this research extend to tissue regeneration, and CytoSolv has initiated preclinical development to treat diabetic ulcers. These wounds are responsible for the majority of lower extremity amputations in the world, and are among the principal reasons for hospitalization of diabetic patients, accounting for 25% of all admissions in the US. Recently developed biologic therapies have not been widely accepted clinically due to inconsistent evidence of useful efficacy. As a result, the problem of managing complications of diabetic ulcers remains a major source of disability and cost to our health care system, with an active wound care market estimated at $20 billion in the US alone, and more than 115 companies delivering products for 5.7M patients. The goal of the current project is to develop an inexpensive, efficacious therapy based on the CP factor technology.

Tornoe J.,Nsgene Inc. | Torp M.,Nsgene Inc. | Jorgensen J.R.,Nsgene Inc. | Emerich D.F.,Nsgene Inc. | And 5 more authors.
Restorative Neurology and Neuroscience | Year: 2012

Purpose: Encapsulated cell (EC) biodelivery is a promising, clinically relevant technology platform to safely target the delivery of therapeutic proteins to the central nervous system. The purpose of this study was to evaluate EC biodelivery of the novel neurotrophic factor, Meteorin, to the striatum of rats and to investigate its neuroprotective effects against quinolinic acid (QA)-induced excitotoxicity. Methods: Meteorin-producing ARPE-19 cells were loaded into EC biodelivery devices and implanted into the striatum of rats. Two weeks after implantation, QA was injected into the ipsilateral striatum followed by assessment of neurological performance two and four weeks after QA administration. Results: Implant-delivered Meteorin effectively protected against QA-induced toxicity, as manifested by both near-normal neurological performance and reduction of brain cell death. Morphological analysis of the Meteorin-treated brains showed a markedly reduced striatal lesion size. The EC biodelivery devices produced stable or even increasing levels of Meteorin throughout the study over 6 weeks. Conclusions: Stereotactically implanted EC biodelivery devices releasing Meteorin could offer a feasible strategy in the treatment of neurological diseases with an excitotoxic component such as Huntington's disease. In a broader sense, the EC biodelivery technology is a promising therapeutic protein delivery platform for the treatment of a wide range of diseases of the central nervous system. © 2012 - IOS Press and the authors. All rights reserved. Source

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