SBIR Phase I: A Novel Approach to Cholesteatoma Treatment

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This Small Business Innovation Research (SBIR) Phase I Project will develop the first non-surgical cure for cholesteatoma. Cholesteatomas are congenital or acquired lesions of the temporal bone that primarily affect the middle ear and mastoid. These lesions are highly destructive and can cause deafness, dizziness, facial nerve paralysis, brain abscess, meningitis, and death. Cholesteatomas cause significant morbidity and mortality worldwide. Currently, there is no cure for cholesteatoma but a costly surgery outside the reach of most of the developing world population. The project is aimed at redirecting the cytotoxic arsenal of a natural opportunistic pathogen of the human ear to destroy the disease. The cytotoxic effects will be mediated by the bacterial injectosome, a natural structure that can translocate toxins from the bacterium to the attached host cells. At any time treatment can be interrupted by treatment with standard antibiotics, since the technology will be sensitive to multiple antibiotics by genetic design. The broader impact of this project applies to a large portion of the world population that suffers from morbidity and mortality related to CHST lacks access to adequate treatment of this neoplasm. In the US, cholesteatoma is especially a challenge for rural and indigent regions. In developing countries the incidence of these lesions is much larger, since it is related to defective access to advance medical care. The ultimate end result of our work will be a novel therapy for cholesteatoma that will replace a costly surgery with an out-patient, minimally invasive and cost competitive treatment. There is an urgent need for new, simple, and affordable approaches in cholesteatoma treatment. The proposed experiments will provide a first step in the development of a novel treatment using bacterial robots that will significantly improve cholesteatoma management, and ultimately could provide a complete cure at a fraction of the current cost. If successful, this approach could be extended and applied to other malignant epithelial growths.