GATEWAY BIOTECHNOLOGY, INC. — Department of Health and Human Services STTR Phase I: NIDCD

Description

PROJECT SUMMARY The most common occupational and environmental hazard in this country is noise Itandapos s not surprising then that noise induced hearing loss NIHL is the second most common form of sensorineural hearing deficit behind only age related hearing loss presbycusis Although therapeutics that target the free radical pathway have shown promise for reducing NIHL there are no effective nutraceuticals or approved medications for NIHL Development of an efficacious treatment has been hampered by the complex array of cellular and molecular pathways involved in NIHL Our preliminary studies have shown that the Chinese herb Stephania tetrandra and its main extract tetrandrine TET can effectively protect against NIHL in mice Clinical use of this herb has exhibited an excellent long term safety profile Moreover TET possesses strong antioxidant and anti inflammatory properties and can also block calcium channels thus targeting three main signaling pathways that underlie NIHL Consistent with the funding priorities at National Center for Complementary and Integrative Health in this Phase I application we will determine the median effective dose ED for this herb extract to prevent Aim and treat Aim NIHL in rats using a long noise exposure model hours per day similar to most industrial working environments The innovative aspects of our approach are developing a nutraceutical against NIHL thus breaking a major access barrier for customers who are more likely to visit audiologists for hearing treatment testing in a rat model with cumulative noise exposure similar to that encountered by factory workers selecting an herb with well characterized pharmacological properties and a long safety history of clinical applications and targeting multiple signaling pathways that underlie NIHL If the outcome of this study is successful we will then obtain institutional review board IRB approval to conduct SBIR Phase II studies in humans of this nutraceutical against NIHL The goal of our program is to bring this nutraceutical to market for use in the prevention and treatment of NIHL If this approach is successful similar nutraceuticals will be evaluated for potential prevention of presbycusis PROJECT NARRATIVE The work in this proposal focuses on the development of effective interventions for noise induced hearing loss More than million people in the United States are exposed to hazardous levels of noise on a regular basis This proposal will develop a new nutraceutical to prevent and treat NIHL and if successful provide sufficient preclinical data for future clinical studies to ameliorate NIHL