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Developing a Nutraceutical Product against Noise Induce Hearing Loss

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DC016842-01
Agency Tracking Number: R41DC016842
Amount: $224,700.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIDCD
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-21
Award End Date (Contract End Date): 2018-09-20
Small Business Information
Saint Louis, MO 63130-4309
United States
DUNS: 968854815
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (314) 620-5737
Business Contact
Phone: (314) 620-5737
Research Institution
BOX 400, 4455 GENESEE ST
BUFFALO, NY 14225-1955
United States

 Domestic nonprofit research organization

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

* Information listed above is at the time of submission. *

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