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Targeting multiple signaling pathways for tinnitus prevention and treatment

Award Number: R44DC018759
ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2023

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Targeting multiple signaling pathways for tinnitus prevention and treatment - Subjective tinnitus is the perception of a phantom sound, which negatively impacts the quality of life for millions of people worldwide. Despite the great demand for remedy, there are no FDA-approved drugs to prevent or treat tinnitus. Possible causes of tinnitus are complicated. The current view is that hyperactivity in the central auditory nervous system contributes to the majority of tinnitus cases. This abnormal electrical activity, including an increase in delta-band activity, may be the direct result of an increase in T-type calcium channel activity. Other studies suggest that inflammatory responses within the brain may be involved in the development and persistence of tinnitus; therefore, drug candidates targeting both inflammatory and calcium signaling pathways may act synergistically to prevent and treat tinnitus. Tetrandrine (TET), an approved drug used in China, exhibits both anti-inflammatory and calcium channel-blocking properties. Using a new tinnitus detection method in mice, we have shown that both salicylate-induced and noise-induced tinnitus can be effectively treated by TET in a dose-dependent manner. Our hypothesis is that TET or its chemical analogs can be developed as drugs to prevent and treat tinnitus. In our proposed experiments, we have two parallel goals: (1) obtain investigational new drug (IND)-enabling toxicity and pharmacokinetics data for TET (Aim 1) and (2) optimize second-generation products with structure-activity relationship studies of TET and its chemical analogs (Aim 2). Successful accomplishment of Aim 1 will enable TET to advance into clinical development. In addition, the studies of Aim 2 will enable us to identify additional candidates in case TET fails at clinical stages. By targeting multiple cellular signaling pathways that impinge upon tinnitus, our study will open new areas for the treatment and prevention of tinnitus. The extensive body of data publicly available for TET and its analogs will help us significantly reduce development time and costs.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	GATEWAY BIOTECHNOLOGY, INC	1154 N WARSON RD	SAINT LOUIS	MO	63132	SAINT LOUIS	USA	Research Related to Deafness and Communication Disorders	000	2	1/16/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $1,207,345 )
2021	2021	GATEWAY BIOTECHNOLOGY INC.	4209 STATE ROUTE 44, SUITE D-148	ROOTSTOWN	OH	44272	PORTAGE	USA	Research Related to Deafness and Communication Disorders	001	2	6/15/2021	NON-COMPETING CONTINUATION	$1,207,345
2021	2020	GATEWAY BIOTECHNOLOGY INC.	4209 STATE ROUTE 44, SUITE D-148	ROOTSTOWN	OH	44272	PORTAGE	USA	Research Related to Deafness and Communication Disorders	000	1	6/8/2021	NEW	$0
														Subtotal = $1,207,345

Issue Date FY: 2020 ( Subtotal = $972,613 )
2020	2020	GATEWAY BIOTECHNOLOGY INC.	4209 STATE ROUTE 44, SUITE D-148	ROOTSTOWN	OH	44272	PORTAGE	USA	Research Related to Deafness and Communication Disorders	000	1	6/18/2020	NEW	$972,613
														Subtotal = $972,613

Grand Total All Awards = $2,179,958

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Targeting multiple signaling pathways for tinnitus prevention and treatment

Award Number: R44DC018759

ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2023

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