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GATEWAY BIOTECHNOLOGY, INC
ROOTSTOWN, OH, 44272
UnclaimedClaim this profile (free)
Prime contracting experience
1 record from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Prime | Department of Defense Defense Health Agency | MEDICAL RESEARCH AND DEVELOPMENT CONTRACT DHA SBIR PH II, PROPOSAL NO. H2S-0048, TITLED: "GW-TT2, A NEW DRUG PRODUCT FOR TINNITUS" | — | $1,949,999 | Apr 23, 2026 | Sep 18, 2023 – Aug 23, 2027 |
Contract vehicles are shown only when present in the source record. Linked award numbers and vehicles open the authoritative record on USAspending.gov.
Subcontracting experience
8 records from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Subcontractor | Department of Defense | SECTION C - DESCRIPTIONS AND SPECIFICATIONS
STATEMENT OF WORK
SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S.
SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D.
SITE 3: BIOGENERATOR LABS, SUITE 232, 4340 DUNCAN AVE. , ST. LOUIS, MO 63110 COORDINATOR: JIANXIN BAO, PH.D.
SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080
COORDINATOR: COLLEEN G. LE PRELL, PH.D.
ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE.
STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS).
STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS.
STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL.
TASKS TIMELINE SITES
STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD
TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD
REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM
RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD
RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI
ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD
RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM
FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI
COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD
MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM
PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD
OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM
STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD
PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM,
PHARM-OLAM, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD
RECRUIT AND TEST 60 SUBJECTS (50% OF PLAN WU-20-127-MOD-5 Parent award context Parent award agency: Department of Defense · Defense Health Agency Parent award NAICS: 541715 Parent award performance state: MO Parent award description: REQUIREMENT: PHARMACEUTICAL INTERVENTIONS FOR NOISE INDUCED HEARING LOSS ACUTE EXPOSURE TREATMENT (PINIHL AET) ACTION: AWARD. View parent award on USAspending | — | -$1,183,152 | Oct 31, 2023 | — – — |
| Subcontractor | Department of Defense | SECTION C - DESCRIPTIONS AND SPECIFICATIONS
STATEMENT OF WORK
SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S.
SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D.
SITE 3: BIOGENERATOR LABS, SUITE 232, 4340 DUNCAN AVE. , ST. LOUIS, MO 63110 COORDINATOR: JIANXIN BAO, PH.D.
SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080
COORDINATOR: COLLEEN G. LE PRELL, PH.D.
ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE.
STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS).
STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS.
STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL.
TASKS TIMELINE SITES
STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD
TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD
REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM
RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD
RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI
ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD
RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM
FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI
COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD
MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM
PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD
OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM
STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD
PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM,
PHARM-OLAM, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD
RECRUIT AND TEST 60 SUBJECTS (50% OF PLAN WU-20-127-MOD-4 Parent award context Parent award agency: Department of Defense · Defense Health Agency Parent award NAICS: 541715 Parent award performance state: MO Parent award description: REQUIREMENT: PHARMACEUTICAL INTERVENTIONS FOR NOISE INDUCED HEARING LOSS ACUTE EXPOSURE TREATMENT (PINIHL AET) ACTION: AWARD. View parent award on USAspending | — | $1,093,989 | Jan 27, 2023 | — – — |
| Subcontractor | Department of Defense | SECTION C - DESCRIPTIONS AND SPECIFICATIONS
STATEMENT OF WORK
SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S.
SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D.
SITE 3: BIOGENERATOR LABS, SUITE 232, 4340 DUNCAN AVE. , ST. LOUIS, MO 63110 COORDINATOR: JIANXIN BAO, PH.D.
SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080
COORDINATOR: COLLEEN G. LE PRELL, PH.D.
ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE.
STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS).
STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS.
STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL.
TASKS TIMELINE SITES
STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD
TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD
REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM
RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD
RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI
ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD
RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM
FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI
COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD
MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM
PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD
OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM
STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD
PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM,
PHARM-OLAM, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD
RECRUIT AND TEST 60 SUBJECTS (50% OF PLAN WU-20-127-MOD-4 Parent award context Parent award agency: Department of Defense · Defense Health Agency Parent award NAICS: 541715 Parent award performance state: MO Parent award description: REQUIREMENT: PHARMACEUTICAL INTERVENTIONS FOR NOISE INDUCED HEARING LOSS ACUTE EXPOSURE TREATMENT (PINIHL AET) ACTION: AWARD. View parent award on USAspending | — | $1,093,989 | Jan 27, 2023 | — – — |
| Subcontractor | Department of Defense | SECTION C - DESCRIPTIONS AND SPECIFICATIONS
STATEMENT OF WORK
SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S.
SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D.
SITE 3: BIOGENERATOR LABS, SUITE 232, 4340 DUNCAN AVE. , ST. LOUIS, MO 63110 COORDINATOR: JIANXIN BAO, PH.D.
SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080
COORDINATOR: COLLEEN G. LE PRELL, PH.D.
ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE.
STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS).
STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS.
STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL.
TASKS TIMELINE SITES
STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD
TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD
REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM
RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD
RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI
ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD
RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM
FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI
COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD
MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM
PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD
OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM
STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD
PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM,
PHARM-OLAM, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD
RECRUIT AND TEST 60 SUBJECTS (50% OF PLAN WU-20-127-MOD-4 Parent award context Parent award agency: Department of Defense · Defense Health Agency Parent award NAICS: 541715 Parent award performance state: MO Parent award description: REQUIREMENT: PHARMACEUTICAL INTERVENTIONS FOR NOISE INDUCED HEARING LOSS ACUTE EXPOSURE TREATMENT (PINIHL AET) ACTION: AWARD. View parent award on USAspending | — | $1,093,989 | Jan 27, 2023 | — – — |
| Subcontractor | Department of Defense | SECTION C - DESCRIPTIONS AND SPECIFICATIONS
STATEMENT OF WORK
SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S.
SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D.
SITE 3: BIOGENERATOR LABS, SUITE 232, 4340 DUNCAN AVE. , ST. LOUIS, MO 63110 COORDINATOR: JIANXIN BAO, PH.D.
SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080
COORDINATOR: COLLEEN G. LE PRELL, PH.D.
ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE.
STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS).
STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS.
STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL.
TASKS TIMELINE SITES
STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD
TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD
REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM
RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD
RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI
ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD
RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM
FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI
COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD
MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM
PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD
OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM
STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD
PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM,
PHARM-OLAM, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD
RECRUIT AND TEST 60 SUBJECTS (50% OF PLAN WU-20-127-MOD-3 Parent award context Parent award agency: Department of Defense · Defense Health Agency Parent award NAICS: 541715 Parent award performance state: MO Parent award description: REQUIREMENT: PHARMACEUTICAL INTERVENTIONS FOR NOISE INDUCED HEARING LOSS ACUTE EXPOSURE TREATMENT (PINIHL AET) ACTION: AWARD. View parent award on USAspending | — | $396,195 | Feb 9, 2022 | — – — |
| Subcontractor | Department of Defense | SECTION C - DESCRIPTIONS AND SPECIFICATIONS
STATEMENT OF WORK
SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S.
SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D.
SITE 3: BIOGENERATOR LABS, SUITE 232, 4340 DUNCAN AVE. , ST. LOUIS, MO 63110 COORDINATOR: JIANXIN BAO, PH.D.
SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080
COORDINATOR: COLLEEN G. LE PRELL, PH.D.
ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE.
STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS).
STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS.
STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL.
TASKS TIMELINE SITES
STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD
TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD
REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM
RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD
RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI
ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD
RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM
FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI
COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD
MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM
PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD
OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM
STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD
PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM,
PHARM-OLAM, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD
RECRUIT AND TEST 60 SUBJECTS (50% OF PLAN WU-20-127-MOD-3 Parent award context Parent award agency: Department of Defense · Defense Health Agency Parent award NAICS: 541715 Parent award performance state: MO Parent award description: REQUIREMENT: PHARMACEUTICAL INTERVENTIONS FOR NOISE INDUCED HEARING LOSS ACUTE EXPOSURE TREATMENT (PINIHL AET) ACTION: AWARD. View parent award on USAspending | — | $396,195 | Feb 9, 2022 | — – — |
| Subcontractor | Department of Defense | SECTION C - DESCRIPTIONS AND SPECIFICATIONS
STATEMENT OF WORK
SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S.
SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D.
SITE 3: BIOGENERATOR LABS, SUITE 232, 4340 DUNCAN AVE. , ST. LOUIS, MO 63110 COORDINATOR: JIANXIN BAO, PH.D.
SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080
COORDINATOR: COLLEEN G. LE PRELL, PH.D.
ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE.
STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS).
STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS.
STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL.
TASKS TIMELINE SITES
STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD
TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD
REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM
RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD
RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI
ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD
RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM
FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI
COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD
MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM
PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD
OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM
STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD
PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM,
PHARM-OLAM, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD
RECRUIT AND TEST 60 SUBJECTS (50% OF PLAN WU-20-127-MOD-3 Parent award context Parent award agency: Department of Defense · Defense Health Agency Parent award NAICS: 541715 Parent award performance state: MO Parent award description: REQUIREMENT: PHARMACEUTICAL INTERVENTIONS FOR NOISE INDUCED HEARING LOSS ACUTE EXPOSURE TREATMENT (PINIHL AET) ACTION: AWARD. View parent award on USAspending | — | $396,195 | Feb 9, 2022 | — – — |
| Subcontractor | Department of Defense | SECTION C - DESCRIPTIONS AND SPECIFICATIONS
STATEMENT OF WORK
SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S.
SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D.
SITE 3: BIOGENERATOR LABS, SUITE 232, 4340 DUNCAN AVE. , ST. LOUIS, MO 63110 COORDINATOR: JIANXIN BAO, PH.D.
SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080
COORDINATOR: COLLEEN G. LE PRELL, PH.D.
ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE.
STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS).
STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS.
STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL.
TASKS TIMELINE SITES
STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD
TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD
REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM
RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD
RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM
FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI
ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD
RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM
FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI
COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD
MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM
PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD
OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM
STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD
PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM,
PHARM-OLAM, UA, UTD
FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD
RECRUIT AND TEST 60 SUBJECTS (50% OF PLAN WU-20-127-MOD-3 Parent award context Parent award agency: Department of Defense · Defense Health Agency Parent award NAICS: 541715 Parent award performance state: MO Parent award description: REQUIREMENT: PHARMACEUTICAL INTERVENTIONS FOR NOISE INDUCED HEARING LOSS ACUTE EXPOSURE TREATMENT (PINIHL AET) ACTION: AWARD. View parent award on USAspending | — | $396,195 | Feb 9, 2022 | — – — |
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