On June 1, 2023 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that it will present at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago, Illinois, June 2-6, 2023 (Press release, Decibel Therapeutics, JUN 1, 2023, View Source [SID1234632337]). The Company will present a poster summarizing data from the interim analysis of the Phase 1b clinical trial of DB-020, a novel, proprietary formulation of sodium thiosulfate (STS) designed to protect against hearing loss in cancer patients receiving cisplatin chemotherapy.
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"Hearing loss and tinnitus are significant, often debilitating sequelae of cisplatin-induced ototoxicity, for which there are currently no approved therapies. Cisplatin remains an important chemotherapy for the treatment of multiple cancer types, and DB-020 is designed to protect the patient against cisplatin-induced ototoxicity," said John Lee, Chief Development Officer of Decibel. "Data from the Phase 1b clinical trial demonstrate that treatment with DB-020 may result in a meaningful reduction in cisplatin-associated ototoxicity and support its continued development to potentially provide a therapy for an irreversible condition."
The Phase 1b clinical trial was a randomized, blinded study in which patients were dosed with DB-020 in one ear and placebo in the contralateral ear in conjunction with their prescribed infusion of cisplatin chemotherapy. Additional information about the clinical trial can be found at clinicaltrials.gov.
Decibel’s ASCO (Free ASCO Whitepaper) presentation includes additional ototoxicity measures, which are consistent with the previously reported topline interim analysis data showing that 87% of patients who experienced cisplatin-induced ototoxicity in their placebo-treated ear were protected from ototoxicity in their DB-020-treated ear. Treatment with DB-020 prior to cisplatin administration had no apparent effect on systemic cisplatin levels. DB-020 was generally well tolerated, with no serious adverse effects and no tympanic perforations.
Poster presentation details:
Title: A Phase 1 clinical trial of DB-020 tympanic injections administered prior to high dose cisplatin chemotherapy to reduce ototoxicity
Session and track: Head and Neck Cancer – Advanced/Metastatic Disease
Abstract number: 6043
Poster board number: 35
Date and time: Monday, June 5th, 1:15 p.m. CDT