Company: FENC
Filing Date: 2025-12-09
Form Type: 8-K
Source: 0001104659-25-119654
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Company: FENNEC PHARMACEUTICALS INC.
Filing Date: 2025-12-09
Form: 8-K
Item: Item 8.01
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Item 8.01.      Other Events.  

On December 9, 2025, Fennec Pharmaceuticals Inc. (the “ Company”) announced the planned initiation of an investigator-sponsored clinical study (“ IST”) to be conducted by City of Hope, a U. S. cancer research and treatment organization, to evaluate PEDMARK®(sodium thiosulfate injection) for the prevention of cisplatin-induced ototoxicity in adult men with stage II-III metastatic testicular germ cell tumors.

The Phase I study (ClinicalTrials. gov Identifier: NCT07218913) is titled“ Testing the Addition of PEDMARK® to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III Metastatic Testicular Germ Cell Tumors.”The study is being conducted at City of Hope in Duarte, California, with Alexander Chehrazi-Raffle, M. D., serving as principal investigator. The study will evaluate whether the addition of PEDMARK®to standard cisplatin-based chemotherapy reduces drug-induced ear damage (ototoxicity) in men with metastatic testicular germ cell tumors.

PEDMARK®is currently approved in the United States for pediatric patients one month of age and older with localized, non-metastatic solid tumors and has received a Category 2A recommendation from the National Comprehensive Cancer Network for use in adolescent and young adult patients.

The Company also disclosed that multiple additional investigator-initiated studies have been submitted and are currently under internal review, with others in advanced contracting or evaluation stages.

A copy of the Company’s press release announcing the investigator-sponsored study is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

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