Fennec Pharmaceuticals Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits
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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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Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
Exhibit No. | Description |
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Exhibit 99.1 | |
Exhibit 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| FENNEC PHARMACEUTICALS INC. |
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Date December 9, 2025 | By: | /s/ Robert Andrade |
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| Robert Andrade Chief Financial Officer |