Health
Fennec Pharmaceuticals Announces Positive Topline Results From Investigator-Initiated Clinical Study of PEDMARK® in Japan to Reduce Cisplatin-Induced Hearing Loss
– Study, Which Enrolled 27 Patients, Met Primary Endpoint with a Significant Reduction in Hearing Loss in 3-18 Year Old Patients who Received PEDMARK® when Compared with Historically Reported Rates of Hearing Loss in Patients Receiving Cisplatin Alone (16-24% versus 56-63%, Respectively) – – PEDMARK® Showed No Interference with Cisplatin Antitumor Activity as Evidenced by an Approximate 95% Clinical Response Rate – – The Company Plans to Pursue Registration and is Exploring Partnering or Licensi
About this update from Fennec Pharmaceuticals Inc.
[{"type":"image","alt":"Fennec Pharmaceuticals Inc.","displaySize":"","headline":null,"caption":"Fennec Pharmaceuticals Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":121,"height":66,"url":"https://media.zenfs.com/en/globenewswire.com/e01604120df1fa3b9ec5192e4215917f"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/UkeWnOD1xSZWjTITE4vjkA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIxMDtoPTExNTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/e01604120df1fa3b9ec5192e4215917f","width":121,"height":66}},"lazy":false},{"type":"text","content":"– Study, Which Enrolled 27 Patients, Met Primary Endpoint with a Significant Reduction in Hearing Loss in 3-18 Year Old Patients who Received PEDMARK® when Compared with Historically Reported Rates of Hearing Loss in Patients Receiving Cisplatin Alone (16-24% versus 56-63%, Respectively) –","length":290,"tagName":"p"},{"type":"text","content":"– PEDMARK® Showed No Interference with Cisplatin Antitumor Activity as Evidenced by an Approximate 95% Clinical Response Rate –","length":127,"tagName":"p"},{"type":"text","content":"– The Company Plans to Pursue Registration and is Exploring Partnering or Licensing Opportunities for PEDMARK® in Japan Based Upon These Results –","length":146,"tagName":"p"},{"type":"text","content":"RESEARCH TRIANGLE PARK, N.C., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today announced positive topline results from the investigator-initiated Phase 2/3 STS-J01 clinical trial evaluating PEDMARK® (sodium thiosulfate injection) for the reduction of cisplatin-induced ototoxicity in pediatric and adolescent and young adult (AYA) patients with non-metastatic solid tumors in Japan. PEDMARK® is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors.","length":723,"tagName":"p"},{"type":"text","content":"The study, which enrolled 27 patients in the primary cohort (patients aged 3-18 years) and 6 in exploratory cohorts and examined the addition of PEDMARK® administered six hours after cisplatin. The primary endpoint of the study was met and the data showed that 24% and 16% of evaluable patients who were treated with...