Fennec Pharmaceuticals Inc. (FENC,FRX.TO) announced Tuesday positive topline results from the investigator-initiated Phase 2/3 STS-J01 clinical trial evaluating PEDMARK (sodium thiosulfate injection) in Japan for the prevention of cisplatin-induced ototoxicity. The trial met the primary endpoint with a significant reduction in hearing loss in 3-18 year old patients who received PEDMARK.
In pre-market activity on Nasdaq, Fennec shares were gaining around 4% to trade at $8.05, after closing Monday's regular trading 5.6% lower.
The specialty pharmaceutical company said it intends to pursue registration in Japan and will also explore partnering or licensing opportunities for PEDMARK.
Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates, but these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.
STS-J01 is a Phase 2/3, investigator-initiated, open-label, single-arm clinical trial, designed to evaluate PEDMARK for the reduction of cisplatin-induced ototoxicity in pediatric and adolescent and young adult or AYA patients with non-metastatic solid tumors.
The study enrolled 27 patients in the primary cohort with patients aged 3-18 years, and 6 in exploratory cohorts and examined the addition of PEDMARK administered six hours after cisplatin.
The company noted that PEDMARK was well-tolerated in the study. The primary endpoint was the incidence of hearing impairment at the end of treatment in the 3- to 18-year-old cohort, assessed according to American Speech-Language-Hearing Association or ASHA criteria.
Further, the secondary endpoints included safety, antitumor efficacy, pharmacokinetics, and incidence of hearing loss as measured by Brock grading.
The company noted that PEDMARK is the first and only U.S. Food and Drug Administration 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.
The company plans to share full results from the study in a future scientific presentation and submit for publication in a peer-reviewed journal.
Eiso Hiyama, lead investigator and professor in the Department of Pediatric Surgery at Hiroshima University Hospital in Hiroshima, Japan, said, "These encouraging results from the first large-scale pediatric and adolescent and young adults (AYA) trial in Japan demonstrate that PEDMARK can protect hearing without compromising cisplatin's efficacy or introducing any concerning side effects. As a clinician, and with the current unmet medical need of cancer patients in Japan, these findings give me confidence in the effectiveness and safety of PEDMARK which may offer patients the chance for both survival and preserved quality of life."
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