News

(RTTNews) - Fennec Pharmaceuticals Inc. (FENC) announced that detailed results from the investigator-initiated Phase 2 STS-J01 clinical study evaluating Pedmark in Japanese pediatric patients will be presented orally at the SIOP 2026 Annual Congress in Washington, D.C., on October 17, 2026.

Pedmark is an FDA-approved formulation of sodium thiosulfate designed to reduce the risk of cisplatin-induced ototoxicity—a form of permanent hearing loss that can occur in children receiving cisplatin chemotherapy. Hearing loss from cisplatin can significantly affect speech, learning, and long-term development, marking prevention an important clinical priority.

Phase 2 STS-J01 Study

The STS-J01 trial evaluated Pedmark in Japanese pediatric patients receiving cisplatin-based chemotherapy. The study assessed Pedmark's ability to reduce ototoxicity while maintaining anticancer treatment effectiveness. According to the Fennec, the oral presentation will include detailed efficacy and safety findings from the trial, expanding on previously shared topline results.

Clinical Significance

Cisplatin remains a widely used chemotherapy agent in pediatric oncology, but its risk of causing irreversible hearing loss has driven interest in irreversible hearing loss has driven interest in protective therapies. Pedmark is the first FDA-approved treatment specifically indicated to reduce this risk in children. The STS-J01 data are expected to provide additional insights into Pedmark's performance in a Japanese pediatric population, supporting global clinical understanding of the therapy.

Company Commentary

Fennec stated that the upcoming presentation underscores the company's commitment to advancing evidence-based approaches to preventing chemotherapy-related hearing loss in children. The company noted that the STS-J01 results may help inform future clinical and regulatory discussions in Japan.

FENC has traded between $5.65 and $13.25 over past year. The stock is currently trading at $10.84, up 2.75%.