Recent Updates — FENC

Fennec Pharmaceuticals announced positive results from the investigator-initiated Phase 2 STS-J01 clinical study of PEDMARK in Japan, which met its primary endpoint by demonstrating significant hearing protection without interfering with cisplatin antitumor activity. Among 25 patients in the primary efficacy population, ASHA-defined hearing loss occurred in 24.0%, significantly lower than the prespecified historical benchmark of 56.4% (P=0.001). Additionally, 84.0% of patients achieved Grade 0 hearing loss by Brock criteria with no Grade 3 or 4 events observed. Objective tumor responses were seen in 95.8% of evaluable patients, supporting the six-hour delayed administration strategy. The company is pursuing registration in Japan and exploring partnering opportunities for its product. Fennec Pharmaceuticals operates as a specialty pharmaceutical company focused on commercializing PEDMARK to reduce cisplatin-induced ototoxicity in pediatric cancer patients.