Fennec announces Phase 2/3 STS-J01 trial met primary endpoint

Fennec (FENC) Pharmaceuticals announced positive topline results from the investigator-initiated Phase 2/3 STS-J01 clinical trial evaluating PEDMARK for the reduction of cisplatin-induced ototoxicity in pediatric and adolescent and young adult, AYA, patients with non-metastatic solid tumors in Japan. The study, which enrolled 27 patients in the primary cohort 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 PEDMARK experienced hearing loss as assessed by the American Speech-Language-Hearing Association criteria and Brock grade scaling, respectively. These rates compare favorably to the cisplatin-only arms of PEDMARK’s pivotal Phase 3 trials, where 56% of children developed clinically significant hearing loss using ASHA criteria and 63% developed hearing impairment defined as Brock Grade greater than or equal to1. Further, the study demonstrated that among the largest subgroup of patients aged 7-18 years, hearing loss occurred in only 19% and 14.3%.