Fennec Pharma(US:FENC) Globenewswire·2025-12-02 12:01Core Insights - The study demonstrated that PEDMARK significantly reduces hearing loss in pediatric patients aged 3-18 years receiving cisplatin, with rates of 24% and 16% for hearing loss compared to historical rates of 56-63% in cisplatin-only groups [1][2][4] - PEDMARK did not interfere with the antitumor activity of cisplatin, showing a clinical response rate of approximately 95% [1][3] - The company plans to pursue registration for PEDMARK in Japan and is exploring partnership or licensing opportunities based on these positive results [1][5] Study Details - The STS-J01 clinical trial enrolled 33 patients, including 27 in the primary cohort (ages 3-18) and 6 in exploratory cohorts, focusing on the prevention of cisplatin-induced ototoxicity [6][7] - The primary endpoint was the incidence of hearing impairment at the end of treatment, assessed using ASHA criteria, with secondary endpoints including safety and antitumor efficacy [7] Pharmacokinetics and Safety - Pharmacokinetic analyses indicated no reduction in cisplatin exposure, confirming that PEDMARK does not adversely interact with cisplatin [3] - The study reported over 200 treatment-emergent adverse events, none attributed to PEDMARK, indicating it was well-tolerated [4] Clinical Implications - The findings support the effectiveness of PEDMARK in protecting hearing without compromising the efficacy of cisplatin, addressing a significant unmet medical need in Japan [5] - The results reinforce the global clinical evidence for PEDMARK, demonstrating its protective effect across various settings and tumor types [4] Regulatory and Market Potential - Fennec Pharmaceuticals intends to register PEDMARK in Japan and is seeking licensing opportunities, highlighting the potential for market expansion [1][5] - PEDMARK is the first FDA-approved therapy for reducing cisplatin-induced ototoxicity in pediatric patients, with significant implications for patient quality of life [10][12]