Fennec Announces Positive Phase 2 Data for PEDMARK® in Japanese Ototoxicity Study

Fennec Pharmaceuticals announced positive results from the investigator-initiated Phase 2 STS-J01 clinical study of its drug, PEDMARK®, in Japan. The study, which evaluated the drug's ability to reduce cisplatin-induced hearing loss (ototoxicity) in pediatric and young adult cancer patients, successfully met its primary endpoint without interfering with cisplatin's antitumor activity.

Key Details

• Primary Endpoint Met: ASHA-defined hearing loss occurred in 24.0% of patients, significantly lower than the prespecified historical benchmark of 56.4% (P=0.001).
• Antitumor Efficacy Maintained: Objective tumor responses were observed in 95.8% of evaluable patients, providing evidence that PEDMARK® did not interfere with cisplatin treatment.
• Strategic Impact: The positive data supports the company's efforts to pursue regulatory registration and explore licensing or partnering opportunities for PEDMARK® in Japan.