other material
confidence high
sentiment positive
materiality 0.60
Fennec announces new PEDMARK data at ASCO showing hearing loss reduction in pediatric/AYA patients
FENNEC PHARMACEUTICALS INC.
- Phase 2/3 STS-J01 study met primary endpoint: hearing loss 16-24% vs 56-63% historical control.
- Randomized Phase 1 trial of cisplatin +/- PEDMARK for metastatic germ cell tumor opened at City of Hope.
- Retrospective case series (9 AYA patients) shows PEDMARK feasible and does not compromise cisplatin antitumor activity.
- Real-world data in 15 head & neck cancer adults: PEDMARK safe ≥6h after cisplatin, hearing preserved.
- Company expands evidence base for PEDMARK in broader populations beyond current pediatric approval.