Fennec Pharmaceuticals Announces Oral Presentation of Detailed Results from Investigator-Initiated Phase 2 STS-J01 Clinical Study of Pedmark® in Japan at SIOP 2026
Fennec Pharmaceuticals presented detailed results from the investigator-initiated Phase 2 STS-J01 study of PEDMARK in Japan at the SIOP 2026 annual meeting, with ASHA-defined hearing loss in 24.0% of patients versus a prespecified historical benchmark of 56.4% (P=0.001). By Brock criteria, 84.0% of patients had Grade 0 hearing loss and no Grade 3 or 4 hearing loss was observed, while objective tumor responses appeared in 23 of 24 evaluable patients (95.8%) — making STS-J01 the third study to show PEDMARK does not interfere with cisplatin antitumor activity, with pharmacokinetic data supporting the six-hour dosing interval.
Key figures
- Drug Name
- PEDMARK (sodium thiosulfate injection)
- Phase Of Trial
- Phase 2
- P value
- 0.001
- Study sites
- 11
- Grade0 brock rate
- 84.0%
- Patients enrolled
- 33
- Historical benchmark
- 56.4%
- Asha hearing loss rate
- 24.0%
- Objective response rate
- 95.8%
- Free of asha hearing loss
- 76.0%
- Primary efficacy population
- 25
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