Fennec Pharmaceuticals revealed the data from its Phase 3 SIOPEL 6 study during the late breaker session on Saturday, October 14, 2017 at SIOP 2017 in Washington, DC.
Fennec said that the SIOPEL 6 study met its primary endpoint, as the addition of STS significantly reduces the incidence of cisplatin-induced hearing loss without any evidence of tumour protection. The company said it will go for regulatory approval for PEDMARK based on the data from the SIOPEL 6 study along with the proof of principle data from COG ACCL0431. By the way, STS has received Orphan Drug Designation in the US in this setting and plans to pursue European Market Exclusivity for Pediatric Use upon approval, the company pointed out.
Penelope Brock, Chair of SIOPEL said: “I am absolutely delighted that after 30 years of research we have found a safe way to reduce ototoxicity in children receiving platinum containing chemotherapy. This means that children who are cured from cancer after receiving platinum treatment can look forward to a normal healthy life, fully integrated into society. I believe this marks a new standard of care in pediatric oncology.”
The company also reported top-line data for secondary endpoints Event Free Survival (EFS) and Overall Survival (OS). The combination of Cis+STS was generally well tolerated.
Rosty Raykov, CEO of Fennec, said that PEDMARK would be an important therapy for patients and caregivers where currently there are no treatment options.