Fennec Phase 3 SIOPEL 6 Study On PEDMARK Meets Primary Goal - Quick Facts

(RTTNews) - Fennec Pharmaceuticals Inc. (FENC, FRX.TO), a specialty pharmaceutical company, announced Monday that its Phase 3 SIOPEL 6 study on PEDMARK (sodium thiosulfate) met primary endpoint.

PEDMARK, a unique formulation of sodium thiosulfate, is for the prevention of platinum-induced ototoxicity in pediatric patients. The company said it plans to pursue regulatory approvals with FDA and EMA.

In pre-market activity, Fennec shares were gaining 3.8 percent to $12.50.

The company noted that the SIOPEL 6 study demonstrated that the addition of STS significantly reduces the incidence of cisplatin-induced hearing loss without any evidence of tumour protection. In the study, the results presented showed that treatment was well tolerated and acute toxicity similar and expected between arms.

The company also reported top-line data for secondary endpoints Event Free Survival and Overall Survival.

Fennec plans to pursue regulatory approval for PEDMARK based on the data from the SIOPEL 6 study along with the proof of principle data from COG ACCL0431. STS has received Orphan Drug Designation in the US in this setting and plans to pursue European Market Exclusivity for Pediatric Use upon approval.

Penelope Brock, International 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."