Fennec Pharma: Pedmark SIOPEL 6 Study Meets Primary Endpoint - Quick Facts

(RTTNews) - Fennec Pharmaceuticals Inc. (FENC, FRX.TO), a specialty pharmaceutical company focused on the development of PEDMARKTM (a formulation of sodium thiosulfate, or STS, presented the final results from the SIOPEL 6 study, a multi-centre open label randomized phase 3 study evaluating the efficacy of STS in reducing ototoxicity in patients receiving cisplatin monotherapy for standard risk hepatoblastoma. The company said the SIOPEL 6 study met its primary endpoint. Sodium thiosulfate, administered 6 hours after cisplatin chemotherapy, reduced the incidence of cisplatin-induced hearing loss in children with standard-risk hepatoblastoma without jeopardizing overall or event-free survival. In the study, the results presented showed that treatment was well tolerated and acute toxicity similar and expected between arms.

In March 2018, Fennec Pharma was granted Fast Track designation and Breakthrough Therapy designation for PEDMARKTM. Fennec plans to pursue regulatory approval for PEDMARKTM based on the data from the SIOPEL 6 study along with the data from Children Oncology Group ACCL0431 study. Fennec anticipates commencing regulatory submissions in the fourth quarter of 2018.