Fennec Pharmaceuticals Inc Announces Launch of European Named Patient Programme for Sodium Thiosulfate for Pediatric Patients with Standard Risk Hepatoblastoma
May 30, 2017 at 12:36 pm
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Fennec Pharmaceuticals Inc. announced the launch of a Named Patient Programme (NPP) in Europe for STS. Fennec's NPP is intended to make STS available to patients before commercial availability in certain countries. Where mechanisms exist and in accordance with local regulations, Fennec will make STS available for pediatric patients with Standard Risk Hepatoblastoma. While Platinum based chemotherapy remains the most frequently prescribed treatment for many childhood cancers it causes hearing loss in a significant proportion of cases, with younger patients more at risk where the incidence can be over 70%. The social and economic consequences of hearing loss in children can be devastating. There is no preventative treatment and many survivors of childhood cancer require expensive and technically difficult cochlear (inner ear) implants or hearing aids that often provide suboptimal benefit. Additionally the costs of educational and lifetime support from social services may place an additional burden on society that could be reduced with an effective preventative therapy. STS has been studied by cooperative groups in two Phase 3 clinical studies of reduction of ototoxicity, the COG ACCL0431 and SIOPEL 6. Both studies are closed to recruitment. COG ACCL0431 final results were published in The Lancet Oncology in December 2016. SIOPEL 6 initial results will be available in the fourth quarter of 2017. Pending favorable SIOPEL 6 results, Fennec intends to file NDA/MAA submissions for STS.
Fennec Pharmaceuticals Inc. is a commercial-stage biopharmaceutical company focused on its product candidate PEDMARK. It sells its product through a field force, including Regional Pediatric Oncology Specialists and medical science liaisons who are helping to educate the medical communities and patients about cisplatin induced ototoxicity and its programs supporting patient access to PEDMARK. PEDMARK is a Food and Drug Administration approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. It is a formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is a therapeutic agent with a dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6. It has established Fennec HEARS, a single source program designed to connect PEDMARK patients.
Fennec Pharmaceuticals Inc Announces Launch of European Named Patient Programme for Sodium Thiosulfate for Pediatric Patients with Standard Risk Hepatoblastoma