RESEARCH TRIANGLE PARK, NORTH CAROLINA--(Marketwired - Dec. 1, 2016) - Fennec Pharmaceuticals Inc. (TSX:FRX) (OTCQB:FENCF), a specialty pharmaceutical company focused on the development of Sodium Thiosulfate (STS) for the prevention of platinum-induced ototoxicity in pediatric patients, today announced The Lancet Oncology published the results from the Children's Oncology Group, "Effects of Sodium Thiosulfate versus Observation on Development of Cisplatin-Induced Hearing Loss and Survival in Children with Cancer: Results from the Children's Oncology Group ACCL0431 Randomised Cohort Trial".
"Through the successful completion of ACCL0431, identification of sodium thiosulfate as an effective otoprotectant is an important development in supportive care research for children with cancer," said David R. Freyer, DO, MS: Study Chair, ACCL0431, and Director of the Survivorship & Supportive Care Program, Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles. "Through supporting and stimulating additional studies in this area, these results will contribute substantially to the ultimate goal of preventing cisplatin-induced hearing loss and its devastating consequences."
"I would like to thank Dr. David Freyer and contributing authors as well as all participating investigators and patients in COG ACCL0431 for their dedication and support of STS as a potential treatment in cisplatin-induced hearing loss," said Rosty Raykov, Chief Executive Officer of Fennec. "We look forward to the results of SIOPEL 6 anticipated in 2017 for further enlightenment of the potential future role for STS."
Link to The Lancet Oncology: http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30625-8/fulltext
About Sodium Thiosulfate (STS)
Cisplatin and other platinum compounds are essential chemotherapeutic components for many pediatric malignancies. Unfortunately, platinum-based therapies cause ototoxicity in many patients and are particularly harmful to the survivors of pediatric cancer.
In the U.S., Europe and Japan it is estimated that up to 10,000 children are diagnosed with local cancers that may receive platinum based chemotherapy. Localized cancers that receive platinum agents may have overall survival rates of greater than 80% further emphasizing the need for quality of life treatments. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy and many of them require hearing aids for life. There is currently no established preventive agent for cisplatin-induced hearing loss and expensive and technically difficult cochlear (inner ear) implants provide suboptimal benefit. As a result, infants and young children at critical stages of development lack speech language development and literacy, while older children and adolescents lack social-emotional development and educational achievement.
STS has been studied by cooperative groups in two Phase 3 clinical studies of reduction of ototoxicity, the COG Protocol ACCL0431 and SIOPEL 6. Both studies are closed to recruitment. COG ACCL0431 final results were published in the Lancet Oncology. SIOPEL 6 initial results will be available in the fourth quarter of 2017.
About Fennec Pharmaceuticals
Fennec Pharmaceuticals, Inc., is a specialty pharmaceutical company focused on the development of Sodium Thiosulfate (STS) for the prevention of platinum-induced ototoxicity in pediatric patients. STS has received Orphan Drug Designation in the US in this setting. For more information, please visit www.fennecpharma.com.
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