Research Triangle Park, NC, December 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.
Forward looking statements
Except for historical information described in this press release, all other statements are forward-looking. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks that regulatory and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital requirements in different countries and municipalities, the proposed sale to Elion may not be completed and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2015. Fennec Pharmaceuticals, Inc. disclaims any obligation to update these forward-looking statements except as required by law.
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Chief Executive Officer
Fennec Pharmaceuticals Inc.
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