Research Triangle Park, NC, May 30, 2017 – 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 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.
“In clinical trials, Sodium Thiosulfate has been shown to reduce hearing loss in children receiving cisplatin chemotherapy. It has also been shown not to protect the tumour from cisplatin efficacy in standard risk hepatoblastoma. Cisplatin is the most important drug in treating children with hepatoblastoma,” stated Penelope “Peppy” R. Brock, MD, PhD, MA, International Chair, SIOPEL 6. “I am therefore absolutely delighted that the hearing protection offered by Sodium Thiosulfate is going to be made available through a Named Patient Programme which is opening for children with Standard Risk Hepatoblastoma.”
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 7,000 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 and hearing aids 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.
Named Patient Programme Contact
European based Healthcare Professionals can obtain details about STS Named Patient Programme by emailing clinical@fennecpharma.com.
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, 2016. Fennec Pharmaceuticals, Inc. disclaims any obligation to update these forward-looking statements except as required by law.
For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.
For further information, please contact:
Rosty Raykov
Chief Executive Officer
Fennec Pharmaceuticals Inc.
T: (919) 636-5144