- Positive recommendation after final safety review of 100 Patients
Research Triangle Park, NC, February 2, 2015 – Fennec Pharmaceuticals Inc. (TSX: FRX, OTCQB: FENCF), a company focused on the development of sodium thiosulfate (STS) for the prevention of ototoxicity from cisplatin in pediatric patients, announced that the IDMC overseeing the SIOPEL 6 phase 3 clinical trial recommended that the study be continued as planned. The IDMC has been established to assess any potential concern of an adverse effect of STS on the efficacy of the cisplatin chemotherapy and to review safety according to protocol pre-specified patient numbers. Previously, the IDMC reached similar conclusion after reviewing the safety of 20, 40, 60 and 80 patients and their current recommendation on 100 patients to continue the clinical trial represents the last and final safety review.
“We are pleased that based on their final safety review the IDMC has recommended continuation of the SIOPEL 6 Phase 3 clinical trial”, commented Mr. Rosty Raykov, Fennec’s President and CEO, “patient recruitment has now been completed and we look forward to the efficacy outcome based on audiometric results which will be evaluated on an on-going basis as each child reaches the age of 3.5 years. The results of both safety and efficacy will be presented at important international scientific conferences.”
About Siopel 6
SIOPEL 6 is 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. From the beginning of 2007 to the end 2014, 45 sites from 12 countries enrolled 113 evaluable patients. The study is closed to recruitment and all protocol pre-specified IDMC safety reviews are now complete. The primary efficacy hearing endpoint analysis can be performed once patients have reached 3.5 years of age and an audiometry test can be carried out.
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.
Sodium thiosulfate (STS) is a water-soluble thiol compound that acts as a chemical reducing agent. Delayed administration (4–8 h) of high dose STS (16–20 g/m²) protects against platinum-induced ototoxicity in animal models and in patients.
In the U.S., it is estimated that over 2,000 children receive platinum based chemotherapy for localized cancers and globally approximately 7,000. Of these, 40% to 90% develop profound and irreversible ototoxicity. The incidence of hearing loss in these children depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently no established preventive agent for this hearing loss and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. Infants and young children at critical stages of development lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.
STS has the potential to prevent chemotherapy-induced hearing loss and may be the first available agent approved for this condition.
STS has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.
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, 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, 2013. Fennec Pharmaceuticals, Inc. disclaims any obligation to update these forward-looking statements except as required by law.
For further information, please contact:
Chief Executive Officer
Fennec Pharmaceuticals, Inc.
T: (919) 636-5144