116 total patients enrolled
Independent safety data review of first 100 patients expected Q1 2015
Research Triangle Park, NC, January 5, 2015 – Fennec Pharmaceuticals Inc. (TSX: FRX, OTCQB: FENCF), today reported the second sodium thiosulfate Phase 3 study, conducted by the International Childhood Liver Tumour Strategy Group, SIOPEL 6, has fully enrolled and is now closed for recruitment. One hundred and sixteen patients in 46 clinical centers from 12 countries participated in the study.
Final protocol pre-specified Independent Data Monitoring Committee (IDMC) review on the first 100 patients, assessing any potential concern of an adverse effect of STS on the efficacy of the cisplatin chemotherapy, is expected in the first quarter of 2015. For the primary hearing endpoint analysis, protocol pre-specified interim hearing assessment of 34, 68 and 102 evaluable patients will be performed once these patients have reached 3.5 years of age.
“We are delighted to announce that SIOPEL 6, comparing hearing outcome in young children with primary liver cancer receiving cisplatin chemotherapy with or without the otoprotectant, sodium thiosulfate, has reached recruitment,” stated Penelope Brock, MD, SIOPEL 6 Principal Investigator. “We will now await the hearing outcome, which will only be assessed once all the children have reached an age when a gold standard behavioural hearing test can be carried out.”
“The first patient was treated in SIOPEL 6 in December 2007, since then the entire international SIOPEL team have done an outstanding job of cooperating to fully enroll this study in an ultra rare disease,” said Rosty Raykov, CEO of Fennec Pharmaceuticals, “We wish to thank Drs. Brock, Bruce Morland, SIOPEL Chairman, Margaret Childs, SIOPEL 6 clinical manager, all participating investigators, support teams and families for their commitment to sodium thiosulfate.”
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.
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Fennec Pharmaceuticals, Inc.
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