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news.Fennec Pharmaceuticals reported the second sodium thiosulfate Phase III study, conducted by the International Childhood Liver Tumour Strategy Group, SIOPEL 6, has fully enrolled and is now closed for recruitment.
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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."