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Adherex Technologies Inc Reports Feedback From FDA From End Of Phase 2 Meeting

Thursday, 23 May 2013 09:07pm EDT 

Adherex Technologies Inc announced that it has received feedback from the FDA at an End-of-Phase 2 meeting held yesterday. During the FDA meeting, Adherex reviewed the opportunity that eniluracil offers to Metastatic Breast Cancer (MBC) patients who had rapid disease progression on capecitabine. Adherex proposed a small pivotal single arm clinical study addressing the special ability of eniluracil/5-FU/leucovorin to meet the medical needs of these patients. However, the agency strongly recommended that Adherex consider other larger clinical trial design alternatives for the future development of eniluracil in MBC. In light of the Company's limited resources, Adherex is taking the Agency's recommendations into consideration as it reviews the feasibility of these and other clinical options. The Children Oncology Group Phase 3 trial evaluating Sodium Thiosulfate (STS) as an otoprotectant after cisplatin exposure, completed enrollment of 135 children in 2012. Results from the Phase 3 trial conducted by Children Oncology Group are expected during the second or third quarter of 2013. 

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