20.01.2015 12:52:18
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CytRx : FDA Removes Partial Clinical Hold For Aldoxorubicin Trials
(RTTNews) - CytRx Corp. (CYTR) announced that the United States Food and Drug Administration or FDA has removed the partial clinical hold on the Company's aldoxorubicin clinical trials. Enrollment and dosing of new patients is now permitted after study sites' Institutional Review Boards (IRBs) approve the revised trial protocols.
CytRx currently believes that enrollment rates and timelines for its trials will remain materially unchanged.
The company expects to complete enrollment in its ongoing pivotal global Phase 3 trial in second-line soft tissue sarcoma by the end of 2015 and unblind the clinical data by mid-2016. Subject to FDA approval, CytRx's market launch of aldoxorubicin for second line soft tissue sarcoma is projected to commence in 2017.
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