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January 21, 2014
06:33 EDTCYTRCytRx receives FDA approval to continue aldoxorubicin clinical trial
CytRx announced it has received approval from the FDA to continue dosing patients with aldoxorubicin until disease progression in a planned pivotal, global Phase 3 clinical trial with aldoxorubicin as a second-line treatment for soft tissue sarcomas. The clinical trial is scheduled to begin this quarter. For purposes of the clinical trial, disease progression is defined as an increase in the size of measurable tumors by 20% or the development of a new tumor lesion.
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September 30, 2014
06:10 EDTCYTRCytRx initiates global Phase 2 clinical trial of aldoxorubicin
CytRx announced the initiation of a global Phase 2b clinical trial evaluating aldoxorubicin compared to topotecan in subjects with extensive-stage small cell lung cancer, or SCLC, who have relapsed or were refractory to prior chemotherapy. Aldoxorubicin is CytRx's modified version of the widely-used chemotherapeutic agent, doxorubicin. CytRx has received Orphan Drug Designation for the treatment of SCLC from the FDA. Enrollment is expected to be completed in 2015 and PFS data are anticipated by mid-2016. The study is expected to involve approximately 40 clinical trial sites in the U.S., Spain, Italy and Hungary.
September 29, 2014
06:18 EDTCYTRCytRx receives multiple FDA orphan drug designations for aldoxorubicin
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September 26, 2014
11:04 EDTCYTRCytRx drug granted orphan designation in treatment of various cancers
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10:03 EDTCYTRCytRx treatment of glioblastoma multiforme granted FDA orphan status
The FDA designated aldoxorubicin from CytRx for orphan drug status as a treatment of glioblastoma multiforme, according to a post to the agency's site. Reference Link

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