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November 9, 2012
08:34 EDTCYTRCytRx says had positive meeting with FDA to discuss potential Phase 3 trial
The company announced that it has held a positive meeting with the FDA to discuss a potential Phase 3 pivotal trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. “We are planning to submit a special protocol assessment for the Phase 3 trial in patients with advanced soft tissue sarcomas,” said President and CEO Steven A. Kriegsman. “An agreement with the FDA with regards to an SPA would provide a clear regulatory pathway through the approval process. The initiation of a Phase 3 program for our lead drug candidate aldoxorubicin would represent a significant milestone in CytRx’s efforts to bring value to our stockholders and for those patients suffering from soft tissue sarcoma.”
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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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