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CytRx Receives FDA Approval To Extend Aldoxorubicin Dosing Cycles Until Disease Progression In Upcoming Pivotal, Global Phase 3 Trial For Soft Tissue Sarcomas

Stocks in this article: CYTR

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company specializing in oncology, today announced it has received approval from the U.S. Food and Drug Administration (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. The following table sets forth the cumulative dose of doxorubicin in prior and planned CytRx clinical trials:

     
       

Cumulative Doxorubicin Dose

Recognized maximum dose associated with cardiac toxicity - Doxorubicin

      450 mg/m 2

CytRx Phase 2b Clinical Trial – Aldoxorubicin

      1,560 mg/m 2

CytRx Phase 1b/2 Clinical Trial– Aldoxorubicin

      2,080 mg/m 2

CytRx Pharmacokinetics Clinical Trial – Aldoxorubicin

      1600-3200 mg/m 2

CytRx Pivotal Phase 3 Clinical Trial– Aldoxorubicin

      Up to Disease Progression
 

The study design under the trial’s Special Protocol Assessment (SPA) originally called for dosing to be stopped after six treatment cycles. FDA acceptance of a protocol amendment to include a dose-to-progression regimen demonstrates the superior cardiac safety thus far of administrating a cumulative 2,080 mg/m 2 dose of aldoxorubicin as seen in the Company’s recently announced global, Phase 2b clinical trial results (which is equivalent to 1,560 mg/m 2 of doxorubicin), which is 3.5 times the recognized maximum cumulative dose of doxorubicin (450 mg/m 2) associated with cardiac toxicity (heart damage).

Sant Chawla, M.D., of the Sarcoma Oncology Center in Santa Monica, Calif., and principal investigator of the Phase 3 pivotal trial, commented, “In addition to observing no significant cardiotoxicity of aldoxorubicin to this point, the FDA’s agreement to extend dosing beyond six cycles offers the potential to achieve even greater progression-free survival efficacy results than were demonstrated in CytRx’s recent highly successful global Phase 2b trial for advanced soft tissue sarcomas. As the principal investigator for this trial, I can say that we are very pleased to have the opportunity to provide the maximum benefits of aldoxorubicin to the patients around the world.”

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