CytRx gets OK to extend drug-dosing cycles in Phase III cancer study


CytRx (CYTR +9.4%) jumps after the FDA approves the lengthening of the dosing cycles of the firm's Aldoxorubicin treatment for soft-tissue sarcomas in a Phase III trial.

Patients will now receive Aldoxorubicin until disease progression, defined as "an increase in the size of measurable tumors by 20% or the development of a new tumor lesion." Originally, subjects were only to receive the treatment for six cycles.

The study is due to begin this quarter.

"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...(than) in CytRx's recent highly successful global Phase 2b trial for advanced soft tissue sarcomas," says Sant Chawla, the principal investigator of the Phase 3 testing. (PR)

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Comments (1)
  • Grant Payne
    , contributor
    Comments (337) | Send Message
     
    This could imply that the FDA is pleased with what they're seeing in Aldox performance, certainly they like it enough to allow it to operate in the trials like Dox does in the patient care setting, until >20% tumor growth or unacceptable toxicity.
    Should over all survival data (coming 3Q 2014) prove superior to Dox from the last soft tissue sarcoma trial, then this stock will go through the roof.
    It's already superior to Dox in terms of PFS and toxicity alone, which to me would be enough to warrant an FDA approval.
    Should OS, PFS, and toxicity be better, I see no reason why Aldox can't replace Dox all over the globe.
    23 Jan 2014, 04:46 PM Reply Like
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