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BRIEF-Cytrx announces update on regulatory pathway for aldoxorubicin in soft tissue sarcomas
June 8, 2017 / 1:26 PM / 4 months ago

BRIEF-Cytrx announces update on regulatory pathway for aldoxorubicin in soft tissue sarcomas

June 8 (Reuters) - Cytrx Corp:

* Cytrx announces update on the regulatory pathway for aldoxorubicin in soft tissue sarcomas

* Cytrx Corp says plans to submit a rolling nda under section 505(b)(2) to fda for aldoxorubicin as a treatment for sts

* Cytrx Corp says nda submission is not reliant solely on recently completed phase 3 clinical trial in sts or overall survival results

* Cytrx -pharmacokinetic clinical trial, phase 2b and phase 3 trials in sts, preclinical studies, will serve as “scientific bridges” for aldoxorubicin , doxorubicin

* Cytrx -studies, along with published literature of doxorubicin’s effectiveness and safety, will form basis of nda filing for aldoxorubicin

* Cytrx corp -additionally, cytrx’s previously approved special protocol assessment is no longer applicable Source text for Eikon: Further company coverage:

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