03.12.2014 12:31:46

FDA Sends Notice To CytRx After Placing Cancer Drug Trials On Partial Hold

(RTTNews) - CytRx Corp. (CYTR) Wednesday said the Food and Drug Administration has given written notice for putting its aldoxorubicin clinical trials on partial hold, which bars the the company from enrolling any new patients in the trials until the hold is lifted.

The company announced on November 18 that the FDA has placed a partial hold on clinical trials for the cancer drug aldoxorubicin after a patient died.

CytRx said, in a news release, it will amend study protocols, include appropriate inclusion/exclusion criteria and an additional patient screening assessment, and evaluate serum electrolytes before administering the drug.

Despite the clinical hold, the company said it believes the enrollment rates, as well as the study timelines, will remain materially unchanged.

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