Aldoxorubicin: Phase III resumed

CytRx resumed enrollment in clinical trials of aldoxorubicin after FDA lifted a partial clinical hold on the product. FDA placed the partial hold after the death of a patient with advanced-stage cancer who did not qualify to participate in any of the ongoing aldoxorubicin clinical trials, but received aldoxorubicin under the company’s compassionate use program (see BioCentury, Dec. 15, 2014). CytRx said it amended a single trial inclusion/exclusion criteria and added serum electrolyte assessment prior to aldoxorubicin treatment. CytRx said trial timelines will remain “materially” unchanged. ...