Update: Partial clinical hold a minor setback
Aldoxorubicin’s randomised clinical trials (RCTs) were placed under a partial clinical hold following the death of a patient with metabolic acidosis who received the drug on a compassionate-use basis and did not qualify for any of the RCTs. CytRx believes this was the only case of metabolic acidosis out of >250 patients who received the drug to date. While already-enrolled patients can continue receiving the drug, no new patients can be dosed until the hold is lifted. CytRx is amending the protocol to exclude acidosis patients from receiving treatment, and believes its existing trial completion forecasts can be maintained if the hold is resolved promptly.
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