18.11.2014 16:58:16
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CytRx's Cancer Drug Trial On FDA Partial Hold After Patient Death
(RTTNews) - Cancer drug maker CytRx Corp. (CYTR), Tuesday said the FDA has placed a partial hold on clinical trials of its investigational cancer drug aldoxorubicin, following the death of a patient. Shares of CytRx tanked eight percent on the news.
The Los Angeles, California-based company said the patient who died had advanced-stage cancer and was not qualified to participate in any of the ongoing aldoxorubicin clinical trials, but received the treatment under its expanded access program.
Now, no new patients can be enrolled for the clinical trials until the hold is lifted. However, patients currently enlisted will continue to receive aldoxorubicin treatment.
CytRx said it will amend all aldoxorubicin study protocols to include an appropriate inclusion/exclusion criteria, an additional patient screening assessment and an evaluation of serum electrolytes prior to aldoxorubicin administration.
Aldoxorubicin combines chemotherapeutic agent doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream.
The company assured that the timelines of its ongoing trials remains unchanged.
CYTR is currently trading at $2.54, down $0.22 or 7.97%, on the Nasdaq.
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