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news.US-based biopharmaceutical research and development firm CytRx has received notice from the US Food and Drug Administration (FDA) that its clinical trials for aldoxorubicin have been placed on partial clinical hold.
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According to FDA, all currently enrolled patients can continue receiving aldoxorubicin treatment, or comparator drugs, as per study protocols.
Additionally, the company cannot enrol new patients until the partial clinical hold is lifted.
The hold is due to the reported death of a patient with advanced-stage cancer who did not qualify to participate in any of the ongoing aldoxorubicin clinical trials, but had received aldoxorubicin under the company’s expanded access program.
As per FDA’s request, the company will amend all aldoxorubicin trial study protocols to include a suitable inclusion or exclusion criteria, an additional patient screening assessment and an evaluation of serum electrolytes prior to administration of aldoxorubicin.
Currently, the company is working diligently in collaboration with the FDA to seek the release of the clinical hold and resume enrollment in its clinical trials as expeditiously as possible.
The company plans to report preliminary results from the ongoing Phase II clinical trial of aldoxorubicin in Kaposi’s Sarcoma in the second quarter of 2015 and preliminary results from the ongoing Phase II clinical trial of aldoxorubicin in glioblastoma multiforme in the first half of 2015.
By the end of 2015, the company remains committed to completing enrollment of its ongoing pivotal global Phase III trial in second-line soft tissue sarcoma.