FDA Issues Formal Clinical Hold on Aldoxorubicin Trials

December 3, 2014
Randi Hernandez

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

CytRx receives formal written communication from FDA on a prior decision for a partial clinical hold for CytRx's trials involving chemotherapeutic agent aldoxorubicin.

FDA issued written communication on Dec. 3, 2014 to inform CytRx, a biopharmaceutical company developing aldoxorubicin for Karposi’s sarcoma and glioblastoma multiforme, of a partial clinical hold on its trials. The written communication is consistent with prior verbal communication from FDA. The clinical trials were placed on a partial hold following the death of a patient.

CytRx press release.

Aldoxorubicin combines doxorubicin, a strong chemotherapeutic, with a novel single-molecule linker that binds directly to circulating albumin. Doxorubicin is then released in the acidic environment of the tumor, where concentration of albumin is highest. This method allows for greater doses (3.5 to 4 times the typical amount) of doxorubicin to be administered directly to the tumor site without the toxic side effects usually associated with such a high dose.

CytRx said it believes the hold will not affect its timelines and its ongoing trials will remain “materially unchanged.”

Sources: CytRx