PharmExec Blog CytRx Faces Partial Clinical Hold after Death in Compassionate Use Program

CytRx announced on Tuesday that FDA gave notice of a partial clinical hold for trials for its oncology candidate aldoxorubicin.

The hold results from a reported death of a late-stage cancer patient “who did not qualify to participate in any of the ongoing aldoxorubicin clinical trials, but had received aldoxorubicin under the Company’s expanded access (“compassionate use”) program”, states the release.

The tragedy may become a talking point in the debate surrounding risk companies take on by allowing access to drugs in expanded access programs.

The news serves as an update to an October PharmExec blogpost, from a panel discussion at the Rare Diseases and Orphan Products Breakthrough Summit held by the National Organization for Rare Disease (NORD).

In the post entitled Expanded Access: Myths, Truth and Behavior, PharmExec quoted Kay Holcombe, Senior Vice President, Science Policy at Biotechnology Industry Organization (BIO) who said, “Not all companies are big, small companies are scared, and myths drive behavior.”

The debate at NORD’s summit highlighted Chimerix’s very public exchange surrounding Josh Hardy, an 8-year-old boy and pressure to allow expanded access to anti-viral drug, brincidofovir (CMX001).

Two FDA officials said that they had put to rest the myth that AEs in expanded access had affected the approvability of any product they had seen in their time at FDA.

Thanks to a tipster who commented on CytRx’s announcement.