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www.fdanews.com/articles/173576-fda-orders-halt-of-axalimogene-clinical-trials

FDA Orders Halt of Axalimogene Clinical Trials

October 13, 2015

The FDA has halted four clinical trials for Advaxis’ investigational cancer drug axalimogene filolisbac following the death of a patient.

Advaxis says the woman died from progression of cervical cancer and that the drug did not contribute to her death.

The four trials affected by the clinical hold were evaluating the drug for three potential indications: head and neck cancer, cervical cancer and anal cancer, COO Greg Mayes said.

Last month, Advaxis released data from stage one of the cervical cancer trial, showing a 38.5 percent survival rate among high-risk patients followed for one year. — Jonathon Shacat