FDA places clinical hold on Advaxis' axalimogene filolisbac

Advaxis Inc. (NASDAQ:ADXS) fell $2.66 (26%) to $7.65 in after-hours trading Tuesday after it said FDA placed a clinical hold on an IND for axalimogene filolisbac ( ADXS-HPV) to treat cervical cancer. The company said the hold would affect four clinical trials of the live Listeria monocytogenes-based immunotherapy expressing E7 transforming protein ( Human papillomavirus-16; HpV16gp2).

Advaxis said FDA placed the hold in response to a safety report concerning the death of a patient who tested positive for the Listeria strain used in axalimogene filolisbac more than two years after her last treatment with the therapy. The patient received antibiotics during hospitalization and was discharged, but died after experiencing respiratory distress about two weeks later. Advaxis said its Listeria strain is incapable of causing infection and said the investigator ruled that the patient died due to progression of her cervical cancer. ...