Axalimogene filolisbac regulatory update

FDA placed a clinical hold on an IND for axalimogene filolisbac from Advaxis. The company said the hold would affect 4 clinical trials of the live Listeria monocytogenes-based immunotherapy expressing E7 transforming protein ( Human papillomavirus-16; HpV16gp2). The product is in Phase II testing in invasive cervical cancer and Phase I/II testing in head and neck cancer and anal cancer.

Advaxis said FDA placed the hold in response to a safety report concerning the death of a patient who tested positive for L. monocytogenes more than 2 years after her last treatment in an investigator-led trial of the therapy. The patient received antibiotics during hospitalization and was discharged, but died after experiencing respiratory distress about 2 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. ...