FDA halts Advaxis immuno-oncology trials after patient death
- A woman with cervical cancer died during a clincal trial involving Advaxis' axalimogene. The FDA is concerned that drug may have been involved, but Advaxis asserts that the patient died of cervical cancer.
- The main concern is that the patient's death was caused by the bacteria, listeria, used to deliver the immunotherapy.
- Shares of Advaxis were down 25% on the news that the trials had been halted. They rebounded later, but have fallen again on Thursday.
Axamilogene is made using the listeria bacteria, which acts as a way to hit different cancer targets. In this case, a woman who was treated in early 2013, was hospitalized with a bacterial infection in July 2015. It turned out that the infection was caused by an Advaxis-engineered listeria bacteria. The FDA is investigating the death, and all four trials associated with axamilogene have been halted until further notice.
One thing that has raised eyebrows is the fact athat although Advaxis was informed of hte decision about the clinical hold last Thursday, investors weren't told until a conference call on Tuesday. Advaxis is calling this an isolated incident and is looking forward to resuming reserach as soon as possible.