FDA guides Advaxis over ADXS-PSA clinical trials

In the pre-IND meeting, Advaxis has discussed its development plan for ADXS-PSA with the FDA.

Based on FDA input, the planned toxicology studies will be completed on schedule for a filing by year end.

Advaxis executive vice president John Rothman said it is critical for the company to understand the regulatory perspective, and the guidance they have received has improved their development program in many ways.

"Because each new construct is based on live attenuated Listeria monocytogenes, every successful interaction with the FDA strengthens the regulatory framework for this entire new class of immunotherapies," Rothman said.