Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has completed a pre-IND (Investigational New Drug) meeting with the FDA on August 10 to discuss the development plan for ADXS-PSA, a construct for the treatment of prostate cancer. The FDA addressed the company's questions and provided guidance on the requirements to file an IND to initiate clinical trials. This IND is expected to be filed before the end of the year.
“The FDA has consistently been very helpful. It is critical for Advaxis to understand the regulatory perspective, and the guidance we have received has improved our development program in many ways”
A pre-IND meeting is conducted to develop mutual understanding and agreement between the FDA and the Company regarding the content needed to assess manufacturing, toxicology, pre-clinical and rationale to support a first in humans clinical trial. Based on FDA input, the planned toxicology studies will be completed on schedule for a filing by year end. Once an IND is filed, FDA has 30 days to comment before the Company can begin Phase I trials
"The FDA has consistently been very helpful. It is critical for Advaxis to understand the regulatory perspective, and the guidance we have received has improved our development program in many ways," commented Advaxis Executive Vice President John Rothman. "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."