Advaxis Completes Pre-IND Meeting with FDA for Immunotherapy
At the meeting, the FDA addressed the Company's questions and provided guidance on the requirements to file an IND to initiate clinical trials.
Advaxis, Inc., a developer of immunotherapies for cancer and infectious diseases, has completed a pre-IND (Investigational New Drug) meeting with the FDA to discuss the development plan for ADXS-HER2, an immunotherapy for the treatment of HER2 expressing cancers.
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 submitted in the first half of 2012.
"In our second pre-IND meeting of the year, the FDA continued to be collegial, receptive, and helpful as we take the necessary steps to expand our oncology pipeline,” said Dr. John Rothman, EVP of
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