Jul 1 2011
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has been granted a pre-Investigational New Drug ("IND") meeting with the U.S. Food and Drug Administration ("FDA") on August 10, 2011 to discuss the CMC, pharmacology, toxicology, and clinical plans for Advaxis PSA, its construct to fight prostate cancer.
The product is being manufactured by Advaxis' contractor, Vibalogics, in Germany. The Company plans to file the IND application later this year to initiate a Phase I/II safety study in humans.