Advaxis Submits Investigational New Drug Application to FDA for ADXS-HER2

Advaxis, Inc.ADXS, a clinical-stage biotechnology company developing cancer immunotherapies, today announced that it submitted an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) to conduct the first-in-human study of ADXS-HER2 (ADXS31-164) for the treatment of HER2 expressing solid tumors. The trial will be initiated in the first quarter of 2015. In May 2014, Advaxis was granted orphan drug designation for ADXS-HER2 in osteosarcoma. Pending FDA's acceptance of the IND submission, the proposed study is designed to evaluate the safety and tolerability of ADXS-HER2 in patients diagnosed with metastatic HER2 expressing solid tumors which include breast, gastric, esophageal, and osteosarcoma. Within 30 calendar days of the IND filing, FDA will notify Advaxis of any questions it has or protocol revisions it requests which may delay initiation of the proposed study. "This clinical trial will provide us with information that allows us to more fully understand the potential of ADXS-HER2 in HER2 expressing cancers, such as breast, gastric, esophageal cancers, and osteosarcoma," stated Daniel J. O'Connor, President and Chief Executive Officer of Advaxis.