Advaxis Submits INDA To FDA For ADXS-HER2 - Quick Facts

(RTTNews) - Advaxis Inc. (ADXSW, ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, Monday said it submitted an Investigational New Drug application to the United States Food and Drug Administration 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.

The proposed study is designed to evaluate the safety and tolerability of ADXS-HER2 in patients diagnosed with metastatic HER2 expressing solid tumors that 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.