Advaxis has announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on IND applications of its three drugs. Advaxis is a biotechnology company focused on developing cancer immunotherapies.
The company is currently developing three products namely axalimogene filolisbac, ADXS-PSA and ADXS-HER2. In October 2015, Advaxis received a notification from the FDA that its IND applications for axalimogene filolisbac were put on clinical hold in response to the company's submission of a safety report to the FDA.
After discussions with FDA, the company has agreed to implement certain risk mitigation measures like post-administration antibiotic treatment, patient surveillance and monitoring measures.
Now, Advaxis will resume all clinical trials with axalimogene filolisbac, ADXS-PSA and ADXS-HER2. Axalimogene filolisbac is a treatment for HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer and anal cancer.
ADXS-PSA is in clinical development for targeting the prostate-specific antigen (PSA) associated with prostate cancer. Advaxis is developing ADXS-HER2 for the treatment of osteosarcoma in both animals and humans.