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.
‘Advaxis will resume all clinical trials with its cancer products namely axalimogene filolisbac, ADXS-PSA and ADXS-HER2 after USFDA lifts its clinical hold on them.’
After discussions with FDA, the company has agreed to implement certain risk mitigation measures like post-administration antibiotic treatment, patient surveillance and monitoring measures.
"We appreciate the FDA's review of this matter. We are grateful that our clinical trials will now resume so that we may continue investigating new treatments for unmet medical needs. We thank both the patients and their physicians for their participation in our clinical trials," said Daniel J. O'Connor, President and Chief Executive Officer of Advaxis.
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.