Advaxis, a clinical-stage biotechnology company that develops cancer immunotherapies, on Wednesday said that the U.S. Food and Drug Administration (FDA) lifted the clinical hold on experimental cancer therapies.
This announcement made investors very excited, and the company’s shares rose by 38% today.
In October, the agency put on axalimogene filolisbac after a death of patient. The hold also included as ADXS-PSA and ADXS-HER2. The company clarified that the drug was not responsible for the death, which occurred due to progression of cervical cancer.
Axalimogene filolisbac is the company’s lead therapy for the treatment of HPV-associated cancers. The drug is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer.
ADXS-PSA is an immunotherapy for the prostate-specific antigen (PSA) associated with prostate cancer, while ADXS-HER2 is being developed to target HER2 expressing cancers.
Following discussions with the FDA, Advaxis agreed to implement certain risk mitigation measures, including revised study protocol inclusion / exclusion criteria, post-administration antibiotic treatment and patient surveillance and monitoring measures.
Advaxis said that it will resume all clinical trials with axalimogene filolisbac, ADXS-PSA and ADXS-HER2.
“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,” Advaxis President and Chief Executive Officer Daniel J. O’Connor said in a statement.