Advaxis Brand Drug On Clinical Hold
The clinical-stage biotechnology company Advaxis, which as stated on the company’s website focuses on developing cancer immunotherapies that use the body’s natural immune system to redirect the immune response to kill cancer, has come under federal scrutiny following the death of a clinical trial patient..
FDA Clinical Hold Details
After Advaxis sent a safety report to the FDA that mentioned a patient’s death, clinical mid-stage trials of the experimental axalimogene filolisbac drug were put on hold.
According to Reuters, the patient was admitted to the hospital and was undergoing treatment for an aggressive stage cervical cancer. Advaxis claims, however, that the patient died as a result of the ongoing disease and that the drug axalimogene filolisbac played no part.
According to Advaxis, the FDA has requested to be shown more proof that the experimental drug did not cause the patient’s death.
HPV and Cervical Cancer Details
The following information was provided by cancer.gov:
- HPV or Human Papilloma Virus is a group of more than 200 related viruses that can lead to types of cancer, one being cervical cancer.
- Cervical cancer occurs when abnormal cells on the cervix grow rapidly.
- HPV is sexually transmitted through skin and mucous membranes.
- HPV types 16 and 18 cause just about every case of cervical cancer.