The US Food and Drug Administration has already lifted its clinical hold on three of the drug therapies, Advaxis said in its press release issued on Wednesday, Dec. 16.
These drugs are called ADXS-PSA, admilogen filolisbac, and ADXS-HER2, which are all immunotherapies for different types of cancer and have been classified as investigational new drug.
According to Advaxis, a biotech company that specializes in immune therapy, the FDA had issued a clinical hold of these three drugs based on their safety. The FDA is an agency that screens drug applications based on their effectiveness and safety through results of clinical trials, peer reviews, and other clinical and patient information.
Advaxis received a clinical hold notification two months ago, and in response, they complied with the FDA recommendations, which included implementing measures for risk mitigation and patient surveillance. Now that the clinical hold has already been lifted, the company can now proceed with their clinical trials.
These drugs also use the company's proprietary technology called Listeria monocytogenes (Lm), a kind of bacteria that is engineered by the lab to become an immunotherapy agent.
Formerly known as ADXS-HPV, axalimogene filolisbac is intended to treat cancers that are associated with human papilloma virus (HPV), some strains of which can cause cervical cancer and throat cancer. This drug may be used to treat cervical cancer that has already become invasive, anal cancer, and cancer of the head and neck. Based on the initial clinical trial, the drug has shown promise in extending survival of the patient and positive tumor response whether used alone or with chemotherapy. The drug has already received an orphan drug designation in the European Union for anal cancer.
ADXS-PSA, on the other hand, is an immune therapy drug for those with castration-resistant prostate cancer that has already metastasized while ADXS-HER2 is for breast cancer patients with HER2 expression. Aside from humans, ADXS-HER2 can also be beneficial for animals like dogs which may develop osteosarcoma or cancer of the bone.
