CDC, ZKBS classifies Advaxis Agents as non-pathogenic materials

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has received affirmation by the Public Health Service of the U. S. Centers for Disease Control and Prevention (the "CDC") and the Zentrale Kommission für die Biologische Sicherheit (the "ZKBS"), the Central Commission for Biological Safety in Germany, that Advaxis strains, constructs and immunotherapies (the "Advaxis Agents") have been attenuated to the point that they are classified as non-pathogenic materials for handling and shipment. This is not the same as an assessment of safety for medical use by the FDA.

The CDC has determined that Advaxis Agents can be transported into and throughout the U.S. as non-pathogenic consistent with the definition of a Biosafety Level 1 classification (BSL-1), which applies to "well-characterized agents that are not consistently known to cause disease in healthy adult humans and are of minimal potential hazard to laboratory personnel and the environment." Advaxis Agents are manufactured in Germany and the ZKBS has granted them a Risk Group 1 classification (RG1), which are "agents not associated with disease in healthy adult humans." In addition, clinical and/or research sites may submit requests for a 'reduction in containment" from the CDC Office of Biotechnology Activities, which if granted can simplify both laboratory and human clinical handling procedures significantly.