PRINCETON, N.J.--(BUSINESS WIRE)-- 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.
Advaxis Agents can now be transported between production, clinical and/or research sites in the U.S. and Germany without import permits. For additional information on these classifications, please visit these websites: CDC’s glossary of terms, the CDC Biosafety website and Germany’s Federal office for Consumer Protection and Food Safety, Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL).
About the U.S. Center for Disease Control
The U.S. Center for Disease Control (CDC) has been dedicated to protecting health and promoting quality of life through the prevention and control of disease, injury and disability. We are committed to programs that reduce the health and economic consequences of the leading causes of death and disability, thereby ensuring a long, productive, healthy life for all people. For more information, please visit their website at http://www.cdc.gov.
About the Zentrale Kommission für die Biologische Sicherheit
The Zentrale Kommission für die Biologische Sicherheit (ZKBS), the German Central Commission for Biological Security, evaluates genetically engineered organisms for their potential impact on humans, animals and the environment. ZKBS scientists are appointed by the Federal Ministry of Food, Agriculture and Consumer Protection. The organization is administered by Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL), the Federal office for Consumer Protection and Food Safety. For additional information please visit: the BVL website.
About Advaxis, Inc.
Advaxis is a biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Our novel platform technology generates a more comprehensive immune response by serving as its own adjuvant, directing antigen presentation, increasing tumor infiltrating killer T-cells, and decreasing Tregs/MDSCs in the tumor. Today, the Company has over fifteen (15) distinct constructs in various stages of development, directly developed by the Company and through strategic collaborations with recognized centers of excellence such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, and the Department of Homeland Security among others. Additional information can be found at: advaxis.com | facebook | twitter | LinkedIn
Certain statements contained in this press release are forward-looking statements that involve risks and uncertainties. The statements contained herein that are not purely historical are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements deal with the Company’s current plans, intentions, beliefs and expectations and statements of future economic performance. Forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results in future periods to differ materially from what is currently anticipated. Factors that could cause or contribute to such differences include those discussed from time to time in reports filed by the Company with the Securities and Exchange Commission. The Company cannot guarantee its future results, levels of activity, performance or achievements.
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