Advaxis wins European patent case involving Lovaxin-C vaccine

Jan 15 2009

The European Patent Court in Munich, Germany has ruled in favor of Advaxis Incorporated and reversed a patent challenge made by Anza Therapeutics, Inc., formerly Cerus Corp.

The Court's ruling is final and can not be appealed.

The challenge was made against elements of a patent filed, and subsequently published in 1994, by Dr. Yvonne Paterson, scientific founder of Advaxis. The patent describes the use of bacteria to deliver an antigen and generate an anti-tumor immune response.

Executive VP of Science and Operations Dr. John Rothman commented, "Following the completion of Advaxis' Phase I clinical trial in recurrent metastatic cervical cancer in which the agent, Lovaxin C, was shown to be administered safely to late stage cancer patients, as well as the FDA's permission to conduct a Phase II trial in the US in patients with cervical intraepithelial neoplasia (CIN), the precursor condition to cervical cancer, Advaxis has again confirmed its position as the leading company in the field of therapeutic live attenuated bacterial vaccines."

Dr. Paterson, a microbiologist and immunologist, created the field of live Listeria therapeutics at the University of Pennsylvania. Advaxis has licensed this technology exclusively from the University.

The Advaxis patent portfolio contains over 79 US and international patents issued, and applications written by the Company and the Paterson laboratory on multiple compositions, methods and uses for therapeutic Listeria vaccines.

"This decision confirms the innovative work and inventions of Dr. Paterson" said Advaxis CEO and Chairman Thomas A. Moore. "Given our extensive body of pre-clinical scientific data and our early human clinical data, we look forward to establishing the efficacy of our technology in a variety of cancer indications."

About Advaxis, Incorporated

Based in North Brunswick, New Jersey, Advaxis is developing proprietary Listeria monocytogenes (Lm) cancer vaccines based on technology developed by Dr. Yvonne Paterson, Professor of Microbiology at the University of Pennsylvania and Chairperson of Advaxis' Scientific Advisory Board. Advaxis is developing attenuated live Listeria-based vaccines that deliver engineered tumor antigens, which safely stimulate multiple simultaneous immunological mechanisms to fight cancer.

Advaxis' lead Listeria vaccine candidate, Lovaxin-C, targets human papilloma virus (HPV)-associated cancers such as cervical and head and neck. Current Lm vaccines in development target prostate, breast, ovarian and other cancers. Recently, Advaxis completed a Phase I clinical trial of Lovaxin-C. A Phase II clinical trial is planned for patients with cervical intraepithelial neoplasia (CIN). The Lm platform also has applications in the fields of infectious disease and autoimmune disorders.

For further information on the Company, please visit: www.advaxis.com.

About the Lovaxin-C Vaccine

Advaxis' technology platform uses modified Listeria monocytogenes to deliver a tumor-specific antigen fusion protein. Bioengineered Listeria that are attenuated and secrete Advaxis' proprietary fusion protein, have the ability to generate a robust immune response, break immune tolerance to cancer and produce an unusually strong and effective multi-level therapeutic immune response to existing cancer and other diseases.

Advaxis' Listeria-based technology is based on over a decade worth of work by Dr. Yvonne Paterson in her laboratory at the University of Pennsylvania. The Company's proprietary antigen fusion protein technology, stimulates innate immunity, both arms of the adaptive cellular immune system, suppresses regulatory T-cells that inhibit many vaccines in the function of activated tumor-killing cells and has other anti-tumor effects.

Unlike prophylactic vaccines, Lovaxin-C was designed to treat women who have already developed cervical cancer as a result of contracting an HPV infection, which is the most prevalent sexually transmitted disease in the US. Current products on the market are ineffective in treating HPV-infected women.