Advaxis Responds To FDA's Questions Phase II Trial Of Lovaxin C For The Treatment Of Cervical Intraepithelial Neoplasia

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 15 Oct 2008 - 5:00 PDT

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Advaxis Incorporated (OTCBB: ADXS) has provided a complete response to the FDAs questions regarding the proposed use in humans of Lovaxin C, a live Listeria vaccine directed against HPV induced disease, in the treatment of CIN. Lovaxin C is a bioengineered microbe that infects the immune system and delivers a proprietary protein comprised of an HPV antigen fused to a fragment of the Listeria protein LLO, to stimulate multiple simultaneous immune mechanisms.

About Lovaxin C Vaccine

Advaxis' Listeria technology platform uses modified Listeria monocytogenes to deliver a tumor-specific antigen fusion protein. Bioengineered Listeria that are attenuated and secrete Advaxis' proprietary fusion proteins 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's 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.

Advaxis' lead Listeria therapeutic vaccine candidate, Lovaxin C, targets human papilloma virus (HPV)-associated cancers such as cervical and head and neck. Recently, Advaxis completed a Phase I clinical trial of Lovaxin C in cervical cancer. A Phase II clinical trial is planned for patients with cervical intraepithelial neoplasia (CIN). The Company intends to start this study in CIN 2/3 grade patients in the fall of 2008, pending FDA review and approval.

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

For further information on Lovaxin C, please visit: www.advaxis.com/lc.htm

About Advaxis, Inc.

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 therapeutic cancer vaccines that enhance the immune system's cancer fighting abilities through its proprietary Lm based system, which utilizes multiple simultaneous immunological mechanisms and which has been safely administered to patients with cancer.

Aside from Lovaxin C, Advaxis has agents in pre-clinical development for prostate, breast, and other cancer types.

http://www.advaxis.com.

Forward-Looking Statements
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.