FDA News

Advaxis Incorporated Provides Complete Response to FDA's Questions

(Oct 15, 2008)-- Advaxis Incorporated 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.

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 the Company, please visit: http://www.advaxis.com.

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