Ayala Pharmaceuticals Inc (fka ADXS)

[yessum]

March 10, 2009

ADVAXIS SUBMITS ADXS11-001 FOR ORPHAN DRUG DESIGNATION

North Brunswick, NJ – March 10, 2009 – Advaxis, Incorporated (OTCBB: ADXS), today submitted to the US Food and Drug Administration (FDA) its lead drug candidate, ADXS11-001 (formerly known as Lovaxin-C), for Orphan Drug Designation (ODD) to treat invasive carcinoma of the cervix.

Orphan Drug Designation is intended to support the clinical development of drugs to treat diseases that affect less than 200,000 people in the United States. If approved, such a designation would grant Advaxis fast-track review process as well as market exclusivity for a period of seven years. In addition, Advaxis would be eligible for direct guidance from the FDA for the design of a clinical plan to further develop the drug. By statute, the FDA must review and respond to an Orphan Drug application within sixty (60) days.

The approval time for orphan products is often considerably shorter than the approval time for other drugs. This reduced approval time is due to expedited review or accelerated approval because the drugs treat serious or life-threatening diseases. The Office of Orphan Products Development also administers a clinical research grants program, whereby researchers may compete for funding to conduct clinical trials for rare diseases and conditions.

Advaxis Chairman and CEO Thomas A. Moore commented, “Over 10,000 women a year are newly diagnosed with cervical cancer. Women with the disease who fail cytotoxic therapy have a very short survival prognosis. Our preliminary clinical data indicates our agent may improve the survival of these patients. The ODD program affords us the ability to collaborate with the FDA in a manner that provides a clear and more rapid path to market."

Advaxis Chairman and CEO Thomas A. Moore commented, “As our research team furthers our Lm platform and works on additional strains, some of which are less virulent than others, we are committed to fulfilling the potential that live Listeria-based delivery systems brings to the treatment of cancer."

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 Lm vaccines that deliver engineered tumor antigens, which stimulate multiple simultaneous immunological mechanisms to fight cancer.

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

About the ADXS11-001 Immunotherapy

Advaxis’ technology platform uses modified Listeria monocytogenes to deliver a tumor-specific antigen fusion protein. Pre-clinically, bioengineered attenuated Listeria that 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 i.e., both arms of the adaptive cellular immune system, suppresses regulatory T-cells that inhibit many vaccines in the function of activated tumor-killing cells in addition to other anti-tumor effects.

ADXS11-001 is a therapeutic vaccine, unlike currently marketed prophylactic vaccines, that treats women who have already developed cervical cancer as a result of human papilloma virus (HPV) infection; the most prevalent sexually transmitted disease in the US today. Advaxis has already filed an IND for a Phase II trial in HPV caused Cervical Intraepithelial Neoplasia (CIN), which is pre-cancerous.