Advaxis files investigational new drug application for Lovaxin C

May 20 2008

Advaxis Inc. completed its filing of a new investigational new drug ("IND") application with the U.S. Food and Drug Administration ("FDA"). This filing follows the successful completion of a Phase I study overseas.

This application includes a Phase II protocol for Lovaxin C, Advaxis' lead drug candidate, for the treatment of Cervical Intraepithelial Neoplasia ("CIN") to be conducted in the US. The filing requires a certificate of analysis for the Company's second clinical batch, which is currently being made and is anticipated to be complete within the next few weeks. The CIN study is scheduled to begin this summer pending the completion of the IND and approval by the FDA.

CIN is a cervical condition caused by a sexually transmitted virus called the Human Papilloma Virus ("HPV") that can lead to invasive cervical cancer, if not diagnosed properly and left untreated. Currently, the standard treatment for late stage CIN is surgery to preclude invasive cancer, and there are approximately 250,000 cases of CIN treated this way in the US annually. Recent new vaccines can prevent occurrence of CIN if administered before HPV is contracted, but do not treat the disease itself.

"This trial is a potential major step forward in our clinical program," commented Advaxis Chairman and CEO Tom Moore. "Lovaxin C, our lead drug candidate, and our Listeria platform is quickly drawing the attention of such notable organizations within the medical community as the American Association for Cancer Research ("AACR"), the Cancer Research Institute ("CRI") and, most recently, the Gynecologic Oncology Group ("GOG"). We are encouraged by our Phase I results, and our ability to generate novel immunotherapies with considerable activity in animal models. Additional clinical trials with Lovaxin C and the introduction of new immunotherapies into clinical trials are planned."

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 to fight cancer safely.

Advaxis' lead Listeria vaccine candidate, Lovaxin C, targets 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/II clinical trial of Lovaxin C. A Phase II clinical trial is planned for patients with cervical intraepithelial neoplasia ("CIN"). The company intends to start this study in CIN I/II patients in the summer of 2008. The Lm platform also has applications in the fields of infectious disease and autoimmune disorders.