Advaxis Files Investigational New Drug Application with U.S. Food and Drug Administration
Lovaxin C Phase II Study and Protocol for Cervical Intraepithelial Neoplasia
A Randomized, Single Blind Placebo Controlled Phase 2 Study to Assess the Safety, Efficacy, and Immunogenicity of Vaccination with Listeria monocytogenes Expressing Human Papilloma Virus Type 16 E7 (Lovaxin C) for the Treatment Cervical Intraepithelial Carcinoma Stage 2/3
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--Advaxis Inc., (OTCBB: ADXS, http://www.advaxis.com.), a developmental biotechnology company, 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 trial is a potential major step forward in our clinical program”
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.”
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 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.
For further information on the Company, please visit: http://www.advaxis.com.
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 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’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.
Unlike prophylactic vaccines, Lovaxin C was designed to treat women who have already developed 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 products on the market are ineffective in treating HPV-infected women.
For further information on Lovaxin C, please visit: http://www.advaxis.com/lc.htm
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.