News
September 25, 2006
Advaxis Meets with FDA Regarding Phase II of Lovaxin C
North Brunswick, NJ � September 25, 2006 -- Advaxis, Inc. (OTCBB: ADXS) has conducted a pre- IND meeting with the U.S. Food and Drug Administration (FDA) regarding its two planned Phase II studies for its lead product Lovaxin C, a live Listeria vaccine for the treatment of cervical as well as head and neck cancers. The FDA has reviewed information provided by the Company on its methods, procedures and results to date, and provided guidance for the submission of an investigational new drug (IND) application and future product development. The Company has proposed Phase II trials in cervical and head and neck cancers that are each expected to consist of 60 early stage cancer patients. The objectives of these trials are to assess the regimens for the safety and efficacy of Lovaxin C. In both trials the Company will measure time to progression and survival endpoints, immuno-genetic ability, and safety parameters. Pre-clinical data for Lovaxin C has shown an extremely efficacious immune response to tumors upon administration of the drug with an overall response rate of 100% and complete eradication of tumors in more than half of the animals tested.
"We are working closely with the FDA to ensure all requirements are met as we prepare to progress through our clinical studies and are quite pleased with the progress we have made," said Dr. John Rothman, VP Clinical Development. "We look forward to advancing Lovaxin C as well as our other cancer vaccines through the clinical trials."
Lovaxin C is currently in a Phase I/II safety trial being conducted in Serbia, Israel and Mexico with 20 patients. Thus far, this agent has been well tolerated and has revealed a good safety profile consistent with its preclinical studies. The IND application will be filed with FDA once Phase I/II has been completed.
About Advaxis
Based in North Brunswick, New Jersey, Advaxis is developing proprietary Listeria 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 Listeria monocytogenes based system, which utilizes two immunological mechanisms (Innate and Classical Immunity) to develop safer and more effective Listeria based cancer vaccines. Advaxis is the exclusive licensee of a patented broadly enabling Listeria platform technology that can elicit effective anti-tumor responses. Advaxis' lead Listeria vaccine candidate, Lovaxin C, targets cervical and head and neck cancers. Further Listeria vaccines in development target breast, ovarian and lung cancers. Advaxis has entered a Phase I/II clinical trial. The Listeria platform will also have applications in the fields of infectious disease and autoimmune disorders.
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. Forwardlooking 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.
Company Contact:
Advaxis, Inc.
Roni Appel, 201-750-2347
Investor Relations/Public Relations Contact:
Investor Relations Group:
Antima "Taz" Sadhukhan
212-825-3210
Media Contact:
Janet Vasquez, Public Relations
212-825-3210