Message #11 From:
NewsBot Date: September 25, 2006 05:30:00 AM
ADXS News Advaxis Meets with FDA Regarding Phase II of Lovaxin C
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--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. 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.
