Message #13 From:
Stock News Bot Date: November 7, 2006 04:00:00 AM
ADXS News Advaxis Completes Dosing and Enrollment of First Cohort of Patients in Phase I/II Cervical Cancer Vaccine Trial
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--Advaxis, Inc. (OTCBB: ADXS)
has completed the enrollment and dosing of the first cohort of patients
diagnosed with advanced, recurrent or progressive cervical cancer in its
Phase I/II clinical trial of Lovaxin C. Review by an independent safety
panel has found that this first in man assessment of a modified Listeria-based
live vaccine is safe and dosage escalation is ongoing.
The trial is designed to test 4 different doses in cohorts of 5
patients. Side effects included transient mild-moderate fever and chills
and transient nausea, all of which usually resolved within hours of
dosing. Advaxis has now begun the dosing in the second cohort. The
Company is required to have the results of each dosing from each cohort
to be reviewed by the committee prior to continuing the study and
increasing the dosage in patients. The primary endpoint of this work,
which is being conducted in Israel, Serbia and Mexico, is to establish a
maximal safe dose of Lovaxin C
“For over a decade work in the laboratory of
Dr. Yvonne Paterson and others have shown that a live Listeria
vaccine was very effective in animal models. However, whether it was
safe to use a pathogenic micro-organism as a cancer vaccine remained a
large unresolved question until now. The finding that Lovaxin C can be
administered at therapeutic levels intravenously to late-stage cancer
patients is a significant and very hopeful finding. This is a major
accomplishment for the Company,” commented
Roni Appel, President and CEO of Advaxis.
This is the first human study by Advaxis in its development of a new
class of cancer therapies using the Company’s
broadly enabling Listeria technology platform. These therapies use
modified Listeria to deliver a tumor-specific antigen fusion
protein, which have the ability to generate a robust immune response
involving simultaneous and multiple integrated immune mechanisms to
produce an unusually strong and effective therapeutic immune response to
existing cancers and other diseases.
Unlike current products on the market, which are ineffective in women
already infected with the human papilloma virus (HPV), the cause of
cervical cancer, Lovaxin C is designed to treat women who have already
developed this cancer as a result of the infection.
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 chair person 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.
