Message #15 From:
NewsBot Date: December 19, 2006 06:58:00 AM
ADXS News Advaxis Partners with Gynecologic Oncology Group for Phase II Study of Company's Lead Cervical Cancer Vaccine
NORTH BRUNSWICK, N.J.--(BUSINESS WIRE)--Advaxis, Inc. (OTCBB: ADXS) has received confirmation that the
Gynecologic Oncology Group (GOG), a therapeutic clinical research group
of the National Cancer Institute (NCI) has agreed to conduct and help
fund a future Phase II trial of Lovaxin C. This trial is expected to
begin following completion of the Company’s
current Phase I/II trial. To date, Advaxis has completed enrollment and
dosing of the first two of four cohorts consisting of patients diagnosed
with advanced, recurrent or progressive cervical cancer. Review by an
independent safety panel has found that this assessment, the first in
humans, of a modified Listeria-based live vaccine is safe. Dosage
escalation is ongoing.
Dr. John Rothman, Vice President of Clinical Development for Advaxis
said, “The GOG is an extremely competent and
experienced group of clinical researchers. Their interest in
collaborating with Advaxis is very encouraging. The GOG has a
thirty-year history of facilitating the development of many therapeutic
agents that were once novel and today are well accepted as effective
drugs. Our collaboration with this excellent research group will enable
us to objectively demonstrate the therapeutic efficacy of our Lovaxin C
vaccine for the treatment of women with cervical cancer.”
The primary endpoint of the Company’s current
Phase I/II is to establish a maximal safe dose of Lovaxin C. To date
side effects have included transient mild to moderate fever and chills,
and transient nausea, all of which usually resolve within hours of
dosing. Additionally, upon the completion of the Company’s
Phase I/II Lovaxin C clinical trial Advaxis expects to continue its
program in cervical cancer and diseases related to the human papilloma
virus (HPV), as well as other clinical programs addressing areas such as
breast cancer in parallel with the GOG program, when finalized.
Based on over a decade of work in the laboratory of Dr. Yvonne Paterson
at the University of Pennsylvania, the Company's broadly enabling Listeria
technology platform uses modified Listeria monocytogenes to
deliver a tumor-specific antigen fusion protein. Listeria has the
ability to generate a robust immune response and produce an unusually
strong and effective therapeutic immune response to existing cancers and
other diseases affecting many related immune mechanisms simultaneously
and in an integrated fashion. Advaxis’Listeria-based
technology not only generates an unusually profound cytotoxic immune
response capable of killing cancer cells, but the Company’s
proprietary antigen fusion protein technology minimizes the suppressive
effects of regulatory T cells that appear to inhibit many vaccines, and
also creates a local tumor environment conducive to the therapeutic
effects of the activated tumor killing cells.
Unlike current products on the market, which are ineffective in women
already infected with HPV, which causes cervical cancer, Lovaxin C is
designed to treat women who have already developed cervical cancer as a
result of the HPV infection.
About GOG
The GOG is one of the NCI’s funded cooperative
cancer research groups and the only group which focuses its research on
women with pelvic malignancies, such as cancer of the ovary, uterus, and
cervix. The GOG’s main objective is to test
new ideas for prevention of female pelvic malignancies and management of
patients with such malignancies. Currently over 3,300 patients are
registered each year to GOG research trials. To date, GOG has completed
over 300 clinical trials and contributed over 550 manuscripts to the
peer reviewed medical literature.
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.
