Advaxis Files Investigational New Drug Application with U.S. Food and Drug Administration
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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 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
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.
The Investor Relations Group
212-825-3210
Investor Relations
Conrad F. Mir
conrad@investorrelationsgroup.com
or
Christine Berni
christine@investorrelationsgroup.com
or
Public & Media Relations
Janet Vasquez
janet@investorrelationsgroup.com
or
Hayden Lynch
hayden@investorrelationsgroup.com
Copyright Business Wire 2008
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