UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of
The
Securities Exchange Act of 1934
Date
of
Report (Date of earliest event reported) September 28, 2005
|
Advaxis,
Inc.
|
|
(Exact
name of registrant as specified in its
charter)
|
|
Colorado
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00028489
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84
- 1521955
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(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
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(IRS
Employer Identification No.)
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212
Carnegie
Center #206, Princeton, NJ
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08546
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(Address
of principal executive offices)
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(Zip
Code)
|
Registrant’s
telephone number, including area code (609)
497-7555
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|
|
(Former
name or former address, if changed since last
report.)
|
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act
(17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange
Act
(17 CFR 240.13e-4(c))
Item
8.01. Other
Events
On
September 26, 2005, the Registrant announced that a significant publication
of
work performed by Dr. Yvonne Paterson, scientific founder of the Registrant,
has
been published this week in the Journal of Immunology (JI, 2005, 175:3663-73)
which demonstrates that a live Listeria
cancer
vaccine is capable of eradicating existing rapidly growing breast tissue
tumors
in mice. See
Registrant’s press release attached hereto as Exhibit 99.1.
| Item 9.01. |
Financial
Statements and Exhibits
|
| a) |
Not
applicable.
|
| b) |
Not
applicable.
|
| c) |
Exhibits
|
| 99.1. |
Press Release, dated September 26,
2005
|
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SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| ADVAXIS, INC. | ||
| |
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Dated: September
28, 2005
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By: | /s/ J. Todd Derbin |
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Name: J. Todd Derbin |
||
| Title:
President
and Chief
Executive
Officer
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||
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EXHIBIT
99.1
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Press
Release
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Source:
Advaxis, Inc.
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Advaxis’
Listeria
Cancer vaccine results in complete regression of rapidly growing breast
tumors
PRINCETON,
NJ--(BUSINESS WIRE)
-- September
26, 2005 -- Advaxis, Inc. (OTCBB: ADXS)
today
announced that a significant publication of work performed by Dr. Yvonne
Paterson, scientific founder of Advaxis, has been published this week in the
Journal of Immunology (JI, 2005, 175:3663-73) which demonstrates that a live
Listeria
cancer
vaccine is capable of eradicating existing rapidly growing breast tissue tumors
in mice. Listeria
vaccine
treatment was found to be significantly more effective than comparable DNA
vaccines, even though the DNA vaccines were given before the implementation
of
tumors and the Listeria
vaccines
were given after tumors were palpable. The profound immunologic response to
a
series of five Listeria
vaccines
that were constructed to assess the efficacy of novel fragments of the HER-2/neu
antigen revealed the ability of novel immune recognition sites used in these
agents to arrest tumor progression in all cases and achieve regression that
included complete regression in many cases.
"We
found
that we can stop the tumor from growing out to 100 days, at which time we
stopped measuring since this is a long time for experiments of this type,"
said
Dr. Paterson. “The tumors stopped growing or went completely away."
“This
finding again confirms the powerful ability of Listeria
vaccines
to eradicate growing tumors in another tumor type - breast-like cancer, and
also
provides a new model for the development of novel and previously unknown
therapies to stop and possibly reverse cancer growth based upon Listeria
live
vaccine vectors”, commented Dr. John Rothman, VP Clinical Development at
Advaxis. “The ability to cause a complete in
vivo
regression of a pre-existing rapidly growing tumor, that if left untreated,
results in death within weeks, is very significant, and provides additional
support for using Listeria
vectors
for inducing meaningful therapeutic results in a number of tumor
types”.
“Like
many immunological approaches, Listeria
vaccines
have been shown to stimulate innate immunity, adaptive immune responses
including the activation of dendritic cells, and to induce a cascade of
compounds made by the body that are associated with therapeutic responses.
It
is, however, because Listeria
is an
agent that infects antigen presenting cells, and because Dr. Paterson has found
ways to modify the presentation of antigen by Listeria
constructs to the immune system, that Listeria
vaccines
exert an extremely powerful stimulatory direct effect upon the generation of
tumor killing cytotoxic T cells in ways that result in therapeutic responses
not
seen heretofore,” Dr. Rothman said. “It is the goal of many immuno-therapeutic
approaches to activate cytotoxic T cells. Listeria
vaccines
have been shown to be arguably the most effective method for generating this
immune response.”
Dr.
Paterson’s work is the basis for Advaxis’ technology. These new findings provide
substantial support for Lovaxin B, Advaxis’Listeria
cancer
vaccine for the treatment of breast cancer and other tumors which express the
HER-2 antigen. Advaxis’ first Listeria
cancer
vaccine, Lovaxin-C for cervical cancer, is scheduled to begin a Phase I/II
clinical trial within two months. Advaxis plans to initiate a Phase I/II
clinical trial in Lovaxin B in year 2006.
About
Advaxis:
Advaxis
is based in Princeton, New Jersey. Advaxis is developing proprietary Listeria
cancer vaccines based on the vaccine technology developed by Dr. Yvonne Paterson
in the Department of Microbiology at the University of Pennsylvania. Advaxis
is
developing therapeutic cancer vaccines that enhance the immune system’s
cancer-fighting abilities. Advaxis, through its proprietary Listeria monocytogenes
based
system, is utilizing 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 based on the use of attenuated bacteria Listeria monocytogenes,
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 is entering a Phase I/II clinical trial in late 2005. The Listeria
platform
will also have applications in the fields of infectious disease and autoimmune
disorders.
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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.
Contact:
Advaxis, Inc.
J. Todd Derbin, 609-895-7150
derbin@advaxis.com
or
Strategic Growth International
Investor Relations:
Jennifer K. Zimmons, Ph.D.,212-838-1444
jzimmons@sgi-ir.com
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