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) August 29, 2005
|
Advaxis,
Inc.
|
|
(Exact
name of registrant as specified in its
charter)
|
|
Colorado
|
00028489
|
84-1521955
|
|
(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
|
|
212
Carnegie Center #206, Princeton, New Jersey
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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)
895-7150
|
(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
August
29, 2005, the Registrant announced that it successfully completed its
pre-clinical toxicology studies of Lovaxin C, its Listeria Cancer Vaccine,
for
treatment of cervical, head and neck cancers. The results from these studies
complete the toxicology package necessary for the initiation of its Phase
I/II
study in cervical cancer patients. 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 August 29, 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.
| Dated: August 31, 2005 | ||
| ADVAXIS, INC. | ||
| |
|
|
| By: | /s/ J. Todd Derbin | |
|
Name: J. Todd Derbin |
||
| Title: President and Chief Executive Officer | ||
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Exhibit
99.1
Advaxis’
Listeria Cancer Vaccine Shows Strong Safety Profile In Toxicology
Studies
August
29, 2005 9:00 AM
Princeton,
NJ, (BUSINESS WIRE) Advaxis, Inc (OTCBB: ADXS) announced today that
it
has successfully completed its pre-clinical toxicology studies of Lovaxin C,
its
Listeria Cancer Vaccine, for treatment of cervical and head and neck cancers.
The results from these studies complete the toxicology package necessary for
the
initiation of its Phase I/II study in cervical cancer patients. This trial
will
be the first-in-man assessment of a Listeria
monocytogenes based
live cancer vaccine.
Toxicology
and assay assessments were performed at Stillmeadow Inc, Lark Laboratories
and
Nova Laboratories in conformance with the Good Laboratory Practice procedures
that are required by U.S. and European regulatory authorities. Toxicology
testing was performed on mice in both single and repeated dosing regimens.
Commenting
on the completion of this work, John Rothman, Ph.D, Advaxis’ Vice President of
Clinical Development stated, "We are pleased to report the successful completion
of our preclinical toxicology program and the safety of Lovaxin C. As we had
expected, Lovaxin C, which is made from attenuated Listeria, has been proven
to
be far less toxic than wild type Listeria monocytogenes. Further, no evidence
of
toxicity was reported at levels that correspond to the doses in our upcoming
human clinical studies. This third-party data confirms the results we had
already observed in our laboratories. It is interesting to note that we tested
the safety of Lovaxin C in a species of mouse known to be most sensitive to
Listeria toxicity, thus assessing toxicity in the worst case. Additionally,
we
have confirmed the susceptibility of Lovaxin C to many common antibiotics,
which
assures us of the ability to maximize efficacy with regimens that are completely
safe, even in immunocompromised cancer patients."
J.
Todd
Derbin, Chief Executive Officer of Advaxis commented, “Achieving this milestone
takes us one step further with our Listeria based cancer vaccines. Further,
given that our Company is based on platform technology and that Lovaxin will
be
used to treat a variety of other types of cancers, we find this news especially
encouraging.”
Advaxis
plans to initially develop Lovaxin C for patients with cervical and head and
neck cancers, which both express the antigen HPV-E7, against which Lovaxin
C
targets an unusually strong cytotoxic immune response.
A
phase
I/II study for late-stage cervical cancer patients is planned for late 2005
followed by Phase II protocols in both cervical and head and neck cancers in
late 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: | ||
| J. Todd Derbin | Jennifer K. Zimmons, Ph.D. | |
| CEO & President | Investor Relations | |
| Advaxis, Inc. | Strategic Growth International | |
| 212 Carnegie Center | 150 East 52nd St., 22nd Fl. | |
| Princeton, NJ 08540 | New York, NY 10021 | |
| (609) 895 7150 | (212) 838-1444 | |
| derbin@advaxis.com | jzimmons@sgi-ir.com |
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