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) March 7, 2006
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Advaxis,
Inc.
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(Exact
name of registrant as specified in its
charter)
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Colorado
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00028489
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84
- 1521955
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(State
or other jurisdiction of incorporation)
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(Commission
File Number)
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(IRS
Employer Identification No.)
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Technology
Center of New Jersey
675
Route 1, Suite 119, North Brunswick, New Jersey
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08902
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code (201)
750-2347
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(Former
name or former address, if changed since last
report.)
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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):
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
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Item
8.01. Other
Events
See
Registrant’s press release attached hereto as Exhibit 99.1. for information as
to the receipt of approvals from the Ministry of Health of Israel Ministry
of
Health of Mexico to conduct in those countries pre-clinical Phase I/II studies
as to the safety of its Lovaxin C vaccine which is directed towards the
treatment of cervical cancer.
Item
9.01. Financial
Statements and Exhibits
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a)
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Not
applicable.
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b)
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Not
applicable.
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c)
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Exhibits
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99.1.
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Press
Release, dated March 7, 2006
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2
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: March
10,
2006
| ADVAXIS, INC. | ||
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| By: | /s/ Roni Appel | |
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Name: Roni
Appel
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| Title: Chief Executive Officer | ||
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EXHIBIT
99.1
Advaxis
Inc. Announces Approvals of Israeli and Mexican Regulators to Commence Clinical
Study of its Listeria Cancer Vaccine Candidate for Cervical
Cancer
North
Brunswick, NJ — Advaxis
Inc. (OTCBB: ADXS)
announced that it has received the approval of the Ministry of Health of Mexico
and, subject to the approval of the ethical committee of Hadassah Hospital,
the
approval of the Ministry of Health of Israel to commence in those countries
a
Phase I/II trial study of Lovaxin C, a Listeria-based vaccine, directed towards
the treatment of cervical cancer. These approvals follow a recently announced
approval by the Serbian Agency for Drugs and Medicinal Devices to conduct a
study at the Institute for Oncology and Radiology in Belgrade.
The
study
is the first-in-man study by Advaxis in its proposed development of a new class
of cancer therapy using Advaxis proprietary delivery system, which uses live
Listeria monocytogenes
to
deliver an antigen fusion protein to generate an immune response characterized
by very high levels of tumor infiltrating cytotoxic T cells.
This
Phase I/II trial of Lovaxin C will be conducted simultaneously at the facility
in Belgrade, two facilities in Mexico and, subject to the approval by the
Hadassah Hospital ethical committee, at the hospital in Jerusalem, with results
expected in the second half of 2006. The company plans to submit the test
results to the FDA.
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 is entering
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.
Company
Contact:
Advaxis,
Inc.
Roni
Appel, 201-750-2347
Investor
Relations/Public Relations Contact:
Investor
Relations Group
Erik
Lux/Adam Holdsworth, Investor Relations
Janet
Vasquez, Public Relations
212-825-3210
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