Unassociated Document
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
January
13, 2009
(Date of
Earliest Event Reported)
Advaxis,
Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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00028489
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02-0563870
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(State or other
jurisdiction
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(Commission
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(IRS
Employer
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of
incorporation)
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File
Number)
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Identification
No.)
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Technology
Centre of New Jersey
675
Rt. 1, Suite B113
North
Brunswick, N.J. 08902
(Address
of principal executive offices)
(732) 545-1590 (Registrant’s
telephone number, including area code)
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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):
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
The
European Patent Office in Munich, Germany Reverses Technology Patent
Challenge
The
European Patent Office (EPO) Board of Appeals in Munich, Germany has ruled in
favor of The Trustees of the University of Pennsylvania and its exclusive
licensee Advaxis, Inc. (OTCBB: ADXS) and reversed a ruling that revoked a
technology patent that had resulted from an opposition filed by Anza
Therapeutics, Inc., formerly Cerus Corp (NASDAQ: CERS). The ruling of the EPO
Board of Appeal is final and can not be appealed.
The
granted claims, the subject matter of which was discovered by Dr. Yvonne
Paterson, scientific founder of Advaxis, is directed to the first use of a
recombinant bacteria expressing a tumor antigen for the treatment of patients
with cancer.
Executive
VP of Science and Operations Dr. John Rothman commented, "Following the
completion of Advaxis’ Phase I clinical trial in recurrent metastatic cervical
cancer in which the agent, Lovaxin C, was shown to be administered safely to
late stage cancer patients, as well as the FDA’s permission to conduct a Phase
II trial in the US in patients with cervical intraepithelial neoplasia (CIN),
the precursor condition to cervical cancer, Advaxis has again confirmed its
position as the dominant and leading company in the field of therapeutic live
attenuated bacterial vaccines."
Dr.
Paterson, a microbiologist and immunologist, created the field of live Listeria therapeutics at
the University of Pennsylvania. Advaxis has exclusively licensed this technology
from the University.
The
licensed patent portfolio of Advaxis contains over 79 US and international
issued patents and pending patent applications, directed to compositions,
methods and uses for therapeutic Listeria vaccines.
“This
decision confirms the innovative work and inventions of Dr. Paterson” said
Advaxis CEO and Chairman Thomas A. Moore. “Given our extensive body
of pre-clinical scientific data and our early human clinical data, we look
forward to establishing the efficacy of our technology in a variety of cancer
indications.”
About
Advaxis, Incorporated
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 attenuated live Listeria-based
vaccines that deliver engineered tumor antigens, which safely stimulate
multiple simultaneous immunological mechanisms to fight cancer.
Advaxis’
lead Listeria vaccine candidate, Lovaxin-C, targets human papilloma virus
(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 clinical trial of Lovaxin-C. A Phase II clinical
trial is planned for patients with cervical intraepithelial neoplasia
(CIN). The Lm platform also has applications in the fields of
infectious disease and autoimmune disorders.
For
further information on the Company, please visit: www.advaxis.com.
About
the Lovaxin-C Vaccine
Advaxis’
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 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 an 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: 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.
For
Further Information:
Conrad
Mir
Advaxis,
Inc.
732.545.1590
(Office)
732.545.1084
(FAX)
conradmir@advaxis.com
www.advaxis.com
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, Registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
Dated:
January 16, 2009
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Advaxis,
Inc.
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By:
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/s/ Thomas
A. Moore |
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Name: |
Thomas
A. Moore
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Title: |
Chief
Executive Officer
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