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
5, 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
|
|
(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)
|
(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
January 6, 2009, Advaxis, Inc issued a press release regarding its Phase II
Clinical Trail “Hold” Lifted.
A
copy of the press release is attached as Exhibit 99.1 to this Current Report and
is incorporated herein by this reference.
Item
9.01 Financial Statements and
Exhibits
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99.1
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Advaxis,
Inc. press release, dated January 6,
2009
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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 6, 2009
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Advaxis,
Inc.
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||
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By:
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/s/
Thomas A. Moore
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Name:
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Thomas
A. Moore
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Title:
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Chief
Executive Officer
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Exhibit
99.1
CORPORATE
NEWS
ADVAXIS’
PHASE II CLINICAL TRIAL “HOLD” LIFTED
_____________________________
U.S.
FDA Approves Investigational New Drug Application for
Phase
II for Cervical Intraepithelial Neoplasia Grade 2/3 Clinical Trial
North Brunswick, NJ – January 6, 2009
– Advaxis
Inc (OTCBB:
ADXS), a biotechnology company, received permission from the U. S. Food
and Drug Administration (FDA) to test its lead drug candidate, Lovaxin C, in
patients with grade 2/3 cervical intraepithelial neoplasia
(CIN). With this approval of the Investigational New Drug (IND)
application for Lovaxin C, the FDA “HOLD” on Advaxis’ clinical program has been
lifted.
Advaxis
submitted its IND application to the FDA in May 2008, which outlined the
proposed protocol for a Phase II clinical trial safety study targeting CIN – a
precursor condition to cervical cancer, commonly diagnosed by PAP
smears. The proposed trial, unlike Advaxis’ Phase I cervical cancer
trial, will target the disease at a much earlier stage of development and
recruit CIN patients living in the U. S. that are otherwise healthy. Due to the
different patient population, the FDA requested more information to support the
safety of Lovaxin-C and the methods used in its manufacture, which prompted the
clinical trial “HOLD.”
Regarding
the FDA’s acceptance of the Company’s IND application, Advaxis’ Executive
Director of Product Development, Dr. Christine Chansky, MD, JD, said, “Advaxis’
clinical and scientific team comprehensively responded to the FDA’s
questions. There were well over 700 pages of documentation submitted,
which included results from our Phase I clinical trial study as well as animal
research conducted specifically for the response. It was a great job by the team
and a fine start to our regulatory relationship with the FDA. The FDA
has requested additional information regarding our manufacturing processes as
they develop, which we will provide as the processes are
validated.”
Addressing
the CIN trial’s expectations, Advaxis’ Executive VP of Science & Operations
Dr. John Rothman commented, “This study is a blinded, randomized and
placebo-controlled trial of sufficient size; to build upon the promising results
of our Phase I study in metastatic cervical cancer patients. In this study
however, we are treating healthier women with stronger immune systems and with
much less disease burden. We believe that this work will provide us with
meaningful support that our live, Listeria-based drug delivery system can safely
resolve CIN before it becomes invasive cervical cancer, and without the adverse
events that currently attend surgical treatment.” The Company anticipates
commencing the trial in the second or third quarter of 2009.
CIN is a
cervical condition caused by the sexually transmitted human papilloma virus
(“HPV”), which can lead to invasive cervical cancer, if not diagnosed properly
and left untreated. Recently developed vaccines can prevent disease if
administered before HPV is contracted but do not treat the disease, and cannot
be used to treat women who have already been exposed to HPV. Today, the accepted
treatment protocol for late stage CIN is surgery, which is performed to preclude
invasive cancer. Surgical treatment of CIN is associated with various adverse
events and may render the cervix incompetent to come to a full term
pregnancy.
“The
FDA’s approval of Advaxis’ IND application to conduct the first US based
clinical trial of a live Listeria monocytogenes
vaccine that secretes an LLO-tumor specific antigen fusion is a major milestone
for the Company as well as for the entire field of immunotherapy,” commented
Advaxis Inc.’s Chairman and CEO, Thomas A. Moore. “Our technology enables the
delivery of a tumor specific antigen fused to the highly adjuvant Listeria
protein, Listeriolysin O (“LLO”), which has a very powerful, anti-tumor
effect. Although we have an active clinical program in invasive
cervical cancer planned, the safety and efficacy results in the CIN indication
will enable us to pursue a U. S. market of about 250,000 patients per year; 50
times the market size of cervical cancer.”
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,
Incorporated
732.545.1590
(Office)
732.545.1084
(FAX)
conradmir@advaxis.com
www.advaxis.com