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): December 15, 2009
ADVAXIS,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
(State or
other jurisdiction of incorporation)
00028489
|
02-0563870
|
(Commission
File Number)
|
(IRS
Employer Identification Number)
|
Technology
Centre of New Jersey
675
Rt. 1, Suite B113
North
Brunswick, N.J. 08902
(Address
of principal executive offices)
Registrant’s
telephone number, including area code: (732) 545-1590
Not
applicable
(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:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
¨ 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
December 15, 2009, Advaxis, Inc. (the “Company”) issued a press release
regarding its planned collaboration with the National Cancer Institute’s
Gynecological Oncology Group in a Phase II clinical trial of the Company’s drug
candidate ADXS11-001. A copy of the press release, which is attached
as Exhibit 99.1 to this Current Report, is incorporated herein by
reference.
Item
9.01 Financial Statements and Exhibits.
99.1
|
Advaxis,
Inc. press release, dated December 15,
2009.
|
SIGNATURES
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: December
15, 2009 |
Advaxis, Inc. |
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|
|
|
|
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By:
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/s/ Thomas
A. Moore |
|
|
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Thomas
A. Moore |
|
|
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Chief
Executive Officer
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EXHIBIT
INDEX
Exhibit
No.
|
Document
Description
|
99.1
|
Advaxis,
Inc. press release, dated December 15,
2009.
|
FOR IMMEDIATE
RELEASE
ADVAXIS
ANNOUNCES PHASE II TRIAL COLLABORATION
WITH
THE NATIONAL CANCER INSTITUTE
Gynecologic
Oncology Group to Study ADXS11-001 in Sixty-Patient Study
North Brunswick, NJ - December 15,
2009 - Advaxis,
Inc., (OTCBB:
ADXS), the live, attenuated Listeria monocytogenes (Lm) vaccine company, will
collaborate with the Gynecologic Oncology Group (GOG), a collaborative research
group of the National Cancer Institute (NCI), in a multicenter, Phase II
clinical trial of the Company’s lead drug candidate, ADXS1 1-001 in the
treatment of advanced cervix cancer in women who have failed prior cytotoxic
therapy.
This
Phase II trial will be conducted by GOG investigators and largely underwritten
by the NCI. The study’s patient population – a very sick and rapidly progressive
patient population for whom no therapy has been found to be effective – will be
the same patient population that was treated in Advaxis Phase I trial of ADXS1
1-001.
Advaxis
will contribute the study drug and some funds to the cost of the trial,
including the translational clinical immunology research. Advaxis will update
its IND and file the final protocol with FDA before the study
begins.
In an
Advaxis Phase I clinical trial, it was found that multiple doses of the agent
were safely administered to this patient population at two (2) different dose
levels and that the side effect profile, comprised of a flu-like syndrome, was
consistent with strong immune stimulation. Although this firstin-human
trial was not powered for efficacy, it was observed that the response rate and
survival data compared favorably with historical controls. The new study will
investigate this response with greater statistical power. The Phase I trial
results were published earlier this year in Vaccine (Vaccine. 2009, 27
3975–3983).
Advaxis
has separately announced its plans of Phase II studies of cervical cancer and
cervical intraepithelial neoplasia (CIN), which are anticipated to begin dosing
shortly.
About
the ADXS11-001 Immunotherapy
ADXS11-001
is a therapeutic vaccine that treats human papilloma virus (H PV) related
tumors. Unlike marketed prophylactic vaccines that require treatment prior to
exposure to the virus, A DX S1 1-001 treats patients who have already developed
cancer as a result of HPV infection. Today, HPV is the most prevalent sexually
transmitted disease in the US and the cause of cervix cancer, 40% of head and
neck cancer, as well as penile, vulvar and anal cancer. Other clinical trials
are planned for this agent in 2010, including a trial in cervical
intraepithelial neoplasia (CIN). For additional information please see www.advaxis.com.
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 Lm vaccines that deliver
engineered tumor antigens, which stimulate multiple simultaneous immunological
mechanisms to fight cancer.
In a
recent Advaxis Phase I clinical trial, a live Lm vaccine directed against
the tumor-associated antigen HPV-16-E7 was safely administered to fifteen (15)
women with advanced metastatic cancer of the cervix. Although this first trial
of an Lm vaccine in
humans was not designed or powered to prove efficacy, Advaxis believes an
efficacy signal was observed that will be further explored in two (2) planned
Phase II trials in the US and India in cervical cancer and its predecessor
condition, cervical intraepithelial neoplasia (CIN). Advaxis now has nine (9)
distinct cancer fighting constructs in various stages of development, both
directly and with academic collaborators. For further information on the
Company, please visit: www.advaxis.com.
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
Director,
Business Development Advaxis, Incorporated
732.545.1590
(Office)
732.545.1084
(FAX)
conradmir@advaxis.com
www.advaxis.com