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
April
18, 2008
(Date
of
Earliest Event Reported)
Advaxis,
Inc.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
00028489
|
02-0563870
|
|
(State
or other jurisdiction
|
(Commission
|
(IRS
Employer
|
|
of
incorporation)
|
File
Number)
|
Identification
No.)
|
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
April 18, 2008, Advaxis, Inc. (“Advaxis”) (OTCBB: ADXS) issued
a
press release reporting the nationwide media attention that Advaxis’ Listeria
Monocytogenes-Based Vaccine has recently received.
A
copy of the press release is attached as Exhibit 99.1 to this Current Report
and
is incorporated by this reference.
2
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:
April 18, 2008
|
|
Advaxis,
Inc.
|
|
|
|
||
|
|
||
|
|
By:
|
/s/
Thomas A. Moore
|
|
|
Name:
|
Thomas
A. Moore
|
|
|
Title:
|
Chief
Executive Officer
|
3
FOR
IMMEDIATE RELEASE
ADVAXIS’
LISTERIA MONOCYTOGENES-BASED VACCINE
GARNERS
NATIONAL MEDIA ATTENTION
U.S.
News & World Report, Forbes, and Other Online Outlets Report on Lovaxin C
North
Brunswick, NJ (April XX, 2008) -Advaxis
Inc.,
(OTCBB: ADXS, http://www.advaxis.com.),
a
developmental biotechnology company, garnered national media attention after
having presented landmark results from it’s first-in-man clinical trial of its
flagship drug candidate, Lovaxin C - a live
Listeria
monocytogenes-based
cancer vaccine - at the annual meeting of the American Association for Cancer
Research (“AACR”), held earlier this week in San Diego, CA.
Amanda
Gardner, a health journalist with U.S.
News & World Report, reported
that Listeria, a common bacterium found in leafy vegetables and dairy products,
might be the next weapon in the fight against cervical cancer, a major cause
of
death among women worldwide. The article, titled “Experimental Cancer Vaccines
Show Promise,” described how a new trial illustrated the safety and benefits of
Lovaxin C in fifteen women with advanced cervical cancer. Ms. Gardner’s article
also ran in several major online outlets including Forbes,
Atlanta
Journal Constitution,
HealthCentral.com,
EmpowerHer.com,
and
Austin
American-Statesman.
“Most
of
us eat [Listeria] routinely but don’t know it, because it generates a strong
immune reaction,” the article quotes study lead author John Rothman, vice
president of clinical development at Advaxis Inc. “It can cause disease, but it
can be administered safely, because the lowest doses of any number of
antibiotics will clear it and will do so without impeding the immune
response.”
Among
other results, Rothman reported that Lovaxin C was safely administered in an
end-stage cervical cancer population, that 4 out of 13 evaluable patients
experienced a reduction of their tumors, and that 6 of 15 treated patients
were
alive with a median survival of 454 days on March 3, 2008. The historical
average survival time for diagnosed stage IVB cervical cancer patients is 180
days or less.
1
About
The
American Association For Cancer Research
The
AACR
is the oldest and largest scientific organization in the world focused on every
aspect of high-quality, innovative cancer research. Its reputation for
scientific breadth and excellence attracts the premier researchers in the field.
The programs and services of the AACR foster the exchange of knowledge and
new
ideas among scientists dedicated to cancer research, provide training
opportunities for the next generation of cancer researchers, and increase public
understanding of cancer.
The
AACR:
| · |
Publishes
six peer-reviewed scientific journals: Cancer Research; Clinical Cancer
Research; Molecular Cancer Therapeutics; Molecular Cancer Research;
Cancer
Epidemiology, Biomarkers & Prevention; and Cancer Prevention
Research.
|
| · |
Publishes
CR, a magazine for cancer survivors, patient advocates, their families,
physicians and scientists. It provides a forum for sharing essential,
evidence-based information and perspectives on progress in cancer
research, survivorship, and advocacy.
|
| · |
Convenes
topical scientific conferences and an annual meeting that draws more
than
17,000 participants from the cancer research
community.
|
| · |
Offers
workshops, fellowships and grants for early-career investigators and
investigators-in-training.
|
| · |
Collaborates
with cancer survivors, raises public awareness of the progress in and
cause for hope in cancer research and advocates for strong federal
research funding.
|
For
further information, please visit www.aacr.org.
2
About
Advaxis, Inc.
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 therapeutic cancer vaccines
that enhance the immune system’s cancer-fighting abilities through its
proprietary Lm
based
system, which utilizes multiple simultaneous immunological mechanisms to fight
cancer safely.
Advaxis’
lead Lm
vaccine
candidate, Lovaxin C, targets HPV-associated cervical/head and neck cancers.
Current Lm
vaccines
in development target prostate, breast, ovarian and lung cancers. Recently,
Advaxis completed a Phase I/II clinical trial. A Phase II clinical trial is
planned for patients with cervical intraepithelial neoplasia (CIN). The company
intends to start this study in CIN I/II patients in the summer of 2008.. The
Lm
platform
will also have applications in the fields of infectious disease and autoimmune
disorders.
For
further information on the Company, please visit: http://www.advaxis.com.
About
Lovaxin C Vaccine
Advaxis’
Listeria technology platform uses modified Listeria monocytogenes to deliver
a
tumor-specific antigen fusion protein. Lm,
combined with Advaxis’ proprietary fusion protein, has the ability to generate a
robust immune response and produce an unusually strong and effective multi-level
therapeutic immune response to existing cancers and other diseases.
3
Advaxis’
Lm-based
technology is mostly based on Dr. Yvonne Paterson’s decade worth of work in her
laboratory at the University of Pennsylvania. The Company’s proprietary antigen
fusion protein technology, also suppresses regulatory T cells that inhibit
many
vaccines in the generation of activated tumor-killing cells.
Lovaxin
C
was designed to treat women who have already developed cervical cancer as a
result of contracting a human papilloma virus (“HPV”) infection, which is the
most prevalent sexually transmitted disease in the US. Current prophylactic
products on the market are ineffective in treating HPV-infected
women.
For
further information on Lovaxin C, please visit: http://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.
4
Contacts:
Investor
Relations
The
Investor Relations Group
212-825-3210
Conrad
F.
Mir
conrad@investorrelationsgroup.com
Christine
Berni
christine@investorrelationsgroup.com
Public
& Media Relations
Janet
Vasquez
janet@investorrelationsgroup.com
Hayden
Lynch
hayden@investorrelationsgroup.com
#
# #
# #
5