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) October 14, 2005
|
Advaxis,
Inc.
|
|
(Exact
name of registrant as specified in its
charter)
|
|
Colorado
|
00028489
|
84
- 1521955
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(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
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(IRS
Employer Identification No.)
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212
Carnegie
Center #206, Princeton, NJ
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08546
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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 (609)
497-7555
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|
|
(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
October 10, 2005, the Registrant issued a press release clarifying the fact
that
its product candidate Lovaxin C, upon successful completion of regulatory
compliance and clinical trials, is expected to be available to treat existing
cervical cancer which has occurred or may occur in the large population of
women
already infected with, or exposed to, the Human Papilloma Virus (the viral
cause
of cervical cancer, “HPV”). Lovaxin C is distinguished from the Merck & Co.
(NYSE: MRK) Pharmaceutical product Gardisil,
which
is
a vaccine that recently successfully completed Phase III trails, and is intended
to prevent the occurrence of cervical cancer in women if administered before
they are exposed to certain types of HPV, but cannot help in the treatment
of
women already infected, some of whom are likely to develop cervical cancer.
See
Registrant’s press release attached hereto as Exhibit 99.1.
Item
9.01. Financial
Statements and Exhibits
a) Not
applicable.
b) Not
applicable.
c) Exhibits
| 99.1. |
Press
Release, dated October 10, 2005
|
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.
| ADVAXIS, INC. | ||
| |
|
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| Date: October 14, 2005 | By: | /s/ J. Todd Derbin |
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Name: J. Todd Derbin |
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| Title: President and Chief Executive Officer | ||
EXHIBIT
99.1
Advaxis’
vaccine candidate to treat existing cervical cancer
Princeton,
NJ, Monday October 10, 7:00 AM ET.
Advaxis
(OTCBB: ADXS), today issued the following clarifications regarding the role
that
its product candidate Lovaxin C may eventually play in the cervical cancer
market and distinguished that role from the role of the Merck & Co. (NYSE:
MRK) Pharmaceutical product Gardisil which has been the subject of a recent
announcement of successful Phase III trials. According to Advaxis’ Chief
Executive Officer J. Todd Derbin,” We felt the need to clarify the different
purposes of the two drugs because a number of our shareholders expressed
concern
that the apparent success of the Merck drug diminished the potential role
of our
therapeutic cervical cancer vaccine Lovaxin C”
J
Todd
Derbin added: “Advaxis believes that Merck’s groundbreaking work in cancer
prevention has shed light on cervical cancer as the number one cancer killer
of
women world wide between the ages of 25 and 50, and the effectiveness of
using
vaccines in this area of therapeutics. The potential ability to vaccinate
women
with Gardisil and confer protection against HPV induced cervical cancer is
a
significant contribution to medicine and represents the highest achievement
that
those of us in the drug development industry strive for; extending life and
improving it’s quality. While Gardisil is intended to prevent the occurrence of
cervical cancer in women if administered before they are exposed to certain
types of Human Papilloma Virus (the viral cause of cervical cancer) Lovaxin
C,
the drug candidate which Advaxis is about to test in a Phase I/II clinical
study, is a therapeutic vaccine with the intended potential to cure women
who
have already been exposed to HPV and who have cervical cancer. The first
Lovaxin
C clinical trial in cervical cancer will start later this year”
“Gardisil
offers tremendous promise in preventing cervical cancer in women not yet
exposed
to HPV, but it cannot help in the treatment of women already infected - some
of
whom will surely develop cervical cancer”, said Dr. John Rothman VP of Advaxis.
“It can take 10-25 years for cervical cancer to develop in infected women,
so
the untreated population at risk today gives rise to the patient pool over
the
next few decades. Moreover, the risk will continue to exist until the vaccinated
population is sufficiently large to reduce transmission, which will likely
take
additional decades to occur. Until such time as vaccination becomes very
widespread there will be a cervical cancer population that requires therapeutic
intervention.”
Dr.
John
Rothman added: “Merck has now shown that it is possible to use immunotherapy to
prevent cervical cancer. Advaxis hopes to be able to confirm, if Lovaxin
C will
successfully pass the regulatory hurdles and clinical trials, that it is
not
only possible to prevent cervical cancer with vaccine therapy in women not
yet
infected by the HPV virus with preventative cervical cancer vaccines, but
it is
also possible to use a therapeutic vaccine such as Lovaxin C to cure existing
cancer which has occurred or may occur in the large population already infected
by it.”
About
Advaxis:
Advaxis
is based in Princeton, New Jersey. Advaxis is developing proprietary Listeria
cancer vaccines based on the vaccine technology developed by Dr. Yvonne Paterson
in the Department of Microbiology at the University of Pennsylvania. Advaxis’ is
developing therapeutic cancer vaccines that enhance the immune system’s
cancer-fighting abilities. Advaxis, through its proprietary Listeria monocytogenes
based
system, is utilizing 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 based on the use of attenuated bacteria Listeria monocytogenes,
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 in late 2005. 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.
____________
Contact:
Advaxis,
Inc.
J.
Todd
Derbin, 609-895-7150
derbin@advaxis.com