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
|
|
(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
|
|
212
Carnegie
Center #206, Princeton, NJ
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08546
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|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant’s
telephone number, including area code (201)
750-2347
|
|
|
(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
February 21, 2006, the Registrant issued a press release announcing that
regulators have allowed the company to initiate Phase I/II clinical testing
with
its lead compound, Listeria-based cancer vaccine, Lovaxin C. Lovaxin C, which
specifically targets cervical cancer in women, will be tested for the first
time
in humans in this study.
The
Advaxis vaccine Lovaxin C is a therapeutic designed to treat women who have
developed cervical cancer as a result of an HPV infection.
Advaxis
expects to begin dosing at multiple center sites by the end of February. The
study will be conducted at Hadassah Hospital in Jerusalem, The Institute of
Oncology and Radiology in Belgrade, which treats several hundred cervical cancer
patients every year, and at two facilities in Mexico. The first regulatory
approval has been received for Belgrade, with approvals for Israel and Mexico
in
review and anticipated shortly. Advaxis expects to announce the data from these
trials in the second half of 2006.
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 February 21, 2006
|
2
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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| Dated: February 24, 2005 | By: | /s/ Roni Appel |
|
Name: Roni Appel |
||
|
Title:
President and Chief
Executive
Officer
|
||
3
Advaxis’
Listeria Cancer Vaccine Receives
Regulatory
Approval for Phase I/II testing
in
cervical cancer
North
Brunswick, NJ,
February
21, 2006, Advaxis, Inc. (OTCBB: ADXS) announced that regulators have allowed
the
company to initiate Phase I/II clinical testing with its lead compound,
Listeria-based cancer vaccine, Lovaxin C. Lovaxin C, which specifically targets
cervical cancer in women, will be tested for the first time in humans in this
study.
Roni
Appel, President and CEO of Advaxis said: “This day marks a pivotal day for
Advaxis as our first cancer immunotherapeutic enters the clinic.”
Pre-clinical
data for Lovaxin C demonstrates an extremely robust immune response to tumors
upon administration of the drug and eradication of tumors in more than half
of
the animals tested. Unlike other products in late clinical trials, which are
preventative vaccines against the HPV virus (the virus which causes cervical
cancer), but cannot benefit woman already infected with the virus. The Advaxis
vaccine Lovaxin C is a therapeutic designed to treat women who have developed
cervical cancer who as a result of an HPV infection. Advaxis is targeting this
significant unmet medical need with the Lovaxin C vaccine.
“It
is
important to all women that we have finally been given authorization to test
a
cancer vaccine in humans that has been so potent in animal models,” said Mr.
Appel. "This Phase I/II trial is the first step in a comprehensive plan that
will build on the strong pre-clinical results we have seen in more than a decade
of development work. This is the first time a proprietary, modified, disease
specific Listeria will be tested in human patients. We expect that Lovaxin
C
will be the first in a long line of products brought to the
clinic.”
Advaxis
expects to begin dosing at multiple center sites by the end of February. The
study will be conducted at Hadassah Hospital in Jerusalem, The Institute of
Oncology and Radiology in Belgrade, which treats several hundred cervical cancer
patients every year, and at two facilities in Mexico. The first regulatory
approval has been received for Belgrade, with approvals for Israel and Mexico
in
review and anticipated shortly. Advaxis expects to announce the data from these
trials in the second half of 2006. The introduction of Lovaxin C into the clinic
paves the way for Advaxis’ other pipeline products, including those for breast,
ovarian, and prostate cancers, to enter the clinic.
About
Advaxis
Based
in
North Brunswick, New Jersey. Advaxis is developing proprietary Listeria cancer
vaccines based on technology developed by Dr. Yvonne Paterson, professor of
microbiology at the University of Pennsylvania, and chair person of Advaxis'
Scientific Advisory Board. Advaxis is developing therapeutic cancer vaccines
that enhance the immune system's cancer-fighting abilities through its
proprietary Listeria monocytogenes based system, which utilizes 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 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. 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.
Company
Contact
Roni
Appel, 201-750-2347
Investor
Relations Group
Investors:
Erik Lux/Adam Holdsworth, 212-825-3210
Or
Media:
Janet Vasquez, 212-825-3210