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) August 8, 2005
|
Advaxis,
Inc.
|
|
(Exact
name of registrant as specified in its
charter)
|
|
Delaware
|
00028489
|
84
- 1521955
|
|
(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
|
|
212
Carnegie
Center #206, Princeton, NJ
|
08546
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant’s
telephone number, including area code (609)
497-7555
|
|
|
(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
August
8, 2005, the Registrant announced that its GMP clinical materials had passed
quality control release and is available for use in Advaxis’ Phase I/II clinical
trial of Lovaxin C in advance cervical cancer patients. 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 August 8, 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.
Dated: August
8,
2005
| ADVAXIS, INC. | ||
| |
|
|
| By: | /s/ J. Todd Derbin | |
|
Name:
J.
Todd Derbin
Title:
President
and Chief
Executive
Officer
|
||
EXHIBIT
99.1
|
Press
Release
|
Source:
Advaxis, Inc.
|
Advaxis,
Inc. Release of Clinical GMP Materials
for Phase I/II in Cervical cancer
Monday
Aug 8, 2005 11:00 AM ET
PRINCETON,
NJ--(BUSINESS WIRE)—August 8, 2005--Advaxis, Inc. (OTCBB: ADXS
-
News),
("Company" or "Advaxis"), today announced that its GMP clinical materials has
passed quality control release and is available for use in Advaxis’ Phase I/II
clinical trial of Lovaxin C in advance cervical cancer patients. This first
in
man study will be the first time a live Listeria vaccine is used as a
therapeutic agent in cancer. 20 patients receiving one of 4 different doses
will
be assessed for safety and tolerance. Efficacy of Lovaxin C will be assessed
across various parameters including tumor measurements, RECIST scores, and
immunologic responsiveness.
The
manufacturing process, which is a fermentation of Advaxis’ live Listeria
construct, generated sufficient material to provide enough doses to support
the
Lovaxin C clinical program in Cervical and Head & Neck cancers through Phase
I and Phase II, and possibly into Phase III. The manufacturing process
development resulted in additional intellectual property which provides Advaxis
with protection of its proprietary manufacturing processes that do not use
any
animal derived components. The methods and materials used provide a well defined
regulatory pathway and method of producing Lovaxin C which will greatly
facilitate regulatory review.
J.
Todd
Derbin, President and CEO said: “We are very pleased with the completion and
availability of our GMP material. The successful completion of this work has
resulted in a projected low cost per dose on a scaled up basis, which compares
very favorably with the cost per dose of competing live vaccine
products”.
About
Advaxis:
Advaxis
is based in Princeton, New Jersey. Advaxis focuses on commercializing the
innovative 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 cancer vaccines. Advaxis is the exclusive
licensee of a patented broadly enabling innate immunity platform technology,
which is based on the usage of the attenuated bacteria Listeria Monocytogenes,
that, when combined with classical antibody and cellular immune mechanisms,
can
elicit more effective anti-tumor responses. Advaxis' lead vaccine candidate,
Lovaxin C, targets cervical and head and neck cancers. Further vaccines in
development target breast, ovarian and lung cancers.
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.
Advaxis,
Inc.
J.
Todd
Derbin, 609-895-7150
derbin@advaxis.com
or
Strategic
Growth International
Investor
Relations:
Jennifer
K. Zimmons, Ph.D.,212-838-1444
jzimmons@sgi-ir.com