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
July
29, 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
July 29, 2008, Advaxis, Inc issued a press release regarding its Investigational
New Drug application for Lovaxin C.
A
copy of the press release is attached as Exhibit 99.1 to this Current Report
and
is incorporated herein by this reference.
| Item 9.01 |
Financial
Statements and Exhibits
|
| 99.1 |
Advaxis,
Inc. press release, dated July 29,
2008
|
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:
July 29, 2008
| Advaxis, Inc. | ||
| |
|
|
| By: |
/s/
Thomas A. Moore
|
|
|
Name: Thomas A. Moore |
||
| Title: Chief Executive Officer | ||
Exhibit
99.1
ADVAXIS
INCORPORATED RECEIVES LIST OF QUESTIONS
FROM
THE U.S. FOOD AND DRUG ADMINISTRATION
Response
to the Company’s IND for Its Lead Drug Candidate,
Lovaxin
C, For the Treatment of Cervical Intraepithelial
Neoplasia
North
Brunswick, NJ - July 29, 2008 - Advaxis
Inc.,
(OTCBB: ADXS),
a
developmental biotechnology company, received
comments from the U. S. Food & Drug Administration (the “FDA”) regarding its
Investigational New Drug (“IND”) application for Lovaxin C, the Company’s lead
drug candidate, which was filed with a proposed Phase II study for the treatment
of Cervical Intraepithelial Neoplasia (“CIN”).
The
FDA’s
first written response letter, received last week, addressed preclinical,
manufacturing, microbiologic, immunologic and clinical questions concerning
Lovaxin C and its therapeutic use in CIN and cervical cancer caused by the
sexually transmitted human papilloma virus (“HPV”). The FDA also requested
additional justification for the first proposed Phase II study in this
indication and the potential risks and benefits of the proposed therapy relative
to the current surgical standard therapy.
”We
will
respond to these requests in short order,” commented Advaxis Chairman & CEO
Thomas Moore. “In the interim, the proposed Phase II study is on clinical hold
as we work closely with the FDA to address their concerns.”
A
recently completed Phase I trial of Lovaxin C addressed advanced, recurrent
cervical cancer with distant metastases among patients who had failed prior
therapy. This trial of 15 patients administered multiple doses of Lovaxin
C to
patients with advanced disease. Advaxis plans to conduct additional work
with
Lovaxin C in cervical cancer treatment in collaboration with the National
Cancer
Institute (the “NCI”) beginning in early 2009.
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.
Advaxis’
lead Listeria
vaccine
candidate, Lovaxin C, targets HPV-associated cancers such as cervical, and
head
and neck. Current Lm vaccines in development target prostate, breast and
ovarian
and other cancers. The Lm platform also has 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. Bioengineered Listeria
that are
attenuated and secrete Advaxis’ proprietary fusion protein, have the ability to
generate a robust immune response, break immune tolerance to cancer and produce
an unusually strong and effective multi-level therapeutic immune response
to
existing cancer and other diseases.
Advaxis’
Listeria-based
technology is based on over a decade’s worth of work by Dr. Yvonne Paterson in
her laboratory at the University of Pennsylvania. The Company’s proprietary
antigen fusion protein technology, stimulates innate immunity, both arms
of the
adaptive cellular immune system, suppresses regulatory T cells that inhibit
many
vaccines in the function of activated tumor-killing cells and has other
anti-tumor effects.
Unlike
prophylactic vaccines, Lovaxin C was designed to treat women who have already
developed cervical cancer because of contracting a human papilloma virus
(“HPV”)
infection, which is the most prevalent sexually transmitted disease in the
US.
Current 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, 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, including regulatory actions. The Company cannot guarantee its
future results, levels of activity, performance or achievements.
Contacts:
The
Investor Relations Group
212-825-3210
Investor
Relations
Conrad
F.
Mir
cmir@investorrelationsgroup.com
Christine
A. Berni
cberni@investorrelationsgroup.com
Public
& Media Relations
Janet
Vasquez
jvasquez@investorrelationsgroup.com
Laura
Colontrelle
lcontrelle@investorrelationsgroup.com
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