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
June
3, 2009
(Date of
Earliest Event Reported)
Advaxis,
Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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00028489
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02-0563870
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(State or other
jurisdiction
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(Commission
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(IRS
Employer
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of
incorporation)
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File
Number)
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Identification
No.)
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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.)
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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):
¨ Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
¨ 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
June 3, 2009, Advaxis, Inc. issued a press release regarding the response from
the Food & Drug Administration’s denial for its request for Orphan Drug
Designation in invasive cervix cancer.
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 June 3, 2009
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:
June 3, 2009
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Advaxis,
Inc.
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||
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By:
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/s/
Thomas A. Moore
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Name:
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Thomas
A. Moore
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Title:
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Chief
Executive Officer
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SCIENCE
NEWS
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Exhibit
99.1
ADVAXIS
RECEIVES FDA RESPONSE TO ORPHAN DRUG FILING
North Brunswick, NJ – June 2, 2009 –
Advaxis, Inc. (OTCBB: ADXS) received the
FDA letter late on June 1 denying the company’s request for Orphan Drug
Designation (ODD) for the use of ADXS11-001 in invasive cervix cancer. The FDA
stated their market definition for invasive cervical cancer prevalence
(including all those who had been cured) is over the 200,000 person cutoff.
Further, the applicability of ADXS11-01 for a precursor condition, cervical
intraepithelial neoplasia (CIN) was considered by the ODD as an early
manifestation of the disease. No prevalence estimate for CIN was provided in our
original application. There was no issue raised about
efficacy.
Advaxis
Chairman and CEO Thomas Moore commented, “When we announced this ODD filing, we
said it was historically a 50% probability of getting approved. With an annual
incidence of only 10,000 patients in the US diagnosed with invasive cervical
cancer and a very poor prognosis if standard therapies fail, which they do for
about half these patients, this appeared to be just what Orphan Drug was
designed to encourage. The FDA Office of Orphan Products Development was very
cooperative with us but we are naturally disappointed.”
"We have
pending study activity in cervical cancer in collaboration with NCI and plan to
conduct at least one additional off-shore study. Our Phase I results showed
great promise. We will likely seek another regulatory route for this indication,
Fast Track designation, for which we can apply in the near term. If approved,
Fast Track provides similar advantages in regulatory acceleration, but provides
no market exclusivity or the possibility of grant support from
FDA."
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 attenuated live Lm vaccines
that deliver engineered tumor antigens, which stimulate multiple simultaneous
immunological mechanisms to fight cancer.
For
further information on the Company, please visit: www.advaxis.com.
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.
For
Further Information:
Conrad
Mir
Director,
Business Development
Advaxis,
Inc.
732.545.1590
(Office)
732.545.1084
(FAX)
conradmir@advaxis.com
www.advaxis.com