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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): June 30, 2011
ADVAXIS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
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00028489
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02-0563870
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(Commission File Number)
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(IRS Employer Identification Number)
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305 College Road East
Princeton, New Jersey 08540
(Address of principal executive offices)
Registrant’s telephone number, including area code: (609) 452-9813
Not applicable
(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:
¨ 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))
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Item 8.01.
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Other Events.
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On June 30, 2011, Advaxis, Inc. (the “Company”) issued a press release announcing that it had been granted a pre-Investigational New Drug meeting with the U.S. Food and Drug Administration on August 10, 2011 to discuss the CMC, pharmacology, toxicology, and clinical plans for Advaxis PSA, its construct to fight prostate cancer. A copy of the press release, which is attached as Exhibit 99.1 to this Current Report, is incorporated herein by reference.
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Item 9.01.
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Financial Statements and Exhibits.
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(d) Exhibits
99.1 Advaxis, Inc. press release, dated June 30, 2011.
SIGNATURES
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.
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Dated: June 30, 2011
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Advaxis, Inc.
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By:
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/s/ Mark J. Rosenblum
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Mark J. Rosenblum
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Chief Financial Officer and Secretary
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EXHIBIT INDEX
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Exhibit No.
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Document Description
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99.1
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Advaxis, Inc. press release, dated June 30, 2011.
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Exhibit 99.1
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CLINICAL UPDATE
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FOR IMMEDIATE RELEASE
ADVAXIS GRANTED PRE-IND MEETING WITH THE FDA
FOR ADVAXIS-PSA PROSTATE IMMUNOTHERAPY
Princeton, NJ – June 30, 2011 – Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has been granted a pre-Investigational New Drug (“IND”) meeting with the U.S. Food and Drug Administration (“FDA”) on August 10, 2011 to discuss the CMC, pharmacology, toxicology, and clinical plans for Advaxis PSA, its construct to fight prostate cancer.
The product is being manufactured by Advaxis' contractor, Vibalogics, in Germany. The Company plans to file the IND application later this year to initiate a Phase I/II safety study in humans.
About Advaxis Incorporated
Advaxis is a biotechnology company developing proprietary, live but attenuated Listeria monocytogenes (Listeria) vaccines that deliver engineered tumor antigens, which stimulate multiple, simultaneous immunological mechanisms to fight cancer. Today, the Company has fifteen (15) distinct, cancer-fighting constructs in various stages of development, directly and through strategic collaborations with such recognized sites of excellence as the City of Hope, the Roswell Park Cancer Institute, the National Cancer Institute, the University of Pittsburgh, Cancer Research – UK, the University of British Columbia and the Department of Homeland Security. Please visit the Company’s portals: advaxis.com | facebook | twitter | LinkedIn
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:
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Conrad F. Mir
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Diana Moore
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Executive Director
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Analyst
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Advaxis Incorporated
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Advaxis Incorporated
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609.452.9813 (Office)
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dmoore@advaxis.com
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mir@advaxis.com
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