FORM 8-K

 

 

 

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): April 30, 2014

 

 

ADVAXIS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   00028489   02-0563870
(State or other jurisdiction
of incorporation)		   (Commission
File Number)		   (IRS Employer
Identification No.)

 

305 College Road East
Princeton, New Jersey		   08540
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (609) 452-9813

 

 

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.

 

Advaxis, Inc. learned today that it has been granted orphan drug designation from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead immunotherapy drug candidate, for the treatment of Stage II-IV invasive cervical cancer.

 

Orphan drug designation is granted to drug therapies intended to treat rare diseases or conditions, classified as diseases or conditions affecting fewer than 200,000 people in the United States. Orphan drug designation entitles the sponsor to clinical protocol assistance with the FDA, as well as federal grants, tax credits, and potentially a seven year market exclusivity period.

 

 
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

ADVAXIS, INC.
     
  By: /s/ Daniel J. O’Connor
  Name: Daniel J. O’Connor
  Title: Chief Executive Officer

 

Date: April 30, 2014