Unassociated Document
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):  May 19, 2009
 
GENTA INCORPORATED
(Exact Name of Registrant
as Specified in Its Charter)
 
 
Delaware
  
 
(State or Other Jurisdiction of Incorporation)
  
 
0-19635
  
33-0326866
(Commission File Number)
  
(IRS Employer Identification No.)
 
200 Connell Drive
Berkeley Heights, NJ
  
07922
(Address of Principal Executive Offices)
  
(Zip Code)
 
 
(908) 286-9800
  
(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:

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 May 19, 2009, Genta Incorporated, (the Company), announced that the independent Data Monitoring Board (DMB) for AGENDA, a randomized Phase 3 trial of Genasense® in patients with advanced melanoma, has informed the Company that the study has passed its final futility analysis  for progression-free survival (PFS).  Accordingly, the Board has recommended that the study should continue to completion.

Coincident with this recommendation, Genta has submitted an “intent-to-file” notice via the centralized procedure to the European Medicines Agency (EMEA), along with a request for assignment of rapporteurs.  Such notice is required prior to submission of a Marketing Authorization Application (MAA).

 
Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
Number
  
Description
99.1
  
Press Release of the Company dated May 19, 2009
 
 
 
 
 
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.
 
 
 
GENTA INCORPORATED
  
       
Date  May 19, 2009
By:
/s/ GARY SIEGEL
  
   
Name:  Gary Siegel
  
   
Title:    Vice President, Finance
  
       
 
 
 
 
 
EXHIBIT INDEX
 
Exhibit
Number
Description
Sequentially
Numbered Page
     
99.1
Press Release of the Company dated May 19, 2009