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):  April 7, 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 April 7, 2009, Genta Incorporated, (the Company), announced that the Company had completed patient enrollment into AGENDA, a Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma.  Final accrual totaled 315 subjects.

AGENDA is a Phase 3, randomized, double-blind, placebo-controlled trial that is intended to support global registration of Genasense for patients with advanced melanoma.  The study was designed to confirm certain safety and efficacy results obtained in a prior randomized trial of Genasense combined with dacarbazine (DTIC) in patients who have not previously received chemotherapy (GM301).  AGENDA employs a biomarker to define those patients who derived maximum clinical benefit during the preceding study.  These patients are characterized by low-normal levels of LDH (lactate dehydrogenase), a tumor-derived enzyme that is readily detected in blood.


Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 
 
Exhibit
Number
  
Description 
 
 
 
99.1
  
Press Release of the Company dated April 7, 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:
  April 7, 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 April 7, 2009