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 29, 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 a final progress update on the Company’s Phase 3 trial of Genasense® (oblimersen sodium) Injection, Genta’s lead oncology product, in patients with advanced melanoma.  The trial recently completed accrual, and final data on progression-free survival (PFS) – a co-primary endpoint in this trial -- are anticipated in the Fall of 2009.

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 is designed to confirm certain safety and efficacy results from Genta’s prior randomized trial of Genasense combined with dacarbazine (DTIC) in patients who have not previously received chemotherapy and who are identified by a biomarker (low-normal levels of lactate dehydrogenase [LDH]).   The co-primary endpoints of AGENDA are PFS and overall survival.


Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number
  
Description
  
99.1
  
Press Release of the Company dated April 29, 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 29, 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 29, 2009