genta_8k-110110.htm


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):  November 1, 2010
 
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 November 1, 2010, Genta Incorporated, (the Company), announced that the Company has received Scientific Advice from the European Medicines Agency (EMA) on the Company’s clinical development plan for tesetaxel in patients with advanced gastric cancer, which includes a pivotal, randomized, controlled, Phase 3 trial.  The EMA's written advice is supportive of Genta’s proposed Phase 3 trial in patients with advanced gastric cancer whose disease has progressed on 1st-line chemotherapy.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
Number
 
Description
 
99.1
 
Press Release of the Company dated November 1, 2010

 
 

 

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:
November 1, 2010
 
By:
/s/ GARY SIEGEL
       
Name:
Gary Siegel
       
Title:
Vice President, Finance