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): September 15, 2008
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)) |
TABLE OF CONTENTS
Item 8.01 Other Events.
On September 15, 2008, Genta Incorporated, (the Company), announced that the independent Data
Monitoring Board (DMB) for AGENDA, a Phase 3 trial of the Company’s lead oncology product
Genasense® (oblimersen sodium) Injection, has completed its review. During its review, the DMB
evaluated safety data from the study and conducted an analysis for futility. With more than half
of the initially planned number of patients now enrolled, the Board recommended that the trial
continue to completion of full enrollment.
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 identified by a biomarker who have not previously
received chemotherapy. The co-primary endpoints of AGENDA are progression-free survival and
overall survival. A total of 300 patients are expected to enroll in AGENDA.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| |
|
|
| Exhibit |
|
|
| Number |
|
Description |
99.1
|
|
Press Release of the Company dated September 15, 2008 |