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): October 29,
2009
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GENTA
INCORPORATED
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(Exact
Name of Registrant
as
Specified in Its Charter)
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Delaware
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(State
or Other Jurisdiction of Incorporation)
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0-19635
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33-0326866
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(Commission
File Number)
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(IRS
Employer Identification No.)
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200
Connell Drive
Berkeley
Heights, NJ
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07922
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(Address
of Principal Executive Offices)
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(Zip
Code)
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(908)
286-9800
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(Registrant’s
Telephone Number, Including Area Code)
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(Former
Name or Former Address, if Changed Since Last
Report)
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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
October 29, 2009, Genta Incorporated, (the Company), announced that top-line
results from AGENDA, the Company’s Phase 3 trial of Genasense®
(oblimersen sodium) Injection in patients with advanced
melanoma. AGENDA is a randomized, double-blind, placebo-controlled
trial of dacarbazine administered with or without Genasense® in
patients who have not previously received chemotherapy. As defined in
a prior randomized trial, AGENDA uses a biomarker to define patients who might
maximally benefit from treatment.
AGENDA
did not show a statistically significant benefit for its co-primary endpoint of
progression-free survival. Secondary endpoints of overall response
rate and disease control rate (which includes complete and partial responses,
plus stable disease > 3 months
duration) also did not show a statistically significant
benefit. According to the prespecified analysis plan, the statistical
significance of durable response – a secondary endpoint that measures the
proportion of patients who achieved a complete or partial response that lasts
> 6 months –
is too early to evaluate. The observed differences in
progression-free survival, overall response, disease control and durable
response all numerically favored the group that received Genasense®.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
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99.1
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Press
Release of the Company dated October 29,
2009
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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.
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GENTA
INCORPORATED
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Date:
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October
29, 2009
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By:
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/s/
GARY SIEGEL
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Name:
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Gary
Siegel
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Title:
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Vice
President, Finance
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EXHIBIT
INDEX
Exhibit
Number
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Description
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Sequentially
Numbered
Page
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99.1
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Press
Release of the Company dated October 29, 2009
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5
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