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): March 31,
2010
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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 March
31, 2010, Genta Incorporated, (the Company), announced that the Company has
initiated a confirmatory Phase 2b trial of tesetaxel in patients with advanced
gastric cancer. Tesetaxel is the Company’s newest clinical-stage
small molecule. As a late Phase 2 oncology product, tesetaxel is the
leading oral taxane currently in clinical development. The trial is
currently open to enrollment at Northwestern University, Chicago, IL, which will
be joined by M.D. Anderson Cancer Center in Houston, TX and several additional
sites.
The new
trial is designed to confirm the efficacy results observed in a preliminary
Phase 2a study of tesetaxel as 2nd-line
treatment of patients with advanced gastric cancer (see results below) and will
enroll patients who have progressed on a single 1st-line
chemotherapy regimen. Unlike conventional taxanes (paclitaxel
[Taxol®] or
docetaxel [Taxotere®]) that
must be infused intravenously, tesetaxel is a capsule that is taken by
mouth. Endpoints of the new Phase 2b study include response rate,
durable response, disease control, progression-free survival, and
safety. The dose for the new trial was determined from Genta’s
recently completed dose-ranging and pharmacokinetic study, whose results have
been accepted for presentation at the upcoming annual meeting of the American
Society of Clinical Oncology (ASCO) in June 2010.
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 March 31,
2010
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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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March
31, 2010
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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 March 31, 2010
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5
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