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): February 11, 2009
GENTA
INCORPORATED
(Exact Name of Registrant
as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
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0-19635
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33-0326866 |
(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 |
(Address of Principal Executive Offices)
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(Zip Code)
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(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a -12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR 240.14d -2(b)) |
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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 February 11, 2009, Genta Incorporated, (the Company), announced that it has submitted a proposal
to the Food and Drug Administration for a randomized clinical trial of tesetaxel, an oral taxane
chemotherapy compound, for Special Protocol Assessment (SPA). A SPA is intended to secure
agreement on the design, size, and endpoints of clinical trials that are intended to form the
primary basis of an efficacy claim in a New Drug Application (NDA). Genta also expects to seek
Scientific Advice from the European Medicines Agency (EMEA) for this study to support a Marketing
Authorization Application (MAA). The Company believes tesetaxel is the leading oral taxane
currently in clinical development.
The proposed protocol will examine the safety and efficacy of tesetaxel in patients with advanced
gastric cancer whose disease has progressed after receiving first-line chemotherapy. Further
details of the study will be announced after final agreement is secured with both regulatory
agencies. FDA has previously granted Orphan Drug designation to tesetaxel for treatment of
patients with advanced gastric cancer
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit
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Description |
99.1
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Press Release of the Company dated February 11, 2009 |