Genta, Inc (fka GNTAQ)

[The GidDy uP Kid]

Form 8-K for GENTA INC DE/

11-Feb-2009

Other Events


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.