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GNTA.OB > SEC Filings for GNTA.OB > Form 8-K on 8-Apr-2009All Recent SEC Filings

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Form 8-K for GENTA INC DE/


8-Apr-2009

Other Events, Financial Statements and Exhibits


Item 8.01 Other Events.

On April 7, 2009, Genta Incorporated, (the Company), announced that the Company had completed patient enrollment into AGENDA, a Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma. Final accrual totaled 315 subjects.

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 was designed to confirm certain safety and efficacy results obtained in a prior randomized trial of Genasense combined with dacarbazine (DTIC) in patients who have not previously received chemotherapy (GM301). AGENDA employs a biomarker to define those patients who derived maximum clinical benefit during the preceding study. These patients are characterized by low-normal levels of LDH (lactate dehydrogenase), a tumor-derived enzyme that is readily detected in blood.



Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

  Exhibit
  Number    Description
   99.1     Press Release of the Company dated April 7, 2009


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