Genta Announces Top-Line Results of AGENDA Phase 3 Trial of Genasense® in Patients with Advanced Melanoma
"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 [greater than or equal to] 3 months duration) also did not show a statistically significant benefit."
" “At this time, we cannot predict whether more mature data will reveal a benefit in either overall survival or durable response,” said Dr. Raymond P. Warrell., Jr., Genta’s Chief Executive Officer. “However, the immediate failure to confirm a significant improvement in progression-free survival will preclude our submission of a regulatory application this year. Management and the Board are currently assessing the impact of these data on the Company’s strategic direction."
"Genta management will host a conference call and live audio webcast to discuss results of the AGENDA trial on Thursday October 29, 2009 at 8:00 AM ET."
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