Die Ergebnisse der Genasense Studien sollten ursprünglich im April kommen, aber die Auswertung der Ergebnisse der AGENDA Studie brauchen wohl noch länger. Genasense wurde in einem veränderten Studiendesign getestet, und deshalb glaubt Genta, dass die Ergebnisse diesmal so gut sein werden, dass Genta eine Zulassung noch im Jahr 2011 angehen kann. Das würde in jedem Fall einen Kurssprung bedeuten.
Genasense® Phase 3 trial results: In April 2011, Genta expects to report final data on overall survival (OS) from AGENDA, the Company’s randomized, double-blind, Phase 3 trial of dacarbazine with or without Genasense® (oblimersen sodium) Injection in patients with advanced melanoma. Formal followup on all patients concludes in March 2011, two years from randomization of the last patient. While differences in early endpoints of overall response and progression-free survival favored the group treated with Genasense, those differences did not achieve statistical significance. The Company believes that a statistically significant increase in OS would enable submission of applications for regulatory approval of Genasense in advanced melanoma during 2011
Genasense® Phase 3 trial results: In April 2011, Genta expects to report final data on overall survival (OS) from AGENDA, the Company’s randomized, double-blind, Phase 3 trial of dacarbazine with or without Genasense® (oblimersen sodium) Injection in patients with advanced melanoma. Formal followup on all patients concludes in March 2011, two years from randomization of the last patient. While differences in early endpoints of overall response and progression-free survival favored the group treated with Genasense, those differences did not achieve statistical significance. The Company believes that a statistically significant increase in OS would enable submission of applications for regulatory approval of Genasense in advanced melanoma during 2011