January 17, 2008 — Agennix Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase 3 trial evaluating its lead molecule, talactoferrin alfa, in combination with chemotherapy as first-line treatment in patients with non-small cell lung cancer (NSCLC) under the Special Protocol Assessment (SPA) process. Separately, Agennix received Scientific Advice from the European Medicines Agency (EMEA) indicating that this single trial will also support a Marketing Authorization Application (MAA) in the European Union. Agennix had previously received Fast Track designation from the FDA for this indication... Agennix' Press Release-Jan 28, 2008
Agennix, Pivotal Trial of Talactoferrin Alfa in First-Line Non-Small Cell Lung Cancer,
January 17, 2008 — Agennix Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase 3 trial evaluating its lead molecule, talactoferrin alfa, in combination with chemotherapy as first-line treatment in patients with non-small cell lung cancer (NSCLC) under the Special Protocol Assessment (SPA) process. Separately, Agennix received Scientific Advice from the European Medicines Agency (EMEA) indicating that this single trial will also support a Marketing Authorization Application (MAA) in the European Union. Agennix had previously received Fast Track designation from the FDA for this indication... Agennix' Press Release-
