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Agennix Receives Special Protocol Assessment Approval from FDA for the Pivotal Trial of Talactoferrin Alfa in First-Line Non-Small Cell Lung Cancer
Date:1/17/2008

Trial will also Support a Marketing Authorization Application in the

European Union

HOUSTON, Jan. 17 /PRNewswire/ -- Agennix Incorporated announced today 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.

"The Special Protocol Assessment agreement with the FDA is an important step for advancing the investigation of talactoferrin in NSCLC," said Dr. Roman Perez-Soler, Director, Division of Medical Oncology, Albert Einstein College of Medicine, New York City. "The Phase 2 data from the two separate randomized, double-blind, placebo-controlled NSCLC trials are very promising. I look forward to participating in the Phase 3 talactoferrin trials for both NSCLC indications -- first-line in combination with chemotherapy, and talactoferrin monotherapy in patients who have failed two or more previous therapies."

In the randomized, double-blind, placebo-controlled Phase 2 NSCLC trials, talactoferrin (or placebo) was administered either in combination with chemotherapy in chemo-naive patients, or as monotherapy in patients who had failed previous chemotherapy. Both trials met their prospectively defined primary endpoints -- improvement in response rate (first-line combination trial) and improvement in survival (monotherapy trial), with supporting trends on secondary efficacy endpoints. Both trials also showed statistically significant reductions in total adverse
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SOURCE Agennix Incorporated
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