Agennix Receives Special Protocol Assessment Approval from FDA for the Pivotal Trial of Talactoferrin Alfa in First-Line Non-Small Cell L...(wed and approved the trial protocolstati...)

Date:1/17/2008

wed and approved the trial protocol, statistical analysis plan, independent radiological review charter, data safety monitoring board charter, case report forms and site reference manual. Before approving the SPA, the FDA also evaluated product characterization data for batch-to-batch consistency for Phase 3 and commercial talactoferrin production.

About Talactoferrin Alfa

Talactoferrin, a novel dendritic cell activator (DCA), is a unique recombinant form of human lactoferrin, an important immunomodulatory protein.

In 1988, Dr. Bert O'Malley, chair of molecular and cellular biology at Baylor College of Medicine, Houston, Texas, discovered a way to produce this protein in the laboratory, thus paving the way for testing its potential to help fight serious diseases that cause enormous suffering worldwide. "Baylor views this as exciting news, not only for the important research being done at this medical school but also for the historic battle being conducted to find effective treatments for the most lethal forms of cancer," said Dr. Peter Traber, President of Baylor College of Medicine. "It is our sincere hope that the Phase 3 trials will be successful and this drug can be eventually used globally."

Lactoferrin, found in the highest concentration in milk, is expressed throughout the body in immune cells and on all body surfaces exposed to the external environment. Lactoferrin plays an important role in helping to establish the immune system, including the Gut Associated Lymphoid Tissue (GALT), in infants. Talactoferrin is produced in Aspergillus niger, a filamentous fungus, and is structurally identical to native human lactoferrin in all material respects, differing only in its glycosylation.

Talactoferrin is an orally administered protein that mediates its activity through the gut and the GALT -- the largest lymphoid organ in the body. It acts through a novel mechanism of dendritic cell recruitment and activation. Following oral admi
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SOURCE Agennix Incorporated Copyright©2008 PR Newswire. All rights reserved

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