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news.The FDA has granted fast track designation to Agennix's drug talactoferrin alfa, for the treatment of lung cancer and diabetic foot ulcers.
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Fast track is a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and address unmet medical needs.
Agennix submitted applications to the FDA for Fast Track designation based on positive randomized, placebo-controlled phase II results with oral TLF solution in NSCLC and with topical TLF gel in diabetic foot ulcers.
Oral talactoferrin was recently evaluated in first-line NSCLC in a study that met its primary endpoint.
The company is also seeking a special protocol assessment from the FDA for a large phase III trial in NSCLC, and expects to initiate this trial in the first half of 2007.