AGENNIX'S TLF GETS FAST TRACK FOR LUNG CANCER, FOOT ULCERS

Agennix announced that the FDA has granted fast-track designation to the company's Talactoferrin Alfa (TLF) clinical development programs for first-line non-small-cell lung cancer and diabetic foot ulcers. Fast-track status is 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 the designation based on positive Phase II results from a randomized, placebo-controlled trial of oral TLF solution in NSCLC and with topical TLF gel in diabetic foot ulcers.

"We are pleased that the FDA has recognized our lead product, Talactoferrin Alfa, as a potential therapy for patients with these two serious conditions that currently have limited treatment options," said Dr. Frank Young, Chairman of Agennix, and former Commissioner of the FDA. "This Fast Track designation is an important classification as we advance this product into late-stage development."

Talactoferrin Alfa is a unique recombinant form of human lactoferrin, an immunomodulatory protein. Talactoferrin acts by binding to specific receptors found on target cells and inducing the production of key immunomodulatory cytokines and chemokines. Orally administered talactoferrin binds to enterocytes lining the upper gastrointestinal tract, initiating an immunostimulatory cascade in the gut associated lymphoid tissue. This results in the activation of both innate and adaptive immunity including recruitment and activation of dendritic cells, NK-T cells and CD8+ lymphocytes. This is followed by systemic immunostimulation, the activation of tumor-draining lymph nodes, and infiltration of distant tumors by immune cells, which results in killing of the cancer cells. Topically administered TLF binds to keratinocytes and fibroblasts and increases the local production of cytokines and chemokines critical to wound healing.