HOUSTON, Oct. 5 /PRNewswire/ -- Agennix today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's Talactoferrin Alfa (talactoferrin or TLF) clinical development programs for first-line non-small cell lung cancer (NSCLC) and diabetic foot ulcers. 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.
"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."
Diabetic Foot Ulcers:
Agennix also completed a randomized, placebo-controlled, NIH-sponsored, Phase II clinical trial evaluating topical TLF in patients with diabetic foot ulcers. The results were presented at the 2006 Symposium on Advanced Wound Care and Medical Research Forum on Wound Repair, and have been accepted for publication in the American Journal of Surgery. The trial met its prospectively defined primary endpoint of improvement in the incidence of 75 percent or greater healing at the end of 12-week dosing relative to placebo. Talactoferrin gel enhanced wound healing compared to a placebo gel with a relative improvement that was superior to published results with the currently approved therapy.
"The clinical data with talactoferrin is very promising," commented Dr. Aristidis Veves, Research Director of the Joslin-Beth Israel Deaconess Foot Center, Associate Professor of Surgery at Harvard Medical School, and a principal investigator in the Phase II trial. "There is a tremendous and growing need for new drug therapies for diabetic foot ulcers, and talactoferrin appears to have the potential to be broadly used."
About Talactoferrin Alfa:
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.
Click to expand...