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Press Release: Agennix Receives FDA Fast Track Designation for Talactoferrin Alfa in Non-Small Cell Lung Cancer and Diabetic Foot Ulcers
Thursday October 5, 9:00 am ET
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.
Talactoferrin alfa, a recombinant human lactoferrin promotes healing of diabetic neuropathic ulcers: a phase 1/2 clinical study.
Lyons TE, Miller MS, Serena T, Sheehan P, Lavery L, Kirsner RS, Armstrong DG, Reese A, Yankee EW, Veves A. Am J Surg. 2007 Jan;193(1):49-54. Related Articles
BACKGROUND: Talactoferrin alfa, a recombinant form of human lactoferrin, is a novel immunomodulatory protein with demonstrated ulcer healing properties in animal models.
METHODS: A phase 1/2 clinical study was conducted at 7 clinical sites to determine if talactoferrin can improve wound healing in diabetic patients with foot ulceration. Fifty-five patients with diabetic neuropathic foot ulcers participated in this 2-phase study. In phase 1, groups of 3 patients each received open-label 1%, 2.5%, or 8.5% talactoferrin gel twice daily, in a sequential design, to their ulcer for 30 days. No drug-related adverse events were found at any dose level. Phase 2 was a randomized, placebo-controlled, single-blind study of 2.5% and 8.5% gels, with patients equally divided between the 3 groups. In combination with good wound care, treatment was administered topically twice daily to the ulcers for 12 weeks. The primary endpoint was the incidence of >/=75% healing (relative to baseline size).
RESULTS: The study, which in phase 2 was powered to detect a difference between the placebo and combined talactoferrin arms with P < .1, met the primary objective. The groups receiving the 2.5% (n = 15) and 8.5% (n = 15) gels had twice the incidence of >/=75% reduction in ulcer size compared with the placebo group (n = 16): 47%, 53%, and 25%, respectively. On an intent-to-treat basis, the combination of the 2 active groups when compared with the placebo group showed a strong trend toward statistical significance (P = .09). There were no talactoferrin-related adverse events or laboratory abnormalities.
CONCLUSIONS: Topical talactoferrin appears to be safe and well tolerated and improves healing of diabetic neuropathic ulcers.