HOUSTON, Oct. 5 (UPI) -- Agennix said Thursday the U.S. Food and Drug Administration granted fast-track status to talactoferrin alfa for cancer/diabetic foot ulcers.
Agennix's applications for fast-track status were based on phase 2 trials with oral talactoferrin alfa, or TLF, in non-small cell lung cancer and a phase 2 trial with topical TLF gel in diabetic foot ulcers. The company has previously announced the positive results of these trials.
"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 Frank Young, Agennix's chairman and former FDA commissioner.
"This Fast Track designation is an important classification as we advance this product into late-stage development," Young added.
Agennix said it plans to seek FDA approval for a pivotal phase 3 trial in non-small cell lung cancer and anticipates starting this study next year.
