Agennix has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to the company's Talactoferrin Alfa (talactoferrin or TLF) clinical development programmes, 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 randomised, 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."

Oral talactoferrin was recently evaluated in first-line NSCLC, in a 110-patient, randomised, double blind, placebo-controlled, multi-centre phase II clinical trial. Results were presented at the American Society of Clinical Oncology (ASCO) 2006 Annual Meeting. Patients with advanced NSCLC (stage IIIb or IV) received standard first-line chemotherapy, carboplatin/paclitaxel, plus either oral TLF or placebo. The trial met its primary endpoint (best overall confirmed response by CT scan using RECIST criteria), with a substantial improvement in response rate. Substantial improvements in the TLF arm were also observed for secondary endpoints, including progression-free survival (PFS) and overall survival.

TLF appeared to be safe and extremely well tolerated without a single drug-related Serious Adverse Event. TLF-treated patients had fewer total Adverse Events (AEs) and fewer significant (Grade 3/4) AEs than patients receiving chemotherapy alone. The efficacy and safety results generated by TLF in this trial compare favourably to randomised results generated by other drugs in first-line NSCLC.

"Based on the phase II data, I believe that this drug can provide tremendous benefit to patients," said Dr Wan Kid Hong, head of the division of cancer medicine at MD Anderson Cancer Centre and member of Age nix's Scientific Advisory Board. "Assuming similar results in phase III, this should be made broadly available to patients as quickly as possible."

The company will seek a special protocol assessment from the FDA for a large pivotal phase III trial in NSCLC, and expects to initiate this trial in the first half of 2007.

Agennix also completed a randomised, 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 per cent 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 Centre, associate Prof. 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."