Talactoferrin: Phase III data

The double-blind, international Phase III FORTIS-M trial in 742 stage IIIb/IV NSCLC patients who have failed >=2 prior therapies showed that twice-daily 1.5 g oral talactoferrin plus best supportive care (BSC) missed the primary endpoint of median OS vs. placebo plus BSC (7.5 vs. 7.7 months, p=0.66). Agennix said the nature and incidence of adverse events between treatment arms were similar and consistent with previous trials. Based on the data, Agennix will also discontinue the Phase III FORTIS-C trial of talactoferrin as first-line treatment for NSCLC. The company plans to report final data from FORTIS-C, which has enrolled about 100 patients, "within the next few weeks."

As a result, Agennix plans to restructure and reduce headcount to save cash, but said it has not finalized details. The company is evaluating its pipeline, as well as strategic options for the company, including potentially winding down operations. Agennix's remaining pipeline includes a topical formulation of talactoferrin that has completed a Phase IIa trial for diabetic foot ulcers and RGB-286638, a broad spectrum cell cycle kinase inhibitor that has completed a Phase I trial for solid tumors. At June 30, the company had €22.7 million ($28.4 million) in cash and a 6-month net cash burn of €21.5 million ($26.9 million). ...