Agennix's talactoferrin misses Phase III NSCLC endpoint

Agennix AG (Xetra:AGX) said twice-daily oral talactoferrin plus best supportive care missed the primary endpoint of median overall survival (OS) vs. placebo plus best supportive care in the Phase III FORTIS-M trial to treat refractory non-small cell lung cancer (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. The double-blind, international trial enrolled 742 stage IIIb/IV patients who have failed at least two prior therapies. The company said it is taking immediate steps to conserve cash while it evaluates its business options. A second Phase III trial -- FORTIS-C -- is evaluating talactoferrin as first-line treatment of NSCLC. At June 30, the company had EUR 22.7 million ($28.4 million) in cash and a six-month net cash burn of EUR 21.5 million ($26.9 million).

In February, Agennix stopped the Phase II/III OASIS trial in patients with severe sepsis after talactoferrin plus standard of care led to an increased rate of 28-day all-cause mortality compared to placebo plus standard of care. Talactoferrin is a recombinant human lactoferrin (rhLF) (see BioCentury, Feb. 2). ...