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news.Agennix has initiated the next stage of the Fortis-M trial, with the first patient being dosed in Europe. Fortis-M is a phase 3 registration trial evaluating oral Talactoferrin, versus placebo, in advanced non-small cell lung cancer (NSCLC), in patients whose disease has progressed following two or more prior therapies.
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Fortis-M is a global, multicenter, randomised, double-blind, placebo-controlled phase 3 trial. It evaluates oral Talactoferrin plus best supportive care compared to placebo, plus best supportive care in patients with stage IIIB/IV non-small cell lung cancer, whose disease has progressed after two or more prior treatment regimens.
The trial is expected to enroll approximately 720 patients. The company said that it is enrolling patients in the US sites and is now being expanded into Europe and the rest of the world.
Rajesh Malik, chief medical officer at Agennix, said: “Expansion of the Fortis-M trial to sites outside the US is an important step in the continued development of talactoferrin for non-small cell lung cancer. Patient recruitment is on track and, assuming the trial proceeds as planned, completion of enrollment is anticipated to occur sometime in the first half of 2011, with top line data available by the end of 2011.”