Date: 2011-06-05
Type of information:
phase: 2
Announcement: results
Company: Agennix (Germany)
Product: talactoferrin
Action mechanism: Talactoferrin is an oral immunotherapy that is being studied for the treatment of cancer and severe sepsis.
Disease: severe sepsis
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: Agennix AG has announced that new data from Phase II trials in non-small cell lung cancer and in severe sepsis demonstrating the activity and tolerability of talactoferrin, an oral immunotherapy with antibacterial properties, were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Talactoferrin appears to improve survival in various prognostic subsets in Phase II trial in 2nd-line+ non-small cell lung cancer Data from the Company’s Phase II trial evaluating talactoferrin plus best supportive care compared to placebo plus best supportive care in 2nd-line+ non-small cell lung cancer (NSCLC) were presented as a poster, “The effect of talactoferrin on overall survival in prognostically important NSCLC subsets in a randomized, placebo-controlled Phase II trial“ (abstract #7569). The effect of talactoferrin on overall survival in this study was seen in a number of prognostically important patient subsets, including squamous and non-squamous histologies (tissue types). As previously disclosed, the trial met its primary endpoint, showing a 65% increase in median overall survival in the talactoferrin arm compared to control (6.1 months for talactoferrin versus 3.7 months for placebo; hazard ratio 0.68, one-tailed p-value <0.05). Overall survival data from a variety of patient subsets were presented in the poster at ASCO: Group Subgroup N Hazard Ratio (90% Confidence Interval) ITT (overall population) 100 0.68 (0.47, 0.98) Histology Non-squamous 79 0.70 (0.45, 1.07) Squamous 21 0.43 (0.16, 1.13) Gender Male 66 0.62 (0.39, 0.99) Female 34 0.97 (0.51, 1.83) Age Group ?65 yr 75 0.70 (0.45, 1.08) >65 25 0.54 (0.25, 1.18) Disease Stage IIIB 25 0.61 (0.30, 1.22) IV 75 0.68 (0.44, 1.06) Line of Therapy 2nd 75 0.71 (0.46,1.10) >3rd 25 0.58 (0.26, 1.28) ECOG PS 0 23 0.54 (0.24, 1.18) 1 77 0.70 (0.46, 1.08) Talactoferrin was shown to be very well tolerated in this study, with fewer adverse events compared to placebo. The most frequently reported severe adverse event was dyspnea (labored breathing), which occurred in 15% of patients in the talactoferrin arm and 26% in the control arm. There were no serious adverse events considered to be related to treatment with talactoferrin. Enrollment has completed in the Company’s ongoing Phase III FORTIS-M trial evaluating talactoferrin plus best supportive care compared to placebo plus best supportive care in NSCLC patients whose disease has progressed following two or more prior treatment regimens. Topline results are expected in the first half of 2012. Talactoferrin reduces mortality in severe sepsis patients with different types of infections Data from a randomized Phase II study that evaluated 190 patients with severe sepsis who received talactoferrin or placebo were presented in a poster discussion session, “Consistent mortality reduction by talactoferrin alfa (TLF) in severe sepsis with different types of infections” (abstract #9024). As previously reported, the study met the primary endpoint of reducing 28-day all-cause mortality. Talactoferrin was shown to have an effect across different sites and types of infection. In the talactoferrin Phase II trial in severe sepsis, the most common sites of infection were the lungs and blood. There was a consistent mortality decrease in the talactoferrin arm by sites of infection with the exception of intra-abdominal infection. A consistent reduction in mortality also occurred in patients with different types of infections, such as those caused by a single organism (e.g., a bacterium or fungus) or multiple organisms. The above analyses were all conducted on a modified intent-to-treat (ITT) as treated basis, meaning that patients were evaluated based on the treatment they actually received (talactoferrin or placebo) during the first week on study. Talactoferrin was very well tolerated in the study with no significant differences between the two treatment arms in frequency or severity of adverse events. There were no serious adverse events considered to be related to treatment with talactoferrin. The Phase II trial was primarily funded by a grant from the U.S. National Institutes of Health.
