Date: 2012-11-30
Type of information:
phase: 3
Announcement: update on results
Company: Agennix (Germany)
Product: talactoferrin alfa
Action mechanism: Talactoferrin is an oral biologic therapy with immunomodulatory and antibacterial properties, which is being studied for the treatment of cancer and severe sepsis..
Disease: severe sepsis
non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology, Infectious diseases
Country:
Trial details:
Latest
news: Agennix has announced results from several clinical studies evaluating talactoferrin alfa (talactoferrin). Agennix has now performed extensive analyses of the talactoferrin program to determine if there is a potential
FORTIS-C Phase III trial with talactoferrin in first-line non-small cell lung cancer closed early and unblinded. As previously announced, following the negative results of the FORTIS-M Phase III trial evaluating talactoferrin in non-small cell lung cancer (NSCLC) patients whose disease had progressed following two or more prior treatment regimens, Agennix made the decision to stop enrollment and analyze the results from the FORTIS-C Phase III trial. This trial evaluated talactoferrin in combination with a standard chemotherapy regimen, carboplatin plus paclitaxel, compared to placebo plus carboplatin and paclitaxel in first-line NSCLC patients with advanced or metastatic disease (patients who have not yet been treated for their disease). At the time the FORTIS-C trial was stopped, 94 of the planned 1,100 patients had been enrolled and received study drug; all patients were enrolled at five U.S. sites. The study had co-primary endpoints of progression-free survival (PFS) and overall survival (OS). Investigator-reported median PFS in the talactoferrin arm was 5.8 months compared to 5.6 months for placebo(hazard ratio 0.97, p-value 0.89). Median OS in the talactoferrin arm was 11.4 months compared to 12.7 months for placebo (hazard ratio 1.25, p-value 0.36). The nature and incidence of adverse events in the talactoferrin arm were similar to that of placebo.
Final data reported in Phase I/II study evaluating talactoferrin\'s potential to prevent nosocomial infections in pre-term infants
The Company also reported final data from a Phase I/II randomized, placebo-controlled trial, funded by a U.S. National Institutes of Health (NIH) grant, evaluating talactoferrin\'s potential to reduce the incidence of nosocomial (hospital acquired) infections in infants born prematurely, which was the primary endpoint. The study enrolled a total of 120 patients. Ten percent of patients (6 of 60) in the talactoferrin arm developed nosocomial infections compared to fifteen percent (9 of 60) in the placebo arm. This difference, while in favor of talactoferrin, was not statistically significant. The nature and incidence of adverse events in the talactoferrin arm were generally similar to that of placebo and consistent with expectations for the population under study.
Final data from halted OASIS Phase II/III trial in severe sepsis presented at ISF Sepsis 2012
Final data from the halted OASIS Phase II/III trial evaluating talactoferrin in adult patients with severe sepsis were presented in November at the International Sepsis Forum Sepsis 2012 meeting. Data presented included 28-day and three-month all-cause mortality. As previously reported, talactoferrin did not improve 28-day all-cause mortality, the primary endpoint of the study, nor did it improve mortality at three months. The most commonly reported adverse events in the study were in line with those that generally occur with sepsis patients in the intensive care unit and were generally similar between placebo and talactoferrin.
explanation for the outcomes of these recent clinical trials. If the hypotheses generated from these analyses can be confirmed by additional research, a new development path forward for talactoferrin may be considered. The company will further update the market as soon as it is in a position to do so.
