Date: 2012-02-02
Type of information:
phase: 2-3
Announcement: cessation of patient enrollment
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: Western Europe, North America
Trial
details: The OASIS trial is evaluating talactoferrin plus standard care compared to placebo plus standard care in adult patients with severe sepsis. The Phase II part of the trial is planned to enroll approximately 350 patients at clinical sites predominantly in Western Europe and North America. The study’s primary objective is to determine the effect of talactoferrin on 28-day all-cause mortality. Secondary endpoints include three-month, six-month and twelve-month all-cause mortality. The study will also evaluate the safety and tolerability of talactoferrin in this patient population, and data will be collected to further elucidate the mechanism of action of talactoferrin.
Latest
news: Agennix AG has announced that, upon the recommendation of the study Data Safety Monitoring Board (DSMB), the Company has stopped further enrollment and treatment in the Phase II/III OASIS trial with talactoferrin in severe sepsis. The DSMB made this recommendation based on a
review of the available data from the trial, which indicated that 28-day mortality in the talactoferrin arm of the study was greater than in the placebo arm. The first patient has been dosed last June (See http://biopharmanalyses.fr/clinical-trails/?pageid=511).
Agennix is unblinding the data from the trial to better understand these results. A review will be initiated immediately, and, once completed, the Company will determine its next steps regarding the development of talactoferrin in severe sepsis and provide additional information regarding the results of the study. Based on the available information, these results should have no impact on the conduct of the ongoing FORTIS-M trial with talactoferrin in non-small cell lung cancer.
