Date: 2011-06-30
Type of information:
phase: 2-3
Announcement: dosing of the first patient
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 has announced that the first patient has been dosed in the Phase II part of the OASIS (Oral Talactoferrin in Severe Sepsis) trial, a multicenter, double-blind, randomized Phase II/III trial evaluating the oral immunotherapy talactoferrin for the treatment of severe sepsis.
