AGENNIX AG HALTS PHASE II/III OASIS TRIAL IN SEVERE SEPSIS
Planegg/Munich (Germany), February 2, 2012 – Agennix AG (Frankfurt Stock Exchange (Prime Standard): AGX/ISIN DE000A1A6XX4) 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.
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.
“We are extremely disappointed and surprised by this result,” said Rajesh Malik, M.D., Chief Medical Officer of Agennix. “Given the challenge of treating this life-threatening condition, we had made the decision prior to initiating the OASIS trial to obtain additional clinical data before entering a large Phase III study.
We will look closely at the data to better understand these results and to determine the best next steps related to further development of talactoferrin for the treatment of severe sepsis.”