Agennix AG Halts Phase II/III OASIS Trial in Severe Sepsis
PLANEGG, GERMANY and MUNICH, GERMANY, Feb 02, 2012 (MARKETWIRE via COMTEX) -- Agennix AG (frankfurt:AGX) (xetra: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."
Agennix AG is a publicly listed biopharmaceutical company that is focused on the development of novel therapies that have the potential to substantially improve the length and quality of life of critically ill patients in areas of major unmet medical need. The Company's most advanced program is talactoferrin, a first-in-class oral Dendritic Cell Mediated Immunotherapy (DCMI). Talactoferrin is currently in Phase III clinical trials in non-small cell lung cancer. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase I testing for cancer, and a topical gel form of talactoferrin for diabetic foot ulcers. Agennix's registered seat is in Heidelberg, Germany. The Company has three sites of operation: Planegg/Munich, Germany; Princeton, New Jersey and Houston, Texas. For additional information, please visit the Agennix Web site at www.agennix.com .
This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. The achievement of positive results in early stage clinical studies does not ensure that later stage or large scale clinical studies will be successful. Even if the results from our later stage trials with talactoferrin, including the ongoing FORTIS-M trial in non-small cell lung cancer, are considered positive, there can be no guarantee that they will be sufficient to gain marketing approval in the United States or any other country, and regulatory authorities may require additional information, data and/or further pre-clinical or clinical studies to support approval. In such event, there can be no guarantee that the Company will have or be able to obtain the financial resources to conduct any such additional studies or that such studies will yield results sufficient for approval. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Agennix(TM) is a trademark of the Agennix group.
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SOURCE: Agennix AG