Eisai Company, Ltd. (ESALY.PK) To Delay Application For Sepsis Drug Eritoran
WOODCLIFF LAKE, N.J., March 25 /PRNewswire/ -- Eisai Inc. announced today that the Phase III ACCESS (A Controlled Comparison of Eritoran and Placebo in Patients with Severe Sepsis) trial of the investigational compound eritoran (E5564) will continue enrolling to the preset goal of 2,000 patients. As part of a planned interim analysis, an independent Data Monitoring Committee (DMC) has evaluated efficacy and safety data on the first 1,500 subjects to complete the 28-day follow-up in the Phase III ACCESS trial. After evaluating the efficacy and safety data, the DMC recommended continued enrollment to the planned goal of 2,000 patients, according to the current protocol. In addition, the DMC did not express safety concerns that would warrant stopping the trial at this time.
Discovered and developed by Eisai, eritoran is believed to block activation of toll-like receptor 4 (TLR4). TLR4 is part of the innate immune system and, when it is activated, TLR4 may play an important role in the course of severe sepsis.
Eisai's research and development efforts regarding eritoran and severe sepsis illustrate the company's human health care mission, which is to address unmet medical needs and increase benefits to patients and their families.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.
For more information regarding eritoran or ongoing clinical trials, please contact Eisai Medical Services at 1-888-422-4743