Eisai to Continue Eritoran (E5564) Phase III Severe Sepsis Trial, Based on Interim Analysis That Evaluated Efficacy and Safety Data

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.

The ACCESS trial is a global, randomized, double-blind, placebo-controlled trial evaluating eritoran as a potential treatment for severe sepsis. The ACCESS trial targets a population with severe sepsis that has a moderate-to-high risk of mortality as determined by baseline APACHE II (Acute Physiology and Chronic Health Evaluation II) scores from 21 to 37. APACHE II is a severity of illness scoring system commonly used in sepsis research and intensive care units (ICU).

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.

Each year, severe sepsis strikes approximately 750,000 people in the US alone, - more than breast cancer, colon cancer and AIDS combined - with a mortality rate of 30-35 percent (depending on population studied). Worldwide, sepsis affects 18 million people every year.

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 Inc.

Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales).  The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2008 (year ended March 31, 2009) sales of approximately $3.7 billion.  Eisai Inc.'s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care.  The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.  

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.

*On October 1, 2009, Eisai Research Institute of Boston, Inc. (established in 1987) and Eisai Medical Research Inc. (established in 2002) were merged into Eisai Inc.

For more information regarding eritoran or ongoing clinical trials, please contact Eisai Medical Services at 1-888-422-4743.

SOURCE Eisai Inc.



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