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.
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