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Results From Phase II Trial in Critical Care Medicine Showed Eritoran Tetrasodium (E5564) To Be Well Tolerated in Patients with Severe Sepsis
Date:12/22/2009

ant (p=0.34), the difference in mortality between the high-dose group and placebo was 6.7%.

The greatest benefit was observed in the population at the highest risk of mortality as assessed by APACHE II Predicted Risk of Mortality (PROM). In patients who were considered at higher risk of death, mortality among placebo patients was 56.3% versus 33.3% in high-dose patients (p=0.105).

About ACCESS

Based on the trial results, Eisai is now conducting a global Phase III clinical trial program, called ACCESS (A Controlled Comparison of Eritoran tetrasodium and Placebo in Patients with Severe Sepsis). The trial will further evaluate eritoran as a potential treatment for severe sepsis, the second most frequent cause of death in intensive care patients in the U.S., surpassed only by cardiovascular events. In the European Union (EU), sepsis is the most common cause of death in the ICU.

The ACCESS trial population will enroll substantially more patients than the Phase II trial and has been sized (n=2,000) to determine the efficacy (reduction in 28-day all-cause mortality) of eritoran and 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 ICUs.

About Eritoran, TLR4 and Severe Sepsis

Sepsis is a condition involving infection and inflammation. The body's normal response to an infection is to initiate an immunological chain reaction of inflammation. In severe sepsis, systemic inflammation may be an overreaction leading to injury and failure of one or more organ systems that may become life-threatening. The toll-like receptor 4 (TLR4) is part of the innate immune system and, when it is activated, TLR4 may play an important role
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SOURCE Eisai
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