INDIANAPOLIS, IN-Eli Lilly has stopped enrollment in a Phase III clinical trial investigating the therapeutic potential of recombinant, human-activated protein C in the treatment of severe sepsis. The decision was based upon the recommendation of an independent Data and Safety Monitoring Board (DSMB) that was conducting a regularly scheduled interim analysis. The DSMB found positive trial results that met the pre-determined criteria for reduced mortality.
According to August M. Watanabe, MD, executive vice president, science and technology for Lilly, no pharmacological agents are currently approved to treat sepsis, a disease characterized by an overwhelming systemic response to infection, which can rapidly lead to organ failure and death. Sepsis has a 30 to 50% mortality rate and often occurs in hospitalized patients. It is the leading cause of death in non-coronary intensive care units in the US.
Researchers have found that sepsis patients have a very low amount of protein C. When protein C levels are low, the body cannot convert much of it to the activated form, APC. Hence, coagulation and inflammation are "unchecked," resulting in serious complications. Lilly researchers believe their manufactured protein will prevent clot formation, break up clots already in existence, and reduce the inflammation that occurs in blood vessels.
If results of the full evaluation support an application and consequent receipt of approval from the Food and Drug Administration, Lilly management will market the protein as Zovant(TM).