Ribi ImmunoChem Research Inc. announced Tuesday that theFDA has approved its investigational new drug (IND)application for evaluating the prophylactic use of itsimmunomodulatory drug MPL-C to prevent or reduce theeffects of cardiac ischemia-reperfusion injury.
Ribi of Hamilton, Mont., plans to begin enrolling patients in thePhase II cohort study within the next 60 days. The trials incoronary artery bypass graft (CABG) patients at risk ofexperiencing post-bypass graft reperfusion injury will involveeight dose levels of MPL-C administered to patients prior toCABG surgery.
In Phase I/II trials, MPL -- or monophosphoryl lipid A, anattenuated form of the endotoxin produced by Gram-negativebacteria, and thus a potentially potent activator of the immunesystem -- was able to protect against cardiac tissue damageassociated with reperfusion injury. The data were presented inthe fall by Garrett Gross of the Medical College of Wisconsin inMilwaukee at a meeting of the American Society ofPharmacology and Experimental Therapeutics.
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