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RIBI IMMUNOCHEM: FDA ALLOWS IND FOR MPL-C FOR REPERFUSION INJURY INDICATION; PHASE II TESTING IN PATIENT COHORT PLANNED

 HAMILTON, Mont., May 11 /PRNewswire/ -- An Investigational New Drug (IND) application to evaluate the prophylactic use of MPL-C immunomodulator in a patient cohort to prevent or reduce the effects of cardiac ischemia-reperfusion injury has been allowed by the U.S. Food and Drug Administration (FDA), Ribi ImmunoChem Research Inc. (NASDAQ: RIBI) announced today.
 "It is most gratifying to initiate this study," said Robert E. Ivy, chief executive officer, president and chairman of Ribi ImmunoChem. "We have sufficient clinical supplies of MPL-C ready to ship, and pending institutional review of the study protocol, will begin enrolling patients within the next 60 days."
 Phase II clinical testing of MPL-C in coronary artery bypass graft (CABG) surgery patients at risk of experiencing post-bypass ischemia- reperfusion injury will be conducted at up to four study centers. The study, which will be randomized, placebo-controlled and double-blinded, will involve approximately eight dose levels of MPL-C administered to patients prior to CABG surgery.
 Cardiac ischemia-reperfusion injury occurs when the heart muscle undergoes an extended period of ischemia (deprivation of blood and thus oxygen) during an event such as a heart attack, cardiovascular surgery or cardiac transplantation, followed by reperfusion (the return of blood flow. Paradoxically, restoring blood flow may induce a complex series of events leading to both irreversible and reversible cardiac tissue damage beyond any damage that may have occurred during the ischemic period. It is believed that a significant factor in reperfusion injury is the generation of oxidative "free radical" molecules, which attack and damage cardiac tissue. Such damage may reduce cardiac function. The potential clinical application of MPL-C includes the more than 400,000 cardiovascular surgeries performed each year in the United States that require stopping the heart.
 Preclinical data indicate that administration of MPL-C prior to ischemia and reperfusion reduced cardiac infarct size (area of irreversible tissue damage) by more than 50 percent compared to a control group. Further, MPL-C improved the strength of the heart contraction by protecting against cardiac stunning (reversible damage that reduces the contractility of the heart muscle). In one animal model, MPL-C was found to increase production of a protective anti- oxidant enzyme in the cardiac cell, and in a second animal model also appeared to reduce infiltration by toxin-forming neutrophils into the border regions of the infarct area. Neutrophils are a type of white blood cell implicated in tissue damage following reperfusion.
 Ribi ImmunoChem Research Inc., a biopharmaceutical company founded in 1981, is a leader in the development of immunostimulants for use in preventing and treating human disease.
 -0- 5/11/93
 /CONTACT: Jeffrey S. McDowell, corporate information manager, of Ribi ImmunoChem Research, 406-363-6214, ext. 153/
 (RIBI)


CO: Ribi ImmunoChem Research Inc.; U.S. Food and Drug Administration ST: Montana IN: MTC SU:

LM -- SE013 -- 7239 05/11/93 16:38 EDT
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Date:May 11, 1993
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