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RIBI IMMUNOCHEM: STUDY TO DETERMINE ABILITY OF MPL(R)-C TO REDUCE HEART MUSCLE DAMAGE ASSOCIATED WITH BYPASS SURGERY

 HAMILTON, Mont., Aug. 10 /PRNewswire/ -- Enrollment has been initiated in a Phase II human clinical study to evaluate the prophylactic use of MPL(R)-C immunomodulator in heart bypass patients to prevent or reduce post-ischemic cardiac dysfunction, Ribi ImmunoChem Research Inc. (NASDAQ: RIBI) announced today.
 The Phase II clinical testing of MPL-C in coronary artery bypass graft (CABG) surgery patients at risk of experiencing post-bypass ischemia-reperfusion dysfunction will be conducted at up to four study centers. The study, which is randomized, placebo-controlled and double-blinded, involves approximately eight dose levels of MPL-C administered to patients prior to CABG surgery. Up to 48 patients will be enrolled; each dose level is expected to accrue six patients.
 "Animal studies to date have suggested positive benefits; we are hopeful these observations can be duplicated in humans," said Robert E. Ivy, chief executive officer, president and chairman. "We will use this study to assess the safety and biological activity of MPL-C in this patient group. The data will also be used to help determine appropriate endpoints for larger-scale controlled Phase II and pivotal Phase III testing if this study is successful. Such endpoints may include global cardiac function following surgery, post-operative arrhythmias and infarct rate."
 Cardiac ischemia-reperfusion dysfunction is believed to occur 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 animal 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 in one model system. Further, in a separate animal model, MPL-C improved the rate of recovery of cardiac contractility by apparently protecting against cardiac stunning (reversible damage that reduces the contractility of the heart muscle caused by a brief period of ischemia followed by reperfusion). In one animal model, MPL-C was found to enhance preservation of the energy charge in myocardial tissue and in a second animal model reduced infiltration by 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.
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 /CONTACT: Jeffrey S. McDowell, corporate information manager, of Ribi ImmunoChem Research, 406-363-6214, ext. 153/


CO: Ribi ImmunoChem Research ST: Montana IN: MTC SU:

SB -- SE001 -- 1068 08/10/93 09:20 EDT
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Publication:PR Newswire
Date:Aug 10, 1993
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