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 HAMILTON, Mont., Sept. 9 /PRNewswire/ -- A patent covering the use of MPL(R)-C immunomodulator to prevent or reduce organ tissue damage caused by ischemia and reperfusion has been allowed by the U.S. Patent and Trademark Office, Ribi ImmunoChem (NASDAQ:RIBI) announced today.
 The patent, entitled "Method and Composition for Ameliorating Tissue Damage Due to Ischemia and Reperfusion," includes 12 claims covering a method for ameliorating organ tissue damage associated with a prolonged period of ischemia (stoppage of blood flow and, thus, oxygen to an organ) followed by reperfusion (return of blood flow and, thus, oxygen). Gary T. Elliott, Pharm. D., Ph.D., director of Pharmaceutical Sciences for Ribi ImmunoChem, is the first-named inventor. The company will hold 21 U.S. patents on its technology, products and applications when the MPL-C patent is issued. The company expects the patent to issue in the next few weeks.
 "We are very pleased to obtain this proprietary protection, as we are aggressively pursuing clinical development of MPL-C," said Robert E. Ivy, chief executive officer, president and chairman of Ribi ImmunoChem. "This patent helps to protect that investment."
 MPL-C immunomodulator is currently in a Phase II human clinical study to evaluate its safety and biological activity in coronary artery bypass graft (CABG) surgery patients at risk of experiencing post-bypass ischemia-reperfusion dysfunction. The study, which is being conducted at up to four study centers, is randomized, placebo-controlled and double-blinded and 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.
 "Preclinical studies to date have suggested positive benefits; we are hopeful these observations can be duplicated in humans," said Mr. Ivy. "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 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 preclinical 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 another preclinical model, MPL-C was found to enhance preservation of the energy charge in myocardial tissue and in a second preclinical 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, 406-363-6214 or Michele Fasano, of Lippert/Heilshorn & Associates Inc., 212-838-3777/

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

RB -- SE001 -- 0112 09/09/93 08:16 EDT
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Date:Sep 9, 1993

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