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 DENVER, Aug. 23 /PRNewswire/ -- Cortech Inc. (NASDAQ: CRTQ) has initiated a controlled clinical trial of its bradykinin antagonist Bradycor(TM) (CP-0127) in patients with hantavirus associated adult respiratory distress syndrome (HAARDS), also known as Four Corners Disease and adult respiratory distress syndrome of unknown etiology (UARDS), Timothy C. Rodell, M.D., senior vice president, operations and product development, announced today.
 According to Rodell, the rationale for the current study is twofold. "First, bradykinin is an inflammatory mediator whose activation has been implicated in other hantaviral diseases. Second, a number of patients with presumed HAARDS already have received Bradycor, either as a result of being enrolled in the company's ongoing clinical trial in patients with presumed sepsis and the systemic inflammatory response syndrome (SIRS) or under a treatment use (also known as 'compassionate use') protocol filed earlier with the U.S. Food & Drug Administration (FDA). Because of the small numbers treated and the lack of untreated control patients, no conclusions can be drawn from these patients; however there could have been some benefit."
 The first cases of HAARDS were reported earlier in the summer in the Four Corners region of the Southwest, but suspected cases have since been reported elsewhere in the United States. Approximately 20 cases have been confirmed so far. A number of illnesses resembling HAARDS also have been reported but not yet confirmed.
 HAARDS is characterized by an initial phase which resembles a mild viral illness with fever, muscle aches and cough but is followed in many patients by rapidly progressive respiratory failure. The disease has been fatal in approximately 50 percent of cases. It is believed to be caused by a member of the hantavirus group of viruses which has caused outbreaks of disease elsewhere in the world but previously not in the United States. Hantaviruses are transmitted in rodent feces with the predominant rodent carrier in the HAARDS outbreak being the deer mouse. Public health officials have expressed concern that the incidence of the disease could increase when the weather turns colder and these rodents move indoors.
 The current trial will enroll up to 50 patients and will be placebo controlled and blinded, with one half of the patients receiving only conventional treatment and one half receiving conventional treatment plus Bradycor. None of the investigators will know which patients are receiving the drug. The major clinical endpoint for the study will be survival at 28 days.
 Rodell explained, "As is true in all such clinical studies, this type of placebo-controlled design is critical because, even though we think the drug could be life saving, we have no way of knowing at the present time whether or not Bradycor will help or harm these patients."
 The trial will be led by Dr. Howard Levy, chief of Critical Care Medicine at the University of New Mexico School of Medicine in Albuquerque who has directed the care of many of the HAARDS patients seen to date.
 Bradycor, also known as CP-0127, is a bradykinin antagonist that blocks the activity of bradykinin, a mediator produced in response to many forms of tissue injury including infections, trauma and burns. Once produced, bradykinin can cause low blood pressure or hypotension, vascular leak, tissue swelling or edema, pain and other symptoms of inflammation. Bradycor is currently in a Phase II 500-patient study of patients with presumed sepsis and SIRS, and two amendments have been filed to begin Phase II studies in patients with burns and head trauma.
 Cortech is a Denver-based biopharmaceutical company that is developing a variety of therapies for inflammatory diseases, allergies and selected autoimmune diseases. Shares of the publicly traded company are listed as CRTQ on NASDAQ.
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 /CONTACT: Timothy C. Rodell of Cortech, 303-650-1200/

CO: Cortech Inc.; University of New Mexico School of Medicine ST: Colorado, New Mexico IN: MTC SU:

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Publication:PR Newswire
Date:Aug 23, 1993

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