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| |  Pre-Clinical Study Shows Apanol Reduces Early And Late Phase Asthma VANCOUVER, B.C., May 28, 1997 -- Positive preclinical results were announced today by Inflazyme Pharmaceuticals Ltd. For its lead product, Apanol(TM), in preventing the bronchoconstriction associated with both the early and late phase of an asthma attack. Analysis of the data shows that acute dosing of Apanol protected against 90% of the bronchoconstriction associated with the late phase of an asthma attack. Chronic dosing reduced both early phase bronchoconstriction by 90% and late phase bronchoconstriction by about 95%. Apanol is the first of a series of new proprietary products developed by Inflazyme that prevent inflammation and disease by inhibiting a key transcription factor, NF-kB. The study, conducted at Mount Sinai Hospital in Miami Beach, Florida, measured bronchoconstriction and hyper-responsiveness in two groups of sheep. One group received Apanol 30 minutes prior to being challenged with asthma-inducing allergens, followed by a second dose of Apanol four hours later. The second group received one dose of Apanol daily for four days, 30 minutes prior to being challenged with asthma-inducing allergens. In each group, researchers measured bronchoconstriction and responsiveness to external stimuli against historical responses recorded several weeks prior to the test. For each group, Apanol was well tolerated and decreased bronchoconstriction. Apanol also reduced the hyper-responsiveness, or sensitivity, in the lungs, that is characteristic of asthma attacks. The sheep model for asthma simulates the classic characteristics of asthma in humans, and has been used to evaluate the therapeutic potential of many current anti-asthma agents. "This study is an important milestone as we prepare for human trials of Apanol, which are expected to begin in 1998," said Hassan Salari, Ph.D., Inflazyme President and CEO. "In these studies, Apanol was several times more potent in inhibiting asthmatic reactions in the sheep model than Cromolyn, a currently used anti-asthma drug. Furthermore, Apanol was also as efficacious in sheep as steroid treatments, but Apanol does not appear to cause any of the steroid side-effects." Currently, the main treatment for asthma is steroids, which are associated with several side effects. Asthma attacks occur in two stages. The first stage is characterized by rapid airway constriction and obstruction by mucosal agents over a period of minutes. The second stage of asthma occurs 6-10 hours after the initial attack, resulting in air passage narrowing and the inflammatory production of mucus. It is the second phase of asthma that is most damaging, as the inflammation occurs on a cellular level and becomes a self-perpetuating cycle of attacks followed by an increased sensitivity to the external stimuli, which will lead to another asthma attack. Asthma affects 13 million people in the United States alone. The worldwide number of asthma patients is estimated to be over 300 million. Inflazyme Pharmaceuticals Ltd. is an emerging biopharmaceutical company specializing in the discovery, design, and commercialization of novel generations of drugs which combat major inflammatory diseases, such as asthma, allergies, arthritis, psoriasis, and a number of other illnesses categorized as inflammatory diseases.
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