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Pseudostat Vaccine Prevents Chronic Bronchitis LONDON -- August 12, 1997 -- Cortecs International today announced positive results regarding the completed Phase II trial of its oral therapeutic vaccine Pseudostat(TM) in patients with chronic bronchitis. The objective of this trial was to demonstrate clinical efficacy in chronic bronchitis patients, as defined by The Medical Research Council criteria, who have a history of two or more acute ineffective exacerbations per year. Ninety-one patients were recruited to take part in the double-blind, placebo-controlled study. The patients received a Pseudostat(TM) oral immunization course or placebo involving three days of treatment which was repeated two times at one month intervals. During the five months following completion of immunization, the number of acute ineffective episodes in the placebo group was approximately 10 times higher than in the Pseudostat group, whereas up to completion of immunization the infection rate had been similar in the two groups. 48 Hospital Bed-Days With Placebo - None With Pseudostat(TM) Following completion of the immunization course, there were only 10 days of infection in the Pseudostat group compared with 106 days of infection in the placebo group. Over the same time period, 48 hospital bed-days were occupied in the placebo group compared with none in the Pseudostat(TM) group. A full statistical report of these results will be presented during the next six weeks. "This is an exciting result as protection against infection has been solidly demonstrated in a group of patients with damaged lungs, for whom the only alternative would be repeated courses of antibiotics,” stated Professor Robert Clancy, Director of the Australian Institute of Mucosal Immunology (AIMI), where this therapeutic vaccine was conceived. "The study was designed specifically to test Pseudostat(TM) in a 'real life' situation. Pseudostat is a potent generator of protective T Lymphocytes, capable of cross-reacting with bacteria in the lungs. I believe that this could herald a new era in the management of certain chronic lung infections." Mucosal immunization is a relatively new approach to disease management. Some diseases, particularly respiratory diseases, commence through infection of the body's mucosal surfaces. Mucosal surfaces are those regions of the body which normally are moist and include the nasal passages, sinuses, middle ear, bronchi, intestines and genito-urinary tract. Usually these areas of the body are not well protected by injectable vaccines. Chronic infections of these surfaces are common and for the majority of these chronic infections, current treatment methods are inadequate. Cortecs oral mucosal delivery technology aims to stimulate the body's own defense system at these surfaces to treat these common and persistent diseases. Chronic bronchitis is characterized by persistent underlying lung infection and is a common cause of morbidity and mortality, causing 28 million lost working days and 5 percent of deaths per year in the United Kingdom alone. World-wide it is estimated that more than 5 million people suffer from the disease. It is characterized by intermittent acute episodes of infection which, unless treated promptly, may lead to further damage to the lungs and a worsening of the underlying chronic bronchitis. Cortecs is a British-based company that specializes in the development of new oral pharmaceutical delivery systems, new oral mucosal vaccines and point-of-care rapid diagnostics which provide the opportunity to advance the management of serious diseases. More information on: Cortecs International E-mail this page to a friend or colleague! To print, use this version