Cortecs International announces positive clinical results on second therapeutic platform.LONDON--(BUSINESS WIRE)--May 13, 1996 Cortecs International (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :DLVRY / LSE LSE - Language Sensitive Editor :COR / ASX ASX See: Australian Stock Exchange :CRI CRI constant-rate infusion. ) today announced positive final results of its open Phase I/II study in bronchiectesis of Pseudostat, its oral therapeutic vaccine against Pseudomonas Pseudomonas A genus of gram-negative, nonsporeforming, rod-shaped bacteria. Motile species possess polar flagella. They are strictly aerobic, but some members do respire anaerobically in the presence of nitrate. infection of the lung. The final results expand the preliminary analysis reported in November 1995 with evidence of a significant clinical effect. Pseudomonas aeruginosa is the organism responsible for 90% of the deaths in cystic fibrosis patients. Antibiotics become less effective as lung damage progresses and there are currently no vaccines available. The results of these trials indicate the viability of an oral vaccine for the prevention of respiratory infection with Pseudomonas in patients with serious respiratory diseases such as cystic fibrosis, chronic bronchitis and bronchiectasis bronchiectasis Abnormal expansion of bronchi in the lungs. It usually results when preexisting lung disease causes bronchial inflammation and obstruction. Bronchial wall fibres degenerate, and bronchi become dilated or paralyzed, preventing removal of secretions, which . This oral vaccine is being developed for the management of these diseases under R&D Syndication in Australia by Cortecs' Australian Institute of Mucosal Immunology ("AIMI AIMI Aviation Intensive Management Item AIMI Aviation Intensively Managed Item AIMI Advanced Integrative Medical Institute AIMI Armor, Infantry and Mechanized Infantry "). Phase II trials in both chronic bronchitis and cystic fibrosis are scheduled to begin soon. The open Phase I/II study was carried out in Australia in nine patients with bronchiectasis. This is a disease of the lungs in which the structure of the bronchi bronchi /bron·chi/ (brong´ki) plural of bronchus. Bronchi Two main branches of the trachea that go into the lungs. This then further divides into the bronchioles and alveoli. (the tubes lining the lungs) is distorted so that bronchial secretions cannot easily be expelled and then they become infected and very difficult to treat. The final result shows that, after oral vaccination, these patients exhibited a specific immune response through a type of white blood cell called "T" cells, which enables these cells to seek out and destroy the invading bacteria. Additionally, there was observed a several-fold reduction in white cell content of the sputum (white cells in sputum reflect the severity of infection, "pus" in sputum predominantly consists of dead white cells). Oral Pseudostat was given at intervals during 56 days and a progressive improvement in responses was observed. Within 28 days of discontinuing treatment, the white cells in sputum were rising again. Although this was an open study, the clinical data are encouraging. In particular the number of infections requiring antibiotic therapy was reduced by at least two thirds in the 6 months following the completion of the dosing schedule, compared to a similar period prior to taking the vaccine. Professor Robert Clancy, Director of AIMI, said: "These results confirm the preliminary evaluation of "T" cell activity and reduction of white cell content of the sputum, giving us great encouragement to enter Phase II trials. These will be conducted in patients with cystic fibrosis and chronic bronchitis." Dr. Michael Flynn, President of Cortecs, added: "We are very pleased to see these clinical and immunological responses in the open trial. This is very important as it confirms oral therapeutic vaccine delivery as a second therapeutic platform. This follows the recent report of a positive Phase II study with the first platform, oral peptic delivery, using oral calcitonin calcitonin /cal·ci·to·nin/ (-to´nin) a polypeptide hormone secreted by C cells of the thyroid gland, and sometimes of the thymus and parathyroids, which lowers calcium and phosphate concentration in plasma and inhibits bone resorption. . The longer, double-blind trials which are about to start will involve 200 patients and if positive will move us closer to our goal of a registration application for Pseudostat by the end of 1997." Cortecs is a British-based company quoted on the London Stock Exchange London Stock Exchange London marketplace for securities. It was formed in 1773 by a group of stockbrokers who had been doing business informally in local coffeehouses. , the Australian Stock Exchange Australian Stock Exchange (ASX) Australia's major securities market, formed when the six state stock exchanges (Adelaide, Brisbane, Hobart, Melbourne, Perth, and Sydney stock exchanges) were merged in 1987. and on NASDAQ. The Company specializes in the development of new pharmaceutical delivery systems and point-of-care rapid diagnostics which provide the opportunity to advance the management of serious diseases such as: OSTEOPOROSIS Oral Calcitonin - an oral therapy for the prevention of bone breakdown. In Phase II. Osteosal - a rapid doctors' office test in collaboration with Osteometer to detect increased bone breakdown indicating the risk of the disease osteoporosis and also to monitor the adequacy of therapy. In development. HELICOBACTER PYLORI Helisal - a rapid doctors' office whole blood test for the detection of Helicobacter pylori in the market and a rapid saliva test in development. Oral Therapeutic Vaccine in development to stimulate immunity. Oral Therapeutic in research to improve eradication results. DIABETES Oral Insulin - human tests planned in 1996. Glycosal - a rapid doctors' office test in collaboration with Exocell to assist in the management and identification of diabetics. In development. CYSTIC FIBROSIS Pseudostat - oral therapeutic antigens to treat and prevent lung infection with Pseudomonas aeruginosa. Entering Phase II trials in 1996. INFLUENZA Flustat - an oral vaccine against influenza. Entering human trials in 1996. THRUSH Moniliastat - an oral therapeutic vaccine against vaginal thrush. Enters human trials in 1996. DIARRHOEA Adept - an oral system to treat diarrhoea without antibiotics. Entering Phase II trials. MALE HORMONE DEFICIENCY Halo Testosterone - an oral male hormone replacement therapy Hormone Replacement Therapy Definition Hormone replacement therapy (HRT) is the use of synthetic or natural female hormones to make up for the decline or lack of natural hormones produced in a woman's body. in development to treat male hypogonadism. Entering human trials in 1996. Cortecs also markets a range of ethical and OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). medicines and diagnostic products. CONTACT: Dr. Michael Flynn Cortecs International 011 44 181 568-7071 or Van Negris Kehoe, White, Savage & Co., Inc. (212) 888-1616 or Zena Bates Bates , Katherine Lee 1859-1929. American educator and writer best known for her poem "America the Beautiful," written in 1893 and revised in 1904 and 1911. Buchanan Communications 011 44 171 489-1441 KEYWORD; NEW YORK INDUSTRY KEYWORD: MEDICINE PHARMACEUTICAL REPEATS: New York 212-752-9600 or 800-221-2462; Boston 617-236-4266 or 80 |
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