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| |  Phase I Trial of Oral Influenza Vaccine Begins LONDON-- Nov. 29, 1996 -- Cortecs International (NASDAQ:DLVRY / LSE:COR / ASX:CRI) the UK based pharmaceutical company, has announced today that it has commenced Phase I trials of its Flustat oral influenza vaccine. The vaccine is in development at the Australian Institute of Mucosal Immunology ("AIMI") in Newcastle, New South Wales. Today's announcement follows the one made on November 12, 1996 that positive data had been obtained from an interim analysis of Cortecs' ongoing double-blind Phase II clinical trial in chronic bronchitis with its most advanced mucosal vaccine, Pseudostat. Flustat Oral mucosal vaccines are designed to generate protective and therapeutic responses at mucosal sites throughout the body. Cortecs has proprietary oral delivery systems which it is employing for the development of therapeutic vaccines to treat infection of the respiratory tract, female genital tract and gastro-intestinal tract. Unlike traditional vaccines, mucosal vaccines may be used to treat existing chronic infections which fail to respond to antibiotics. Flustat oral vaccine is killed influenza virus in a proprietary delivery system, designed to stimulate an immune response in the nose and the lungs. In animal tests, Flustat has demonstrated that it can stimulate an immune response in the respiratory tract of mice which protects the animal against challenge with live influenza virus. The Trial This Phase I trial will include 40 healthy subjects, divided into four groups of ten, to investigate the preferred vaccinating regime. The trial is designed to evaluate the systemic and mucosal immune responses following oral vaccination which should show whether the oral vaccine enables the human subject to mount a rapid defensive response when challenged with the influenza virus. Animal tests have demonstrated good protective responses with this oral vaccine and remarkably also showed protection from challenge with viruses representing the main sub-strains of Influenza A virus which have occurred since 1918. Results from the clinical study are expected during the first half of 1997. Dr Michael Flynn, President of Cortecs, commented: "We have been working on the delivery system for this project for a number of years and this is a very important step for us. Conceptually an oral vaccine designed to produce a mucosal response should be more effective than current injectable vaccines and should have significant benefits of reduced side effects and better compliance. If we obtain a clear protective response in this first trial, it will give us considerable encouragement that such a vaccine would be efficacious in the general population. It is estimated the world market for injectable influenza vaccines is more than US$500 million per annum and we believe that this would increase if better and more easily administered vaccines were available." Professor Robert Clancy, Director of the Australian Institute of Mucosal Immunology (AIMI), added: "To deal effectively with influenza, one needs to enable the body to rapidly generate a protective response at the site where the virus attacks. Cortecs' oral flu vaccine is a mucosal vaccine designed to generate such a response within the mucosa which lines the respiratory tract. I strongly believe that at last we could have a user-friendly and more efficacious vaccine by this method." Cortecs International Cortecs International is a British-based company quoted on the London Stock Exchange, the Australian Stock Exchange and on Nasdaq. The Company specializes in the development of new pharmaceutical delivery systems, new oral mucosal vaccines 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/III. -- 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 H. pylori. In the market. A rapid saliva test in development. A 'one-step' whole blood test for the detection of H. pylori. In development. -- Oral Therapeutic Vaccine - in development. -- Oral Therapeutic - in research to improve eradication results. DIABETES -- Glycosal - three rapid doctors' office tests in collaboration with Exocell to assist in the management and identification of diabetes. In development. -- Oral Insulin - In Phase I trials. -- Neurulin - A topical product to treat diabetic neuropathy. In Phase II testing. CYSTIC FIBROSIS & CHRONIC BRONCHITIS -- Pseudostat - oral therapeutic vaccine to treat and prevent lung infection with Pseudomonas aeruginosa now in Phase II trials. INFLUENZA -- Flustat - an oral vaccine against influenza in Phase I trials. TUBERCULOSIS -- ELISA tests to provide hospitals and laboratories with Serodiagnostic procedures. In development. -- Rapid point-of care self-contained diagnostic kits, designed for use without any special training. In development. THRUSH -- Moniliastat - an oral therapeutic vaccine against vaginal thrush. Enters human trials in current financial year. MALE HORMONE DEFICIENCY -- Halo Testosterone - an oral male hormone replacement therapy in development to treat male hypogonadism. Cortecs also markets a range of ethical and OTC medicines and diagnostic products.
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