Cortecs announces positive preliminary Phase I/II results for "Pseudosat" oral vaccine against pseudomonas.

LONDON--(BUSINESS WIRE)--November 14, 1995--Cortecs International (NASDAQ:DLVRY/LSE:COR.L/ASX:CRI)("Cortecs") today announces the preliminary results of its Phase I/II study in bronchiectasis of Pseudostate, its oral vaccine against pseudomonas infection of the lung, which the company commenced in March 1995.

Analysis of the total results is continuing and there should be more to report early in 1996.

The preliminary analysis 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. Also in this study, 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.

This open Phase I/II study was carried out in Newcastle, NSW, Australia at Cortecs' Australian Institute for Mucosal Immunology (AIMI) in 10 patients with bronchiectasis (a disease of the lungs in which the structure of the bronchi, the tubes lining the lungs, is distorted so that bronchial secretions cannot easily be expelled and then become infected and very difficult to treat).

Pseudomonas aeruginosa is the organism responsible for 90% of the deaths in cystic fibrosis patients who usually become colonized in early childhood. Antibiotics become less effective as lung damage progresses and there are currently no vaccines available. These results 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. This oral vaccine is being developed for the management of these diseases and Phase II trials in both cystic fibrosis and chronic bronchitis are scheduled to begin in 1996.

Dr. Michael Flynn, president of Cortecs commented: "This trial so far has shown results which are everything we could have hoped for and give us reason to believe we are certainly on the right track for producing an oral vaccine against Pseudomonas auruginosa infection which could be used both to treat and prevent this serious and problematic infection."

Prof. Robert Clancy of AIMI said: "A major outcome of this study was the consistent demonstration, for the first time, of specifically reactive "T" lymphocytes. It is these cells in experimental bronchitis that mediate enhance clearances of bacteria from the sputum."

Cortecs is a British-based company quoted on the London Stock Exchange, Nasdaq and the Australian Stock Exchange. The company specializes in the development of new pharmaceutical delivery systems and rapid point-of-care diagnostics for the healthcare industry. Other major areas include:

-- Oral Calcitonin - a system has been developed for the oral delivery of biotechnology drugs such as Calcitonin, which is a treatment for the bone-wasting condition Osteoporosis, and which is presently in Phase II clinical trials.

-- Oral pseudomonas and Flu Preventatives and Treatments - orally delivered treatments against diseases such as influenza and also pseudomonas infection (in cystic fibrosis) which is currently in Phase I/II trials.

-- Oral Anti-Diarrhoeal - an oral system to prevent diarrhoea without antibiotics.

-- Point-of-Care Diagnostics - a range of innovative diagnostic kits including:

- HELISAL - rapid doctor's office test for the detection of Helicobacter pylori.

- A rapid doctor's office test in development to detect bone breakdown indicating the presence of the disease Osteoporosis.

- A rapid doctor's office test in development to assist in the monitoring of the medium and longer-term control of diabetes.

Cortecs Healthcare markets a range of ethical and OTC medicines and diagnostic products.

CONTACT: Cortecs International Limited

Jonathan Pockson

011-44-181-568-7071

or

Buchanan Communications

Zena Bates

011-44-171-248-3780

or

Kehoe, White, Savage & Co., Inc.

Van Negris

212/888-1616