Cortecs commences Phase II oral pseudomonas vaccine trials in patients with cystic fibrosis.

LONDON, England--(BUSINESS WIRE)-- July 30, 1996--Cortecs International (NASDAQ:DLVRY/LSE:COR/ASX:CRI) today announced that it has commenced its first Phase II trial for Pseudostat in patients with cystic fibrosis. This follows Cortecs announcement on July 24, 1996 regarding the commencement of two Phase II trials of its oral Pseudostat therapeutic vaccine against Pseudomonas aeruginosa in patients with chronic bronchitis.

The trial in Melbourne, Australia, involves forty adult cystic fibrosis patients whose lungs are colonized (infected) with Pseudomonas aeruginosa. Patients will be given a course of Pseudostat tablets and their response monitored for a period of twelve months from the date of first tablet taking. The aim of the study is to evaluate the effect of such immunization on the number of infective episodes, the level of bacterial colonization, immunological response, lung function and safety. Further clinical trials involving a much larger number of cystic fibrosis patients are also planned to commence later this year.

Cystic fibrosis is the most common lethal genetic disease in Western countries, occurring in about 1 in 2,500 births in Caucasians. Between two to four percent of all persons of Northern European descent carry the gene for cystic fibrosis and in the U.S. alone there are approximately 30,000 patients with cystic fibrosis. The disease causes the bronchial secretions to be very thick and difficult to clear from the lungs. This leads to areas of blockage which permit infections with Haemophilus influenza and Staphylococcus aureus bacteria and subsequent infection with Pseudomonas aeruginosa. Infection with Pseudomonas aeruginosa is more serious. It causes more rapid deterioration and damage to the lungs. This in turn causes progressive loss of respiratory function leading to death through respiratory failure in the majority of cystic fibrosis patients.

Pseudomonas aeruginosa is a pathogen which is very difficult to eliminate in patients with chronic lung diseases. The presence of this organism often heralds a much more aggressive progression of the disease. Animal tests with Pseudostat show that, in a challenge model, the oral vaccine provides protection against infection with Pseudomonas aeruginosa. Unvaccinated animals suffered 100 percent mortality within twelve hours but animals vaccinated with Pseudostat suffered no mortality.

Cortecs also recently announced positive preliminary results in an open Phase I/II study of patients with bronchiectasis (a disease of the lungs). Preliminary analysis showed that after oral vaccination with Pseudostat a 70 percent reduction of infection was achieved with a similar reduction in the need for treatment with antibiotics which are the main treatment for chronic lung infection. Antibiotics are not always successful in treating chronic lung infections and carry the risk of allowing the development of antibiotic resistant strains of pathogens. The advantage of oral mucosal vaccines is that the body's own immune system is specifically stimulated to prevent further episodes and to fight existing mucosal infections.

Commenting on the announcement, Dr. Michael Flynn, President of Cortecs, said: "Pseudostat originated from the Australian Institute of Mucosal Immunology ("AIMI") which is based at the University of Newcastle, New South Wales, Australia. AIMI is the longest established member of Cortecs' R & D network of collaborative centers of excellence. Pseudostat belongs to a new class of vaccines called mucosal vaccines. These can be administered by mouth and act by presenting the antigens (vaccine) to specialized cells within the intestine which pick up small particles and can process them into the immune system to stimulate a defensive response at mucosal sites elsewhere in the body. Mucosal sites 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. Cortecs' previous animal studies and recent Phase I/II trial in bronchiectasis patients demonstrated that mucosal vaccines provide real prospects for treating and preventing a variety of chronic infections of mucosal surfaces including Pseudomonas aeruginosa infections."

Dr. John Wilson, Principal Staff Physician, Department of Respiratory Medicine at the Alfred Healthcare Group and Monash University Medical School, Melbourne, added: "The treatment of resistant Pseudomonas species remains one of the greatest hurdles in the management of cystic fibrosis. This study could potentially lead to significant advances in treatment of cystic fibrosis." "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Some or all of the statements in this release that relate to future plans, expectations, events, performance and the like are forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Actual results or events could differ materially from those described in the forward-looking statements due to a variety of factors, including those set forth in the Company's filings with the Securities and Exchange Commission.

Cortecs 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 and 'point-of-care' rapid diagnostics which provide the opportunity to advance the management of serious diseases such as:

-- OSTEOPOROSIS o Oral Calcitonin- an oral therapy for the

prevention of bone breakdown. In Phase II

trials.

o 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.

-- PEPTIC ULCERS

& GASTRITIS o Helisal(TM)- a rapid doctors' office whole

(H. PYLORI) 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.

o Oral Therapeutic in research to improve

eradication results.

-- DIABETES o Oral Insulin- human tests planned in 1996.

o Glycosal- a rapid doctors' office test to

assist in the management and identification

of diabetes. In development.

-- CYSTIC FIBROSIS

& CHRONIC o Pseudostat- oral therapeutic vaccine to treat

BRONCHITIS and prevent lung infection with Pseudomonas

aeruginosa. In Phase II trials.

-- INFLUENZA o Flustat- an oral vaccine against influenza

entering human trials in 1996.

-- THRUSH o Moniliastat- Oral therapeutic vaccine against

vaginal thrush. Enters human trials in 1996.

-- MALE HORMONE

DEFICIENCY o 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.

NOTE: Press releases and other Cortecs International Limited information are available on the Cortecs International Limited web site: http://www.cortecs.com.

CONTACT: Dr. Michael Flynn, President

Cortecs International

0181 568 7071

or

Zena Bates 

Buchanan Communications

0171 489 1441

or

John P. Kehoe/Van Negris

Kehoe White, Savage & Co., Inc.

[phone]