Cortecs Pseudomonas Vaccine Starts Phase II

4 August 1996

Oral delivery specialist Cortecs International has started Phase II trials of its second major therapeutic product, Pseudostat, an oral vaccine against Pseudomonas aeruginosa infections in patients with cystic fibrosis and chronic bronchitis. The company's oral salmon calcitonin product for osteoporosis entered Phase III earlier this year.

The trial will be conducted in Melbourne, Australia, in 40 adult cystic fibrosis patients who are infected with the organism. A course of Pseudostat will be given and patients will then be monitored over 12 months to see if the vaccination has an impact on the number of infective episodes, the level of bacterial colonization, immunological response, lung function and safety. Further clinical trials involving a larger number of CF patients are also scheduled to start later this year.

Preliminary results from a recent Phase I/II study in patients with bronchiectasis revealed that oral vaccination with Pseudostat provided a 70% reduction of infection and a similar reduction in the need for antibiotic treatment.

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