Pseudostat Cortecs Ltd.
Cortecs is developing Pseudostat, an oral vaccine derived from Pseudomonas aeruginosa, for the potential treatment and prophylaxis of lung infection with P aeruginosa and Haemophilus influenza, common in respiratory disorders such as cystic fibrosis, bronchitis and bronchiectasis. It is expected that a phase III trial will commence this year, and that a European registration submission will be made by the end of the year [262793]. In January 1998, Cortecs confirmed that phase III trials for Pseudostat for bronchitis are being prepared [276928]. Two Pseudostat phase II clinical trials commenced in July 1996 against chronic bronchitis [214837]. Results of the first trial were announced in August 1997. A total of 91 patients received Pseudostat or placebo. Five months following the completion of immunization, the number of acute infective episodes in the placebo group was about 10-fold higher than the treated group [258965]. The second study involved a total of 80 patients with chronic bronchitis, as defined by Medical Research Council criteria, but no history of consistent P aeruginosa in their sputum. The patients were followed for up to seven months after the first tablet, and efficacy outcome measures were as for the first study. Initial analysis was encouraging: after the treatment course the Pseudostat group took up no hospital days, compared to 48 days for the placebo group. Pseudostat also reduced episodes of acute infection by 90% [262793]. In July 1996, a phase II clinical trial commenced in Australia with Pseudostat in patients with cystic fibrosis (CF). The trial involved approximately 40 patients. In August 1996, the company initiated phase II trials in patients with CF in the UK [223065]. Cortecs was scheduled to begin European phase II trials for CF in the third quarter of 1997. For the US, trials for CF are planned in 1998 [259009]. An open phase I/II study has been completed in nine patients, with bronchiectasis, who after oral vaccination, twice daily for three days, starting on days 0, 28 and 56, exhibited a specific immune response. Additionally, there was a several-fold reduction in the white blood cell content of the sputum (white blood cells in sputum reflect the severity of infection). However, the white blood cell content of the patients' sputum rose again following 28 days of discontinued treatment [207633]. Phase I trials with an oral formulation were completed in healthy volunteers at the Australian Institute of Mucosal Immunology (AIMI). No adverse or toxic effects associated with Pseudostat were observed [170099].
Jones
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Head of Formulation, Centre for Applied Microbiology and Research, Experimental Vaccines Section, Porton Down, Salisbury, Wiltshire, SP4 0JG, UK. taff.jones@camr.org.uk