Vission Mission Value

Vision

To provide an intervention therapy for prophylaxis and treatment of P. aeruginosa (PA) infections in CF patients and to make this treatment available for the CF patients. In addition, IMPACTT explores ways of meaningfully involving CF patients and families into clinical CF research.

Mission

Demonstrate the clinical potential of the IgY as a CF therapeutic treatment of acute or intermittent infection:

  • To perform a phase III trial on gargling with Anti-Pseudomonas IgY, to prevent infections and treat CF-patients. To include 180 intermittently PA-infected CF-patients from several countries in Europe in the study.

Demonstrate the state-of-the-art of Anti-Pseudomonas IgY by:

  • Identifying the mechanism of action. To provide data for information on whether Anti-Pseudomonas IgY also might act as a modulator of inflammation.
  • Demonstrating that Anti-Pseudomonas IgY is not absorbed from the gastro-intestinal tract. To provide specific data on the absorption of IgY and if there is any risk for production of antibodies against IgY, which could diminish its activity.
  • Performing animal safety tests.  Anti-Pseudomonas IgY is a pure water extract of eggs and is thus a normal food component. Anti-Pseudomonas IgY has not been reported to be absorbed from the gastrointestinal tract and should therefore not give any generalized adverse events. .
  • Performing animal studies on Anti-Pseudomonas IgY effect on lungs. In vitro studies have shown that Anti-Pseudomonas IgY prevents adhesion of PA to epithelial cells and that Anti-Pseudomonas IgY binds to flagellin of PA. The long term clinical trial, which is still running, has shown a good effect for the CF-patients. An animal study will, however, be a strong complement for these studies to show the effect of Anti-Pseudomonas IgY.
  • Optimization new drug formulations. The choice will be between a gargle solution and freeze dried powder/lozenges. The spray dried powder dissolved in water will be tested in a phase I clinical trial in CF–Centre Uppsala, on about 10 patients.

Value

Clinical Study - a randomized double-blind placebo-controlled clinical study (supported by preclinical studies) with the aim is to reduce/delay the onset of new PA positive cultures.

  • 180 patients will be enrolled from six EU countries.
  • The inclusion criteria are that Patients have had PA positive culture(s), but are not chronically colonized.
  • The Patients will be given a daily treatment with Anti-pseudomonas IgY or placebo gargle until PA pos. culture (=primary endpoint), but not longer than two years.

Clinical results evaluation:

  • For PA precipitins (P. aeruginosa antibodies =precipitins): Precipitins against PA are taken to control that no PA infections have been missed in otherwise routine culture analysis in the local CF-Centers
  • For PA and other pathogens primary end-point microbiology: sputum or throat cough swab for pathogens (bacteria and fungi)
  • For anti-IgY antibodies and for the inflammatory marker CRP: inflammatory activity in patients