Anti-Pseudomonas IgY
Immunotherapy with IgY is by design a low toxicity treatment and is therefore ideally suited for long term prophylaxis, even more so for conditions where it is simply not possible to stay away from the microorganisms that cause the infection.
Anti-Pseudomonas IgY is a solution with antibodies specifically targeting Pseudomonas aeruginosa. The solution, which is produced out of eggs from hens, gives a protection against the bacteria in the mouth and throat which prevents the bacteria from further infecting the lower airways.
Since the “intake” of PA will be fairly constant, it seems likely that a daily long-term treatment is needed to counteract a possible build-up of PA. Anti-Pseudomonas IgY is ideally suited for long term prophylactic treatment since it is a natural and safe solution that can be given daily without any side-effects. Benefits seen with Anti-Pseudomonas IgY:
- Spreads the time between Pseudomonas infections
- Delays the onset of chronic infections
- Reduces the usage of antibiotics
- Can be taken daily without any side-effects
- Bacteria can not develop resistance against Anti-Pseudomonas IgY
- Reduces the number of days that patients are hospitalized
Anti-Pseudomonas IgY is contract manufactured at Fresenius Kabi, Sweden, according to general GMP guidelines. Discussions are ongoing with the European Medicines Agency, EMEA, for the continued development of Anti-Pseudomonas IgY and for setting up a phase III study.
Licensing
Based on reported results from preclinical and clinical studies, the Swedish Medical Products Agency in November 2003 gave special permission to CF patients with intermittent but still not chronic PA infections to be treated with Anti-Pseudomonas IgY. -Studies on a number of patients carried out over several years show that the number of infections caused by Pseudomonas aeruginosa decrease considerably when patients are treated with Anti-Pseudomonas IgY, states Professor Hans Kollberg of Akademiska Hospital in Uppsala. Furthermore, the use of antibiotics is reduced correspondingly and patients feel well and retain their lung function.
The Swedish government reimburses this treatment under the condition that the patients are followed with the same arrangements as in the first feasibility study.
For questions regarding licensing of Anti-Pseudomonas IgY, please contact per.omstedt@immunsystem.se
