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Results from phase III trial for Anti-Pseudomonas IgY

The placebo controlled clinical phase III study of Anti-Pseudomonas IgY has been finalized. The study started in 2011 and involved patients at 49 sites in 9 European countries and more than 150 cystic fibrosis patients were enrolled. The outcome of the study is that no difference was seen between the treatment and placebo groups. This held true for the primary and all secondary endpoints, so the results were conclusive. Despite all of the above mentioned results, it can be noted that the desired time to re-infection for the treatment was reached, but the time to re-infection was the same for the placebo. This can have multiple meanings, but the main result is still negative for the investigated drug Anti-Pseudomonas IgY.
This is an unexpected result for Immun System and the company has discontinued licensing and development of the product Anti-Pseudomonas IgY.


 


Orphan drug Designation for Anti-Pseudomonas IgY

Swedish biotech company IMMUNSYSTEM I.M.S. AB announces that the European Medicines Agency, EMEA, has granted an orphan drug designation to the drug candidate Anti-Pseudomonas IgY for use in the treatment of cystic fibrosis.

pdf document Orphan drug announcement (English)

 


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.

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Cystic Fibrosis

Cystic fibrosis is one of the most common life-shortening, childhood-onset inherited diseases and in caucasian populations, it is the most common life-shortening genetic disease.

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