Immunoglobulin IgY pseudomonas A clinical trial for cystic fibrosis treatment
Coordinator: Anders LARSSON
Project Number: 261095
EC contribution: € 5,376,180.00
Project website: http://impactt.eu/
Cystic Fibrosis (CF) is a chronically debilitating and life threatening medical condition. Respiratory insufficiency and complications of chronic lung infection lead to long term reduction in quality of life and health and even to premature death. Chronic bacterial infections with Pseudomonas aeruginosa (PA), Staphylococcus aureus and Haemophilus influezae are typical for CF and repeated courses of antibiotics in heavy doses has more than doubled the median survival age. No preventive or eradicative treatments of PA infection in the lungs exist today. The most significant bacterial pathogen associated with CF pulmonary disease is PA. PA is an opportunistic, life-threatening gram-negative bacteria which produces various immune modulatory products enabling it to survive in the lungs and cause morbidity and mortality. CF patients are particularly at risk of infection due to the viscous mucus lining their airways, which compromises their respiratory function.
The European Medicines Agency granted ?Anti-pseudomonas IgY? an Orphan Drug Designation in September 2008, and paediatric CF product development was encouraged. The IMPACTT project will perform a clinical phase III trial, to demonstrate the critical preventive and therapeutic effects of this pioneering intervention therapy for the fatal chronic infection of Pseudomonas aeruginosa in CF patients. The project mobilises the critical mass of experts from academia, patient organisations, clinical trials managers, clinicians and industry aiming to eradicate PA infection in CF patient lungs and thereby alleviate the negative impact of PA on the quality of life of CF patients and their families.
Despite good results with antibiotics, continuous pulmonary deterioration and death of the CF patient is a reality. Alternative therapeutic strategies are badly needed. Our phase I and II clinical studies prove that a single daily gargle with the proposed Anti-Pseudomonas IgY solution significantly improves the condition.