 Clinical Trials |
| In 2004, Biocontrol successfully completed a veterinary field trial of its bacteriophage mixture against chronic Pseudomonas aeruginosa infections of the canine ear. This was reported The Lancet Infectious Diseases in September 2004 |
| In 2005, regulatory and ethical permission was obtained for a Phase I/IIa clinical trial targeting infections of the human ear with the bacterium Pseudomonas aeruginosa. |
| The trial was initiated in 2006, and completed in November 2007 at a specialist hospital in Central London. Publications arising from the trial are now in preparation. |
| Human infections of the outer ear (otitis externa, known as "swimmer's ear") are common. Pseudomonas aeruginosa is a major cause of these infections as well as of infections of the middle ear (otitis media). |
| In diabetics, malignant otitis externa and otitis media can occur leading to paralysis and can even be life-threatening. 1.25% of the population is affected by otitis every year, and of these 3% are referred to secondary care at specialist ear, nose and throat (ENT) centres. Treatment of severe or chronic otitis often requires the use of aminoglycoside antibiotics which can cause damage to hearing. As a result, there is a clear need for new approaches. |
| Following the completion of this trial, it is the intention of the company to address other therapeutic areas in which Pseudomonas aeruginosa is a major concern, notably lung infections in cystic fibrosis and infections of burns, and to seek permission for further clinical trials in these areas as and when appropriate. |
| See also: Biocontrol presents data from First Superbug Clinical Trial |