Scientists at Biocontrol have presented at the Bacteriophage 2008 meeting in Hertfordshire a first look at the results of their initial Phase II clinical trial
The use of natural controls against serious bacterial infection and superbugs is being led by a UK company.
This is the first fully-regulated clinical trial to test whether phage therapy really works and it shows positive results for Biocontrol's innovative treatments, which attack and destroy previously untreatable bacterial infections.
Set up in 1997, Biocontrol has been developing the clinical use of bacteriophages - literally eaters of bacteria - that attack dangerous infection-causing bacteria.
First discovered in the early 20th century, bacteriophages, or phages, are naturally occurring viruses that attack and destroy harmful bacteria.
They are highly specialised, usually attacking only specific strains of a single species of bacteria.
Biocontrol's clinical trial has been testing a treatment against the Pseudomonas aeruginosa bacteria - which is highly and increasingly resistant to traditional antibiotics and is a potential killer, especially when it infects the lungs - a future target for the company.
Pseudomonas aeruginosa is also a major cause of ear infections, including the outer ear infection known as swimmer's ear.
Over a period of 17 months, from July 2006 to November 2007, a double-blind Phase II clinical trial took place at a specialist London hospital involving 24 patients with chronic ear infections that were not responding to antibiotic treatments.
Results reported by both the patients who received Biocontrol's phage treatment and the medical staff treating them, showed improvements.
This amounted to a mean 50% reduction in symptoms, compared to a mean of only 20% in the control group who did not receive phages.
Among the most striking of the trial's findings were the bacterial counts, analysed from samples taken from patients' ears at periods of one, three and six weeks after the treatments were applied.
In the test group of patients, the mean count of Pseudomonas aeruginosa bacteria present dropped by an average of around 80% by week three, and stayed there.
By contrast, in the control group, the mean levels of bacteria showed a small increase over the same period.
Biocontrol's founder and chief scientific officer, David Harper, commented: "This is the first fully-regulated double-blind clinical trial of the efficacy of a phage treatment, and is exactly what is needed to find out whether such a treatment really works.
"The fact that patients seem to have been getting better is the most exciting thing.
"Obviously a major part of the trial was monitoring to ensure that the treatments were safe - and there were no reportable safety events throughout, another very positive result".
Originally designed for 40 patients, the trial was halted after 24, as patients seemed to be getting better.
The company, working with the clinicians in charge, has decided to move on with bringing such a potentially important treatment to the market as quickly as possible.
We are also planning to offer phage treatment to the patients who did not receive it during the trial".
Commenting on the successful outcome, the clinical director of the trials, Professor Tony Wright, consultant ENT surgeon at the Royal National Throat, Nose and Ear Hospital in London, said: "All the patients had long histories of ear problems that had failed to respond to all sorts of treatments including topical and oral antibiotics, and sometimes even surgery.
"Some had had problems for more than 40 years".
The next step for Biocontrol is to obtain permission for the pivotal Phase III clinical trial for the treatment that has now completed the Phase II trial.
Dr Harper said: "We want to get the Phase III trial for the ear treatment up and running as soon as possible.
"In addition, Pseudomonas aeruginosa bacteria are particularly dangerous when infecting the lungs of patients with cystic fibrosis.
"80% of adult CF sufferers have chronic lung infections and it is the major cause of death in these patients.
"We are currently working on the development of an aerosol treatment that we hope will also produce a positive outcome in trials that we plan to start in late next year.
"We are also fundraising now to be able to take these trials forward, and are considering an IPO in 2009 to secure the levels of investment needed to take our products to market".
Biocontrol is based in London, and as part of ongoing expansion, the company has recently opened laboratories in Nottingham, close to the planned centre for next year's trial.
It has taken space in the BioCity complex - the leading centre for bioscience and healthcare sector companies in the East Midlands.
Welcoming Biocontrol, BioCity Nottingham's chief executive officer, Glenn Crocker, said: "We are delighted that Biocontrol has joined us at BioCity Nottingham.
"It is exactly the sort of fast growing company, developing truly innovative healthcare products that we were established to attract.
"Everyone is aware of the problems dealing with bacterial infections and Biocontrol's products are increasingly being shown to be an effective solution".
Note: The information contained here relates to the outcomes of an initial (Phase 1/2) clinical trial.
The experimental treatment referred to will require successful completion of additional, large scale trials before being the subject of application for marketing approvals by appropriate regulatory bodies.
It will not be available for the general treatment of patients until such a process is completed.
