Biocontrol Ltd (UK) presents data from First Superbug Clinical Trial
Technology to defeat bacterial infections shows positive results
The use of natural controls against serious
bacterial infection and superbugs is being led by a
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, Dr 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
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
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.”
Regulatory note: The information contained in this release 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.
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