Micap to test MRSA-killing technology
at the heart of a new strategy for controlling
methicillin-resistant Staphylococcus aureus, the 'superbug'
that is emerging as a major threat in hospitals around the world.
A Phase I clinical trial of the product, which uses Micap technology to encapsulate essential oils and biocide combinations designed to kill MRSA, has just started at South Manchester University Hospitals Trust in the UK.
In addition to the safety factors usually considered during Phase I trials, this study will also investigate the efficacy of the product on the patients in the trial.
Reports from the UK National Audit Office state that at any one time, 9 per cent of NHS hospital patients are suffering from an infection such as MRSA, acquired whilst in surgery or as an inpatient on the hospital wards. These 'nosocomial' infections affect 100,000 people annually, costing the National Health Service £1 billion (€1.5bn), and causing up to 5,000 deaths.
A spokesman for Micap told In-Pharmatechnologist.com that the trial will involve 40 patients, randomised to receive one of two formulations of the candidate product, which is based on tea tree oil, geranium oil and the widely-used biocide triclosan, or the standard therapy which is triclosan bath.
All the patients will be attending burns clinics and have been diagnosed as having MRSA on their skin, and the primary aim will be the control of MRSA spread, and the reversal of MRSA colonisation.
Use of the three components in combination makes it much harder for MRSA to develop resistance to the treatment, said the spokesman. And formulating it in Micap's yeast cells has a number of benefits. For example, it allows the components to be presented in a dry powder format that stays on the skin and does not evaporate away, increasing the duration that the essential oils and biocide exert their effects.
In addition, it overcomes the fact that essential oils often have a very pungent smell, which could cause problems in terms of patient acceptance.
In vitro studies have already demonstrated the efficacy of the product in controlling numerous strains of MRSA, including epidemic strains that are currently causing major problems in hospitals within the UK and the rest of the world.
The study will be based in the Burns Unit of Wythenshawe Hospital, part of South Manchester University Hospitals Trust under the direction of Ken Dunn, Consultant Burns and Plastic Surgeon, and will be carried out in conjunction with the department of biological sciences at Manchester Metropolitan University.
The spokesman noted that the trial should take six to nine months to complete, and if positive Micap will then seek commercial partners for the technology.
Meanwhile, in addition to the use in treating MRSA colonisation - which would be considered a medical device application by regulators - the technology could also be developed as an environmental contamination method for hospital environments, which could provide a very fast route to market. Initial studies have already been carried out in this setting with positive results, he said.
And ultimately it may be possible to use this or a similar product as a pharmaceutical treatment for colonised/infected patients in hospital and at home, a means of speeding up healing of burns and other wounds. Essential oils have been shown to have tissue-healing properties, said the spokesman.