CAMBRIDGE, England, July 29, 2014 /PRNewswire/ --
PlaqueTec has developed and patented the Liquid Biopsy System (LBS) for collecting biological data associated with heart disease directly from the coronary arteries. The LBS takes multiple blood samples concurrently from different locations within the coronary artery of patients and looks for elevations in biological activity in diseased segments. The LBS has the potential to drive the discovery and development of new drugs and therapeutics, as well as being able to evaluate the efficacy of both approved drugs and agents in development.
PlaqueTec is delighted to confirm CE certification of its LBS which opens up a series of pioneering research and industry collaborative clinical studies with leading cardiovascular clinicians. The first study will be run at Papworth Hospital Cambridge, one of the leading UK centres for the treatment of cardiovascular disease.
Cardiovascular disease accounts for 29% of deaths globally and is predicted to remain the single leading cause of death through to 2030, yet the value, pipeline and predicted success of new products to treat the condition are falling. This is partly because of the lack of knowledge of what is actually taking place in the diseased coronary artery; the large and escalating costs associated with patient trials of drugs that were developed within the context of that knowledge vacuum; and the consequent decreasing number of new drugs gaining regulatory approval for general use.
To assist in the development of improved therapies, product developers have focused on physical measurements of the heart and its arteries to measure disease progression and to predict clinical effects. It is now established that biological information, for instance changes in the biomarkers within the coronary arteries, will offer a clearer way of measuring disease and treatment. To date, such information has been very difficult to obtain quickly, reliably, safely or, indeed, at all.
PlaqueTec has worked over the last 5 years with leading clinicians, engineers, and academics to develop its LBS. The LBS can be used alongside standard equipment in a catheterisation laboratory and allows a clinician to obtain multiple blood samples, in a highly controlled manner, directly from the site of disease in a coronary artery. During the initial safety studies with the device, PlaqueTec and its Papworth collaborators observed local elevations in biomarkers within diseased coronary arteries. These biomarkers could not have been detected using traditional peripheral blood sampling. This raises the likelihood of pharmaceutical industry researchers, in collaboration with PlaqueTec, being able to identify new targets for treatment, and also detect whether certain interventions, whether drug or device, have a positive effect on coronary artery disease, and thus on long term patient health.
Dr Richard Owen, PlaqueTec’s Chief Scientific Officer said; "We believe that there is a real need for such a system. There have been multiple late stage cardiovascular product failures in recent times, costing the pharmaceutical industry hundreds of millions of dollars. Any system that can provide insight into the process of heart disease and the effects of developmental treatments, can create new discovery opportunities, and also rationalise drug pipelines by providing guidance on which products are more likely to demonstrate clinical efficacy. Such guidance could be given prior to 9-figure drug trials being initiated."
Dr Nick West, who led the First In Man clinical trial at Papworth Hospital and is Principal Investigator for the first study post CE mark, points out that "Being able to get quality, standardised biological information from the primary site of interest for atherosclerosis and thrombosis, is a major step forward, moving beyond existing systems based on imaging and physical measurements. With the CE mark achieved, PlaqueTec can now expand its clinical programme of collaborations." PlaqueTec is now in discussions with various Pharmaceuticals manufacturers regarding a number of different LBS studies.
The potential value of the technology was confirmed by Prof Gregg Stone, Professor of Medicine at Columbia University and Co-Director of Medical Research and Education at the Cardiovascular Research Foundation, New York, who commented: "The potential to sample biomarkers produced locally from vulnerable plaque offers great promise to identify lesions and patients at risk for thrombosis with subsequent heart attack and death."
PlaqueTec as a company is now poised for growth - building partnerships with pharmaceutical and device companies directly involved in cardiovascular disease product discovery and development. Prof Martin Rothman, Chief Medical Officer for Medtronic and Professor of Interventional Cardiology at Bart's Health, London concluded: "PlaqueTec is at an exciting and critical time following its achievement of CE mark. There is a real need from both clinicians and the Pharmaceutical industry to better understand the complex interplay of biological signalling that exists during disease progression. Scientists need to be able to better identify patients who are at most risk of fatal atherothrombotic events and better differentiate new and existing therapies."
PlaqueTec was formed in 2008 as a spin out from the innovation centre of PA Consulting, Melbourn, Cambridge. With funding from IPEX Capital, the company invested in designing and engineering the Liquid Biopsy System to take biological samples from the diseased coronary artery. PlaqueTec has a strong network of leading scientific advisors and clinicians and, in particular, works in close partnership with Papworth Hospital where the company is located.
Contact: Richard Owen,
Chief Scientific Officer
SOURCE PlaqueTec Ltd