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Case Studies

A number of case studies are provided which help demonstrate the synergy and successful relationship between academia, industry and healthcare.

Case Study 1 – Provexis plc – A Liverpool success story

Provexis plc entered Liverpool’s MerseyBIO Incubator in 2003 with seed investment, and after only two years became a publicly traded company on the London Stock Exchange, with a current market capitalisation of £40 million. This is a life science business that discovers, develops and licenses scientifically proven functional food, medical food and dietary supplement technologies.

Provexis established laboratory-based operations in MerseyBIO in order to develop its first product, Fruitflow®. This is a proprietary extract of tomato with anti-thrombotic properties, helping to prevent heart attack and stroke by inhibiting blood platelet aggregation. It has been developed through clinical trials, which have substantiated health claims, through manufacturing processes and commercial product marketing. The company is now in advanced licensing discussions with global companies for incorporating Fruitflow® into yoghurts, beverages and other products. Fruitflow® is the first (and only) technology to have a health claim adopted by the European Food Safety Authority.

The company has other innovative technologies. As part of the support that Provexis has received in MerseyBIO, the company was introduced to innovators in the Liverpool health sciences community, including Professor Jon Rhodes, consultant gastroenterologist at the Royal. Provexis worked with Professor Rhodes on the commercial potential of a plantain extract to be used as a medical food for the dietary management of Crohn’s disease. This is now undergoing a clinical trial funded by the Liverpool Biomedical Research Centre in Microbial Disease to establish its effectiveness in keeping the disease in remission. The company is also looking its potential applications in preventing and treating infections with the ‘super bug’ C. difficile.

Provexis plc is a Liverpool success story – an innovative life sciences company that has been incubated in Liverpool, growing in scope and value, and in partnership with the research and health care communities in the city.

Case Study 2 – Therapeutic Drug Monitoring for HIV drugs

The Problem

HIV treatment is expensive (costing the NHS in excess of £200 million per year). Antiretroviral therapy is lifelong and despite its proven success, is still associated with an appreciable rate of virological failure (10-20% / year). HIV drugs are amongst the most “therapeutically risky” licence for use in man, with considerable potential for drug interactions which impact on drug exposure.

Despite its proven efficacy, HIV treatment is relatively “unforgiving” and requires high levels of adherence to treatment lifelong. Early studies suggested that adherent levels of < 95% were associated with a high risk of virological failure, or even worse, drug resistance.

Following a standard dose of drug, the variability between different people in drug concentrations achieved in the blood is huge for all HIV drugs. Many factors influence this, including body weight, drug interactions, age of the patient and genetic factors impacting on metabolic function. As such, the same dose of drug may yield excessively high concentrations in one person, and yet levels which are insufficient to act on HIV in another. There is no obvious way of identifying such patients, but clearly the principle of “one dose fits all” cannot apply to HIV therapy.

The Solution

Using LC-mass spectrometry, we developed and validated a high-throughput, highly sensitive assays for measuring a comprehensive range of HIV drugs. A thorough literature search was undertaken to produce a systematic analysis of the available evidence for determining targets for efficacy and toxicity for each HIV drug for which there were available data.

In 1999, we rolled out therapeutic drug monitoring (TDM) service for HIV drugs, initially piloted in North West England. In 2003, TDM became incorporated into standard of care in the British HIV Association guidelines. By this time, TDM also became incorporated into routine clinical care in France, Germany, The Netherlands and subsequently Italy and Spain.

In 2005, the TDM service was achieving an annual turnover in excess of £400,000 and was spun into Delphic Diagnostics Limited (an individualised HIV diagnostic SME) with the University of Liverpool taking a stake in the company. The diagnostic laboratory was housed in the University’s Bioincubator (MerseyBIO).

Delphic continued to operate and expand the service to include more drug assays (with the continued help of University academics), pharmacogenetic testing and virological resistance testing until December 2009, when the service was taken over by Lab 21 plc.

Professor S H Khoo, MD, MRCP, DTM&H
Department of Pharmacology & Therapeutics
University of Liverpool

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