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Southampton research has been central to the development and international licensing of one of only two novel asthma therapies in the last 30 years, transforming asthma control and survival for severe allergic asthmatics.
Key studies by the Southampton Group have underpinned the development of immunoglobulin (Ig)-E as a key therapeutic target for controlling allergic asthma, with the Southampton-led first-in- man safety and efficacy trials critical to the registration of the anti-IgE therapy, omalizumab.
This contribution also generated significant inward investment in UK R&D and opened up wider investigation of anti-IgE therapy in a broad range of atopic and inflammatory indications.
Research into novel immunotherapies has given rise to a novel drug (EtxB), which is now in Phase II clinical trials, and to a profitable contract research company partnering with the pharmaceutical industry to develop their compounds. Trident Pharmaceuticals was formed around patents filed by the University of Bristol, has received investment of [text removed for publication], successfully completed Phase I trials (2011) and is in the midst of Phase IIa trials in humans with inflammatory disease (2013). KWS BioTest arose as a result of the underpinning research and experience gained from developing EtxB, and is now a leading contract research organisation working with pharmaceutical and biotechnology companies developing novel treatments for human disease. KWS has directly contributed to the development of therapies at more than 75 different companies, employs 28 people, has exported [text removed for publication] and was 2012 winner of a Biomedical iNet Award for outstanding business achievement.
Chronic, debilitating diseases such as arthritis, chronic obstructive pulmonary disease (COPD) and inflammatory bowel disease (IBD) could potentially be treated by damping down the underlying inflammation and therefore improving the quality of life of sufferers. Nrf2 is a protein that prevents inflammation when activated and many researchers have sought to manipulate its activity as a potential therapeutic strategy. However, this has had little success, due to a lack of suitable biochemical tools. We describe here the Nrf2-activating peptide TAT14, which was developed in Pharmacy and is now being marketed by biotech companies to study this important pathway.
Ongoing research by the University of Southampton has led to significant advances in the understanding of respiratory diseases, for which the dearth of available treatments had health repercussions on a global scale for many years. The formation of a spin-out company, Synairgen, has enabled the discovery and development of new therapeutics, the filing of several major patents in the UK, the US and Asia and external collaborations with industry and government funders. These continuing developments are key to tackling conditions that affect millions of sufferers in the UK alone and which, according to some estimates, cost the NHS £2.6bn every year. The research has given rise to more than £16m in follow-on funding from the NIHR and the MRC for further studies into the treatment of respiratory illnesses.
Research by the University of Southampton has helped transform the understanding and treatment of chronic lymphocytic leukaemia (CLL), the most common leukaemia, affecting around 2,400 patients each year in the UK and 17,000 in the USA. Southampton's widely cited studies revealing the existence of two subsets of CLL have been crucial in giving clinicians and patients in the UK and overseas a much clearer indication of the likely disease course. The predictive information is now included in all clinical trials and in international guidelines, delivering greatly improved care. The research has also inspired the development of a new drug given "breakthrough" status by the Food and Drug Administration in the United States.
Research by the University of Aberdeen has helped deliver a turnaround in the medical advice given to pregnant women in the UK regarding the consumption of peanuts. Previous Department of Health advice was for pregnant women with a personal or family history of allergic disease to avoid eating peanuts in order to prevent allergy in their offspring. However, the Aberdeen research into neonatal immune responses demonstrated that laboratory responses of cord blood mononuclear cells exposed to allergens in vitro were unrelated to antenatal allergen exposure. The findings and resulting change in health advice attracted wide international attention.
Therefore this research has had impact in: health and welfare by changing dietary guidelines, increasing public awareness of a health risk public behaviour and influencing decisions and care practices by a health service.
Research by Professor Parmjit Jat (first at the Ludwig Institute for Cancer Research, then part of UCL; later at the UCL Institute of Neurology) established and applied the critically important scientific concept of conditional immortalisation to a wide variety of cell lines, enabling cells to be grown indefinitely in vitro but differentiate upon altering the growth conditions. Two companies were established in partnership with Jat to exploit this research, ReNeuron (now worth £63.5m and publicly traded on the London AIM market) and XCellSyz (now part of Lonza AG). More than 20 patents based on Professor Jat's work have been issued. Reagents based on his research have been evaluated, licensed and used by 17 companies worldwide: Amgen, Amylin, Boehringer Mannheim, Cell Genesys, Chiron, Eli Lilly, Genentech Inc., Genetics Institute, Immunex, Johnson & Johnson, Medarex, Novartis, Ortho Pharm., Pfizer Inc., Regeneron, ReNeuron, Takeda, EMD Serono, and XCellSyZ/Cambrex Bioscience/Lonza.
Breakthrough structural and mechanistic work at Oxford University investigating how enzymes catalyse oxidising reactions has had major impacts in biomedicinal fields, including how humans adapt to changes in oxygen availability. Impacts arising from the work since 2008 include the identification of new drug targets for major diseases ranging from anaemia to cancer that are being clinically pursued by pharmaceutical companies (including GSK, Bayer, Astellas, Akebia) and smaller companies (including the Oxford spin out ReOx), and the sale of products including small-molecule probes (e.g. by Tocris, Millipore, Selleck Chem) that are of use in biomedicinal/pharmaceutical research, especially in the emerging field of epigenetics.
The discovery of a novel, inhaled dual phosphodiesterase 3 and 4 inhibitor, RPL554 — first developed in the Sackler Institute of Pulmonary Pharmacology, King's College London — led to the creation of a SME, Verona Pharma plc, which then successfully demonstrated clinical benefit in Phase II clinical trials. This is a major breakthrough as a "first in class" drug with both bronchodilator and anti-inflammatory activity in a single medicine for the treatment of important respiratory diseases, asthma and chronic obstructive pulmonary disease.
Psoriasis is a chronic inflammatory skin disorder affecting up to 2.5% of the world's population, approximately 30% of whom eventually develop psoriatic arthritis, which can lead to debilitating long-term health problems. Current therapies are limited owing to side effects or reductions in efficacy. Prof Miles Houslay, University of Glasgow has performed internationally recognised research on drug targets to alleviate the symptoms of inflammatory skin conditions. Working with Celgene, Houslay identified lead compounds and assays to screen promising early compounds for the treatment of psoriasis and psoriatic arthritis for clinical development. This identified the lead compound (apremilast), which was subsequently developed by Celgene. Between 2010 and 2013, phase III trials on apremilast have validated it as a safe, clinically effective oral drug, on the basis of which apremilast was submitted for regulatory approval of its use in patients with psoriatic arthritis to the health authorities of the USA and Canada in March 2013.