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Temozolomide is a major UK anti-cancer drug development success story. Following chemical synthesis at Aston University, early clinical evaluation of temozolomide carried out at Imperial College optimised how temozolomide was scheduled and delivered to patients to ensure maximum efficacy balanced acceptable side effects. Imperial's early trials demonstrated how the drug could be used effectively to treat patients with a type of brain cancer, glioma, and was pivotal to its subsequent market licensing. ESMO and NICE guidelines recommend temozolomide for use in patients with recurrent glioma and for patients with newly diagnosed Grade IV glioma. Glioma is a relatively rare cancer yet annual sales of temozolomide have been in excess of £900 million per year since 2009. Temozolomide given during and following radiotherapy is now standard of care for glioma and has improved survival compared to previous treatments or radiotherapy alone.
Based on clinical studies at Imperial College that radiofrequency energy can seal blood vessels, EMcision Limited was formed. The Company specialises in the research, development and marketing of medical and surgical devices that use RF energy to treat/palliate cancers in organs and tissues. The first product from the Company, the Habib™ 4X, has revolutionised the technique of liver surgery and has generated more than $48 million in sales worldwide. The second most successful product, the Habib™ EndoHPB, generated $1 million in revenue in 2012.
Subcutaneous allergen immunotherapy is highly effective in hayfever sufferers who fail to respond to anti-allergic drugs, but carries the risk of severe allergic side-effects. Professor Durham's group at Imperial College have defined the mechanisms and shown that sublingual tablet immunotherapy is an effective, safer alternative that induces long-term disease remission. The tablet approach is now widespread in Europe and is being successfully extended to other allergies (housedust mite) and internationally (ragweed allergy in USA and Japanese Cedar pollen allergy). The work is quoted in guidelines internationally and regulatory bodies now recognise the disease-modifying potential of immunotherapy and its ability to induce long-term remission.
Dr Dickinson (Bioengineering) collaborated with Professor Habib (Surgery) to develop novel methods for removing or starving tumours. Resection (removing part of an organ) is theoretically an ideal method for treating liver cancer as the liver can regenerate, but it causes extensive blood loss. The Bioengineering team developed a bipolar electrode system that employs RF current to coagulate a track in the liver; the track can then be cut without bleeding. Prototypes were successfully tested in pre-clinical and clinical trials. 20,000 single-use devices (value: US$40M) have been sold under licence by AngioDynamics, with an estimated saving of >800 lives. Complications, intensive care, blood transfusions, and hospital stay have also been dramatically reduced. Dickinson developed further bipolar devices for maintaining the patency of ducts during pancreatic and biliary cancers, for ablating liver tumours and for blocking tumour blood supply. Sold by Imperial spin-out Emcision, these are also in current clinical use.
Aurox Ltd is an Oxfordshire spin-out company formed in 2004 by Prof Mark Neil (at Imperial since August 2002) with former colleagues from Oxford University. Its main product line consists of wide field optical sectioning fluorescence microscopes based on the principle of structured illumination and detection using patterned disks. The microscopes use conventional (lower cost) light sources and do not require a scanning system which sets them apart from competitors. Research at Imperial has impacted on the design of disk patterns for optimising performance and has played a critical role in bringing these microscopes to market. Aurox's systems are supplied to and marketed by Carl Zeiss (as VivaTome™) and Andor Technology (as Revolution DSD™) for application in the biomedical sciences, generating successful sales over the period 2008-2012 and enabling Aurox to embark on a second-generation development programme. Since 2008 Aurox have sold more than 150 units with market value in excess of £3M. The majority of this £3M in sales have been since 2010 when an optimisation step which was developed and devised at Imperial College was incorporated into the Aurox products.
Imperial College preclinical studies guided the desired selectivity profile for long-acting muscarinic receptor antagonists (LAMA). Binding, functional and clinical studies from Imperial laboratories were the first to demonstrate the long duration of tiotropium bromide (Spiriva®) in human tissue, and confirmed its long duration of action in patients and established it as the first-line treatment for chronic obstructive pulmonary disease (COPD). Tiotropium has had a beneficial impact on the management of COPD and is incorporated into the major international treatment guidelines. It improves symptoms, reduces exacerbations and mortality, and provides a cost-effective therapy. Imperial have also produced the first pre-clinical and clinical data for the next LAMA in development (glycopyrrolate, Seebri®), which has recently been marketed. Our profiling of tiotropium has also led to the development of several novel LAMA.
Scientists in the MRC Cyclotron Unit within Imperial College pioneered quantitative Molecular Imaging methods for neuroscience drug development that have since been expanded through collaboration between Imperial and GlaxoSmithKline (GSK) scientists. Human Molecular Imaging has had significant commercial impact with adoption by the major pharmaceutical companies to reduce the risks and costs associated with early drug development. This led directly to the selection of the Imperial Hammersmith Hospital site for the world's first clinical imaging centre embedded in a pharmaceutical company. New GSK investment created new and highly skilled UK employment opportunities first at this GSK Clinical Imaging Centre (CIC) and then Imanova, Ltd., a specialised imaging CRO that was "spun out" from the CIC. Outcomes from studies commissioned by GSK in the CIC and later in Imanova have directly influenced GSK clinical development planning, strategy and drug candidate progression. More recently, outcomes from Imanova are influencing clinical development decisions of other pharmaceutical organisations in similar ways.
Research undertaken within Imperial College showed that corticosteroid resistance in inflammatory diseases, such as chronic obstructive pulmonary disease (COPD) and severe asthma, is explained by reduced histone deacetylase-2 and that reversal of this resistance is possible with theophylline (in low clinical doses) and PI3Kδ inhibitors, which restore HDAC2 function. This led to the founding of a spin-out company RespiVert to develop potent inhaled inhibitors of PI3Kδ. The company has been very successful in finding such new molecules, which have proven to be safe in Phase I studies. RespiVert was acquired by Johnson & Johnson in 2010 and Phase II studies are now in progress in COPD and severe asthma.
Locust and grasshopper outbreaks can form swarms containing billions of insects, creating feared and damaging agricultural pests. Following research at Imperial College London, the entomopathogenic fungus Metarhizium acridum was developed into an oil formulated product (`Green Muscle®') that could be applied by ground-based and aerial spray equipment at ultra-low volume (ULV) rates, when locust and grasshopper populations periodically increased. Green Muscle® has since been used to treat locust outbreaks in Israel and five southern African countries. Green Guard®, an associated mycoinsecticide marketed in Australia, has been used extensively to control locusts in regions where there are land use limitations on chemical pesticides. Both Green Musclef6da and Green Guardf6da are supplied by Becker Underwood. Besides the success of Metarhizium as an effective, environmentally-friendly locust control option, substantial science and enabling technology ensued, that should accelerate the development of other mycopesticides as important alternatives to currently beleaguered chemical pest control methods.
Researchers at Imperial College London have established a spin-out company called Ionscope Ltd which develops and sells Scanning Ion Conductance Microscopes (SICM). This is a novel technology that can (i) characterise live cells and their derivatives non-destructively during differentiation and development, (ii) correlate biophysical features at unprecedented resolution with detailed transcriptional information on a single cell level, and (iii) steer cell fate by mechanical stimulus. Other high magnification techniques interfere with or kill living cells, whereas SICM is benign, allowing living cells to be studied over long periods, making it a highly desirable technology for all groups working within biomedical research. The technique has application in the study of living processes at nano-scale, which to date has included neurons, heart muscle, kidney, sperm and stem cells. Ionscope Ltd sales since 2009 have totalled [text removed for publication], with the company registering a 20% increase in its revenue over the past 5 years.