A new cancer treatment which strengthens a patient's immune system and enables them to fight the disease more effectively is being trialled on patients for the first time in the UK.
The treatment will use a new DNA vaccine, developed by scientists from the University of Southampton, which will treat a selected group of volunteers who have either chronic or acute myeloid leukaemia - two forms of bone marrow and blood cancer.
Scientists believe they can control the disease by vaccinating patients against a cancer-associated gene (Wilm's Tumour gene 1), found 'expressed' in almost all chronic and acute leukaemias.
A team of researchers and health practitioners, led by Professor Christian Ottensmeier of the University of Southampton Experimental Cancer Medicine Centre and Dr Katy Rezvani of Imperial College London and Imperial College Healthcare NHS Trust, hope to recruit up to 180 patients to the trial which will take place at hospitals in Southampton, London and Exeter over the next two years.
The research is funded by the charity Leukaemia & Lymphoma Research and the Efficacy and Mechanism Evaluation (EME) programme, which is financed by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR).
"In chronic myeloid leukaemia, current treatment can reduce the cancer but the drug needs to be taken indefinitely and has unpleasant side effects. Prognosis of acute myeloid leukaemia is currently poor and better treatments are urgently needed," comments Christian Ottensmeier, professor of experimental cancer medicine at the University of Southampton and consultant oncologist at Southampton University Hospitals NHS Trust.
"We have already demonstrated that this new type of DNA vaccine is safe and can successfully activate the immune systems in patients with cancer of the prostate, bowel and lung. We believe it will prove to be beneficial to patients with acute and chronic myeloid leukaemia."
Dr Katy Rezvani, clinical senior lecturer at Imperial College London and consultant haematologist at Imperial College Healthcare, says: "At Hammersmith Hospital we have been using targeted leukaemia drug therapies, like tyrosine kinase inhibitors, for over 10 years. While these drugs are the first line therapy for chronic myeloid leukaemia patients, they can rarely 'cure' the condition. This new vaccine has the potential to improve the outcome of leukaemia treatments and could serve as a method of managing solid tumours."
Professor Freda Stevenson, an immunologist at the University of Southampton who is also working on the study, adds: "I'm very pleased with the results from the laboratory research, and am optimistic the vaccine will be successful in making a real difference to patients with myeloid leukaemia."
In the study, each participant will receive six doses of DNA vaccine over a six month period, with further booster vaccinations if successful. The vaccine will be administered in a groundbreaking new way, using electroporation, in which controlled, rapid electrical pulses create permeability in cell membranes and enable increased uptake of biological material after its injection into muscle or skin tissue. The electroporation system was developed by the US pharmaceutical company Inovio.
Inovio's CEO Dr J Joseph Kim, says: "This study expands Inovio's long-standing relationship with the University of Southampton into an important disease area. We are proud that Inovio will make a significant contribution to this Phase II trial for these cancers with clear unmet medical needs."
The DNA vaccine was developed at the University with funding from Leukaemia & Lymphoma Research and Cancer Research UK.
Dr David Grant, Scientific Director of Leukaemia & Lymphoma Research, adds: "We are delighted to see this trial in leukaemia go ahead. It is an important step for us to see the laboratory work on DNA vaccines that the charity has supported take the next logical step into clinical testing. The trial has undergone extensive international peer review and we are very excited to see the first patients being treated. We believe that this vaccine has real promise to improve outcomes in patients with leukaemia."
The success of the vaccines will be measured over a two year survival period for acute myeloid leukaemia and by assessing the immune system's response to the drug using a disease marker (BCR-ABL) for chronic myeloid leukaemia.
Study centres
Southampton University Hospitals NHS Trust - Southampton General Hospital - www.suht.nhs.uk
Imperial College Healthcare NHS Trust - Hammersmith Hospital - www.imperial.nhs.uk/hammersmith
Royal Devon and Exeter NHS Foundation Trust - Royal Devon and Exeter Hospital - www.rdehospital.nhs.uk/
About Leukaemia
Leukaemia is a malignant disease of the bone marrow and blood characterised by the uncontrolled accumulation of blood cells. Leukaemia accounts for 220,000 deaths worldwide each year.
Acute myeloid leukaemia (AML) is a cancer of the myeloid line in blood cells and is characterised by rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. Chronic myeloid leukaemia (CML) is a type of cancer that causes the body to produce large numbers of immature and mature white blood cells.
Notes to Editors:
1. For further information contact:
Sophie Docker , Media Relations, University of Southampton, Tel: 023 8059 8933, email: S.Docker@soton.ac.uk
Henry Winter, Media Relations, Leukaemia & Lymphoma Research, Tel: 020 7269 9019, email: HWinter@beatbloodcancers.org
2. The Phase II study is called: "WT1 immunity via DNA fusion gene vaccination in haematological malignancies by intramuscular injection followed by intramuscular electroporation."
3. Leukaemia & Lymphoma Research is the only UK charity solely dedicated to research into blood cancers, including leukaemia, lymphoma and myeloma. These cancers are diagnosed in around 28,500 children, teenagers and adults in the UK every year. As we receive no government funding and rely entirely on voluntary support, we need to raise £120 million in the next five years to continue this life-saving research. www.llresearch.org.uk/ www.beatbloodcancers.org
4. Inovio is developing a new generation of vaccines, called DNA vaccines, to treat and prevent cancers and infectious diseases. Its SynCon™ vaccines are designed to provide broad cross-strain protection against known as well as newly emergent strains of pathogens. These vaccines, in combination with Inovio's proprietary electroporation delivery devices, have been shown to be safe and increase immune responses to targeted antigens 100-fold. Inovio's clinical programs include cervical dysplasia and cancer (therapeutic), avian flu (preventive), and HIV vaccines (preventive and therapeutic). www.inovio.com.
5. The University of Southampton is a leading UK teaching and research institution with a global reputation for leading-edge research and scholarship across a wide range of subjects in engineering, science, social sciences, health and humanities. With over 22,000 students, around 5000 staff, and an annual turnover well in excess of £400 million, the University of Southampton is acknowledged as one of the country's top institutions for engineering, computer science and medicine. www.soton.ac.uk
6. Imperial College Healthcare NHS Trust comprises Charing Cross, Hammersmith Hospital, Queen Charlotte's & Chelsea, St Mary's and Western Eye hospitals. It is one of the largest Trusts in the country, and in partnership with Imperial College London, is the UK's first Academic Health Science Centre (AHSC). The AHSC was created to take the research discoveries it makes and translate them into new and improved treatments and techniques to directly benefit patients throughout the Trust and beyond.
7. Imperial College London: Consistently rated amongst the world's best universities, Imperial College London is a science-based institution with a reputation for excellence in teaching and research that attracts 14,000 students and 6,000 staff of the highest international quality. Innovative research at the College explores the interface between science, medicine, engineering and business, delivering practical solutions that improve quality of life and the environment - underpinned by a dynamic enterprise culture.
8. Cancer Research UK is the world's leading cancer charity dedicated to saving lives through research. The charity's groundbreaking work into the prevention, diagnosis and treatment of cancer has helped save millions of lives. This work is funded entirely by the public. Cancer Research UK has been at the heart of the progress that has already seen survival rates double in the last forty years. Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses. Together with its partners and supporters, Cancer Research UK's vision is to beat cancer.
9.The Efficacy and Mechanism Evaluation programme supports later-phase "science-driven" clinical trials and evaluative studies, which seek to determine whether a health intervention (e.g. a drug, diagnostic technique or device) works and in some cases how or why it works. The Efficacy and Mechanism Evaluation programme (www.eme.ac.uk ) is funded by the Medical Research Council and managed by the National Institute for Health Research.
10. The NIHR provides the framework through which the research staff and research infrastructure of the NHS in England is positioned, maintained and managed as a national research facility. The NIHR provides the NHS with the support and infrastructure it needs to conduct first-class research funded by the Government and its partners alongside high-quality patient care, education and training. Its aim is to support outstanding individuals (both leaders and collaborators), working in world class facilities (both NHS and university), conducting leading edge research focused on the needs of patients. www.nihr.ac.uk
11.The Medical Research Council is dedicated to improving human health through excellent science. It invests on behalf of the UK taxpayer. Its work ranges from molecular level science to public health research, carried out in universities, hospitals and a network of its own units and institutes. The MRC liaises with the Health Departments, the National Health Service and industry to take account of the public's needs. The results have led to some of the most significant discoveries in medical science and benefited the health and wealth of millions of people in the UK and around the world. www.mrc.ac.uk
12. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the MRC, NHS, NIHR or the Department of Health.
Sophie Docker , Media Relations, University of Southampton, Tel: 023 8059 8933, email: S.Docker@soton.ac.uk
Henry Winter, Media Relations, Leukaemia & Lymphoma Research, Tel: 020 7269 9019, email: HWinter@beatbloodcancers.org