14 DAY TRIAL // Southampton researchers and health practitioners will test, for the first time in the UK, a new cancer treatment which strengthens the patients' immune system and enables them to fight the disease more effectively.
The team is led by Professor Christian Ottensmeier of the University of Southampton Experimental Cancer Medicine Center and Dr Katy Rezvani of Imperial College London and Imperial College Healthcare NHS Trust, and they hope to engage 180 patients in their trial, taking place at hospitals in Southampton, London and Exeter, over the next two years.
The treatment is based on a new DNA vaccine, developed by University of Southampton scientists, which will be administered to a group of volunteers, with either chronic or acute myeloid leukemia (two forms of bone marrow and blood cancer).
The idea is to control the disease by vaccinating patients against a gene associated with cancer – Wilm's Tumour gene 1, which is ‘expressed’ in almost all chronic and acute leukemias.
Christian Ottensmeier, professor of experimental cancer medicine at the University of Southampton and consultant oncologist at Southampton University Hospitals NHS Trust, explains that “in chronic myeloid leukemia, current treatment can reduce the cancer but the drug needs to be taken indefinitely and has unpleasant side effects.
“Prognosis of acute myeloid leukemia is currently poor and better treatments are urgently needed," comments.
“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 leukemia.”
Every study participant will receive six doses of DNA vaccine over a six-month period, followed by booster vaccinations if the strategy is successful.
The way of administrating the vaccine is also a new one, since it uses electroporation; this means that controlled, rapid electrical pulses will help create permeability in cell membranes, thus enabling an increased uptake of biological material after its injection into muscle or skin tissue.
“At Hammersmith Hospital we have been using targeted leukemia drug therapies, like tyrosine kinase inhibitors, for over 10 years,” says Dr Katy Rezvani, clinical senior lecturer at Imperial College London and consultant hematologist at Imperial College Healthcare.
“While these drugs are the first line therapy for chronic myeloid leukemia patients, they can rarely ‘cure’ the condition.
“This new vaccine has the potential to improve the outcome of leukemia treatments and could serve as a method of managing solid tumors.”
“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 leukemia,” adds Professor Freda Stevenson, an immunologist at the University of Southampton also working on the study.
The DNA vaccine was developed at the University with funding from Leukemia & Lymphoma Research and Cancer Research UK, and the electroporation system was developed by the US pharmaceutical company Inovio.
A two-year survival period for acute myeloid leukemia and an evaluation of the immune system's response to the drug, through a disease marker (BCR-ABL), will determine the success of the vaccines.
This research is funded by the charity Leukemia & Lymphoma Research and the Efficacy and Mechanism Evaluation (EME) program – financed by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR).