The Medicines and Healthcare products Regulatory Agency (MHRA) has approved in record time, the initiation of a Phase II clinical trial to investigate the potential of CyberKnife induced tumour damage, in combination with an immune system stimulant from skin injections in treating advanced metastatic colorectal cancer. This is to be undertaken at The London Clinic’s new Advanced Therapies Centre.
The new immunotherapy IMM-101 (an immunotherapeutic agent containing Heat-killed Mycobacterium obuense), which has been developed by Immodulon, is an exciting and revolutionary concept in cancer treatment. It consists of both an immunomodulator (to direct the immune response in the right way to a cancer) and an immunoadjuvant (to enhance the immune response). Trial investigators believe that, when used in conjunction with CyberKnife® Robotic Radiosurgery System – a very accurate form of radiotherapy for patients who have inoperable or complex tumours – the immunotherapy will significantly improve patient quality of life. The CyberKnife in this case, is not being used to destroy the tumour, simply damage it in order to release dead tumour cells to direct an immune response, and it is believed the immunotherapy will significantly enhance this.
Dr Andrew Gaya, Consultant Clinical Oncologist at The London Clinic and lead trial investigator, says “This trial will potentially provide colorectal cancer patients who have no other standard treatment option with a means of increased quality of life. The new vaccine has indeed been trialled in the areas of melanoma and pancreatic cancer, and shown promising results, and we hope that it will also stabilise colorectal tumours. Side effects are generally few and the treatment is really well tolerated and has minimal impact on the patient’s life.”
Trial investigators are currently in the process of recruiting for the initial phase of 12 patients, for who treatment is financed by The London Clinic and charitable donations. If a response is seen in the trial, which is termed ‘translational’ (meaning it can be adapted as it progresses), the trial will be further extended.
Alistair Gifford-Moore, Clinical Trials Manager at The London Clinic Advanced Therapies Centre, says “The trial has been approved by National Research Ethics committee, The London Clinic Ethics Committee and Research Governance as well as the MHRA. The establishment of the new Advanced Therapies Centre, which is one of the first clinical trials programme in the independent healthcare sector, has allowed us to provide this innovative treatment options to patients on trial at The London Clinic. The clinical trials program provides consultants more treatment options to critically ill patients.”
Clinical trials are vital for improving the care of those with cancer. The London Clinic is able to utilise its cutting edge equipment and world leading expertise in order to provide patients with access to novel therapies and the best possible care options. The initiation of this latest trial further cements The London Clinic’s commitment to clinical investigations and, as part of a wider research programme, it also supports the Clinic’s charitable status by contributing to the scientific foundation of future clinical treatment and management of patients in the UK.