Date: 15 October 2012

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.

ENDS

For more press information, please contact The London Clinic Press Office on 0207535 5507 or email pressoffice@thelondonclinic.co.uk

Notes to Editors:

The London Clinic

  • The Advanced Therapies Centre offers patients the latest advances in treatments whilst adhering to the strict UK legislation regulating the safe use of unlicensed medication for clinical trials or Named Patient Programs. Information including regulations changes collection, risk assessment and guidelines for use with regular reporting and monitoring
  • The London Clinic is the UK’s largest independently-owned non-profit hospital
  • Over 250 patient beds and 12 operating theatres including dedicated endoscopy suites and a day surgery unit
  • 24 hour consultant-led Intensive Care Unit with 11 beds
  • As a registered charity and not-for-profit organisation, The London Clinic is able to continuously reinvest in the latest medical technology, facilities and clinical and nursing support
  • Highly complex procedures in addition to routine surgery and medicine such as organ transplants, radiosurgery, radiotherapy, robotic surgery and neurosurgery
  • Located on Harley Street in the heart of London’s medical community
  • Long-standing international reputation attracting leading consultants for over 80 years
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