It is a sobering fact that eight out of twenty of us will be diagnosed with cancer during our lives, and for five out of twenty of us it will lead to our deaths. This is the statistical background to a largely unmet need for the relief of suffering and a market opportunity estimated to exceed £60 billion.
Current cancer treatments are largely based on surgery, chemotherapy or radiotherapy. Whilst these responses can be effective for some cancers, they have a range of unsatisfactory features. These include unpleasant side effects, limited effectiveness and no protection against recurrence of the disease.
More recently there has been a growing interest in immunotherapy, which attempts to harness some aspect of the patient’s own immune system to combat the cancer. Therapies based on monoclonal antibodies are rapidly establishing themselves. Herceptin (in late stage breast cancer) has annual sales of $957 million (2004). Similarly, Avastin (in late stage colorectal cancer) has sales of $555 million in its first year on the market (2004).
Monoclonal antibody treatments are not, however, vaccines. They utilise part of the immunological system to interfere with cancer cell growth or carry toxic agents to the cancer cells. They do not “switch on” the body’s natural immune response to the cancer in the manner of a true vaccination.
An effective vaccination-based treatment for cancer would have a number of important advantages over chemotherapy and radiotherapy. It could be specific for tumours (not damaging non-tumorous tissue), offer long-term immunity against recurrence and avoid unpleasant side effects. Most importantly, it would offer the opportunity for a vastly more successful treatment, with real cures for patients whose death from cancer is currently merely postponed for a few weeks or months.
There is good early evidence for the potential of this strategy. Clinical data from vaccines cultured from patients’ own cells have been shown to generate the appropriate response, although they would be very costly to produce and difficult to approve within the current regulatory environment. A vaccine from Portland, Oregon which uses a primitive form of the CVL-patented approach has been shown to be safe in Phase I clinical trials and also stimulates the appropriate immune response. There is additional supporting animal research data from various independent groups in the US, Italy and Switzerland.
The CVL approach has been reviewed and validated by respected authorities in the field, including leading cancer clinicians such as Prof Will Steward, the Head of Clinical Oncology at Leicester Royal Infirmary. It has also been subjected to independent scientific due diligence scrutiny by Dr Adrian Robins, Reader in Immunology at the University of Nottingham and co-ordinator or the British Society for Immunology’s Tumour Immunology Affinity Group.