UK Leads Europe In Gene Therapy Trials (press release)

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Latest gene therapy trials focus on Cancer, HIV and Coronary Heart Disease -

Details of eleven gene therapy trials approved by the Gene Therapy Advisory Committee (GTAC) will be published today (3 April 2005) at GTAC's annual public meeting in Manchester.

Information on the trials, published today in GTAC's Eleventh Annual Report covering 2004, show the majority of the approved gene therapy trials focus on cancer. Trials have been approved for colorectal cancer, prostate cancer, leukaemia, brain cancers, breast cancer and advanced tumours. This continues the trend of over 70% of all applications to GTAC having a focus on cancer. Of the other applications, one is an approach to combat HIV infection and three are for coronary heart disease.

The report highlights the UK's leading position on gene therapy trials in Europe, and also includes summaries of the completed gene therapy trials and an analysis of all the 96 UK trials carried out to date.

Health Minister, Lord Warner said:

"I am delighted to announce the publication of GTAC's Eleventh Annual Report and congratulate the committee on its good work. The UK leads Europe in this field with 40% of European gene therapy clinical trials being carried out in the UK.

Gene therapy has the potential to improve the lives of thousands of patients. The government is committed to ensuring that the UK remains at the forefront of innovative medical research and has provided the funding towards new gene therapy clinical trials for inherited diseases such as Duchenne Muscular Dystrophy, cystic fibrosis and childhood blindness. These trials are likely to be considered by GTAC in 2005/6."

The GTAC public meeting is taking place at Manchester University on Sunday 3rd April. Over 100 scientists, students, parents, genetic counsellors, charity representatives and health care professionals are expected to attend. The aim of the meeting is to raise public awareness of gene therapy.

1. GTAC is the national specialist ethics committee for gene therapy research. All UK gene therapy trials need approval from GTAC. GTAC assesses patient safety and continually keeps developments in the field under review.

2. Gene therapy is a new, innovative treatment which holds great promise for treating many common diseases, such as cancer and heart disease, as well as offering hope to those with inherited conditions such as Duchenne muscular dystrophy. Many inherited diseases are the result of a missing or damaged gene. Gene therapy involves the deliberate introduction of genetic material into human cells for therapeutic, preventative or diagnostic purposes. Rather than trying to treat the symptoms, gene therapy aims to correct the underlying problem by introducing healthy copies of these genes, or other beneficial genetic material into patient's cells. 3. The gene therapy trials approved in 2004 include:

HIV - A study to test a gene therapy product that stimulates the body's infection fighting cells (T lymphocytes) to help combat HIV soon after exposure.

Brain cancers - Two advanced studies that may develop treatments for brain cancers. In one study a gene is introduced that causes the cancer cells to produce an enzyme which means they give off a signal enabling them to be targeted for destruction using existing drugs. In other study, a modified virus is used which targets and kills cancer cells but leaves normal brain tissue undamaged.

Cardiovascular disease - All three studies use genes introduced to stimulate the formation of new blood vessels in the heart or limbs.

More details are available in the annual report which will be published on 3rd April. For an embargoed media copy of the report please contact Claire Rich on 020 7210 5238 or out of hours please call 07050 073 581.

4. GTAC's public meeting starts at 10.30am on 3 April at Hulme Hall, Oxford Place, Victoria Park, Manchester University. It is part of the annual meeting of the British Society of Gene Therapy which is on 4-5 April. GTAC's public meeting includes the following presentations:

Demystifying gene therapy clinical trials by Dr Christian Ottensmeier, Cancer Research UK/Southampton University

Developing a gene therapy product by Dr John Ellis, Oncology project leader at ML Laboratories plc

Research Ethical Issues by Dr Tuija Takala and Dr Lisa Bortolotti, Centre for Social Ethics and Policy, Manchester University

Process of informed consent by Deborah Beirne, gene therapy nurse at St James' Hospital Leeds

Role of Charities by Dr Glenn Pierce, World Federation of Haemophilia

Patients and the public by Renee Watson, British Society for Gene Therapy

5. GTAC's membership is drawn from a wide range of medical, scientific, legal and lay expertise. Further information on GTAC, reports of its meetings and publications can be found at advisorybodies.doh.gov.uk/genetics/gtac

6. Since approving the first gene therapy trial in the UK in 1993, GTAC has approved 96 gene therapy clinical trials, involving almost 900 patients. These gene therapy studies target inherited disorders, infectious diseases such as HIV infection, and cardiovascular disease. The majority (71%) of trials are for the treatment of cancer, including breast, ovarian, cervical, pancreatic, prostate, bladder, head & neck, blood, colorectal and liver cancer as well as skin cancer.

7. For media queries please contact Claire Rich on 020 7210 5238 or Ben Lewis on 020 7210 4990.

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