Cell Medica announces treatment of first patient in Late Stage Clinical Trial of Adoptive Cell Therapy
London, UK - 10 September 2008: Cell Medica has today announced the treatment of the first patient in its CMV~IMPACT clinical study, a late-stage randomised confirmatory trial aimed at demonstrating the clinical effectiveness of immunoprophylactic adoptive cellular therapy (IMPACT) for the treatment of cytomegalovirus (CMV) infections in immunosuppressed patients.
The trial, funded by the Wellcome Trust through a Translation Award to Cell Medica, is an essential step to establish adoptive cell therapy as routine clinical practice for the treatment of patients at high risk of CMV infection following a bone marrow transplant.
The CMV~IMPACT trial will include 110 patients across eleven UK-based hospitals. The Chief Investigator is Dr. Karl Peggs of the UCL Cancer Institute. The trial will be conducted as a randomised, intention-to-treat study and is expected to be completed within two years.
The trial will focus on preventing CMV infections in patients following an allogeneic haematopoietic stem cell (bone marrow) transplant. These are typically leukaemia or lymphoma patients whose immune systems are profoundly compromised during the period of recovery following a bone marrow transplant. Two methods of adoptive cell therapy using CMV-specific memory T cells will be compared to a control arm receiving only conventional antiviral treatment.
The trial is the first confirmatory study aimed at assessing the comparative efficacy of adoptive cell therapy relative to conventional antiviral drug treatment for CMV infections. Adoptive cell therapy is based upon the infusion of a single dose of CMV-specific T cells to reconstitute immediate and long-lasting immunity against infection, thereby potentially avoiding the medical costs, hospitalisation and harmful side effects associated with repeated antiviral drug treatment.
Building on the success of earlier clinical studies
Early-stage clinical trials conducted independently by members of Cell Medica’s Scientific Advisory Team and including over 40 patients have demonstrated that adoptive cellular therapy can be used to prevent specific infections in patients following bone marrow transplants (see references below). The CMV~IMPACT study will build on these data to determine the level of clinical benefit in a statistically robust manner equivalent to a Phase III trial. The study will also seek to characterise the underlying immunology of the therapeutic effect.
Ted Bianco, Director of Technology Transfer at The Wellcome Trust, said: “We believe that Cell Medica has developed a viable model for the delivery of life-saving cell therapy to patients on a routine basis. In the true spirit of evidence-based medicine, the Wellcome Trust’s funding will not only help the company establish this service, but also to produce authoritative evidence of the therapy’s value through a controlled, randomised trial.”
Gregg Sando, CEO of Cell Medica, commented: “This trial will not only investigate the clinical effectiveness of adoptive cell therapy to treat infectious diseases, but will also allow us to explore the appropriate procedures and logistics required to enable hospitals to use innovative cell therapies based upon an outsourcing provider such as Cell Medica. The fact that we are now treating patients in a confirmatory study shows that this treatment technique is ready for commercialisation. We are pleased to be working with the Wellcome Trust and a number of the leading clinicians and transplant centres in the UK to validate this novel approach to medical treatment.”
Participating Hospitals
The CMV~IMPACT study is being carried out at the following hospitals in the UK, subject to final approvals from local ethics and research committees: Addenbrooke’s Hospital, Beatson West of Scotland Cancer Centre, Birmingham Heartlands Hospital, University Hospitals Bristol, Guy’s Hospital, King’s College Hospital, Royal Free Hospital, The Royal Marsden Hospital, St James's Institute of Oncology, Southampton General Hospital and University College London Hospital.
References
Mackinnon S, Thomson K, Verfuerth S, Peggs K, Lowdell MW. (2008) Adoptive Cellular Therapy for Cytomegalovirus Infection following Allogeneic Stem Cell Transplantation using Virus-Specific T-cells. Blood Cells Mol Dis. 40:63-7.
Cobbold M, Khan N, Pourgheysari B, Tauro S, McDonald D, Osman H, Assenmacher M, Billingham L, Steward C, Crawley C, Olavarria E, Goldman J, Chakraverty R, Mahendra P, Craddock C,. Moss P. (2005) Adoptive transfer of CMV-specific CTL to stem cell transplant patients after selection by HLA-peptide tetramers. J Exp Med 202:379-86.
Peggs KS, Verfuerth S, Pizzey A, Khan N, Guiver M, Moss PA, Mackinnon S. (2003) Adoptive Cellular Therapy for early cytomegalovirus infection after allogeneic stem-cell transplantation with virus-specific T-cell lines. Lancet 362;1375-5
Walter EA, Greenberg PD, Gilbert MJ, Finch RJ, Watanabe KS, Thomas ED, Riddell SR. (1995) Reconstitution of cellular immunity against cytomegalovirus in recipients of allogeneic bone marrow by transfer of T cell clones from the donor. New England Journal of Medicine 333:1038-1044. Leen AM, Myers GD, Sili U, Huls MH, Weiss H, Leung KS, Carrum G, Krance RA, Chang CC, Molldrem JJ, Gee AP, Brenner MK, Heslop HE, Rooney CM, Bollard CM. (2006) Monoculture-derived T lymphocytes specific for multiple viruses expand and produce clinically relevant effects in immunocompromised individuals. Nat Med. 12(10):1160-6.
Notes to Editors:
About Cell Medica
Cell Medica is a clinical cellular therapeutics company engaged in the development and delivery of cellular immunotherapy treatment strategies for infectious disease. The Company’s lead cell therapy targets the prevention of infections in immunosuppressed patients following allogeneic bone marrow transplant. Cell Medica focuses on the commercialisation of cell therapies which have demonstrated clear evidence of safety and efficacy based on Phase I/II clinical trials.
The Company began its research operations in February 2007. With the guidance of its Scientific Advisory Team and funding provided by the Wellcome Trust and Imperial Innovations, the Company has progressed in a short period to the clinical phase of development with respect to its lead cell therapy applications.
About the Wellcome Trust
The Wellcome Trust is the largest charity in the UK. It funds innovative biomedical research, in the UK and internationally, spending around £600 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing. http://www.wellcome.ac.uk
About Imperial Innovations
Imperial Innovations is one of the UK's leading technology transfer and commercialisation companies. The company was founded in 1986 and its ordinary shares admitted to trading on the AIM Market of London Stock Exchange plc in July 2006, raising £25 million at an offer price of 365p and £1 million by means of a public offer. In November 2007, the company raised a further £30 million by means of a placing of new ordinary shares with investors.
The company’s integrated approach encompasses the identification of ideas, protection of intellectual property, development and licensing of technology and formation, incubation and investment in technology businesses. A wide range of technologies are commercialised within the areas of Healthcare, Energy & Environment, Engineering and Software & IT.
As at the close of its last financial year in July 2007, the company – based at Imperial College London – had established equity holdings in 74 technology businesses and was managing 133 commercial agreements. Imperial Innovations also commercialises technologies originating from outside Imperial College through incubation contracts with the Carbon Trust and WRAP and has commercialisation contracts with a number of multinational corporations.
About T cell immunotherapy for the treatment of CMV infection
T cell immunotherapy involves harnessing the power and precision of the human immune system to treat disease. Extensive academic research in the field of clinical immunology has shown that T cells have the ability to recognise and eliminate infections and have the potential to be used in a safe and efficacious manner as an antiviral treatment. Latent infection of cytomegalovirus (CMV) is estimated in over 50% of all humans and is one of the leading causes of sickness and death in immunosuppressed patients, often manifesting as interstitial pneumonia. Adoptive T cell immunotherapy is based on the collection of CMV-specific memory T cells from the same donor providing the bone marrow (and hence closely matched with respect to tissue type) and infusion of these cells in the patient to prevent or treat CMV infections following a bone marrow transplant.
Further more information, please contact:
Gregg Sando
CEO
Cell Medica Limited
Gregg.Sando@cellmedica.co.uk
020 7554 4070
At College Hill
Katja Stout, Holly Griffiths, John McIntyre
020 7866 7856
cellmedica@collegehill.com