London, UK, 10 January 2012 : Cell Medica, a leading UK cellular therapeutics company that develops, manufactures and provides cellular immunotherapy products for the treatment of infectious disease and cancer, has received notice of grant funding from the Technology Strategy Board for a Phase I/II clinical trial - ASPIRE (Adenovirus-Specific Paediatric Immune Reconstitution) in collaboration with the UCL Institute of Child Health / Great Ormond Street Hospital for Children NHS Trust. The study is designed to demonstrate the safety and efficacy of Cytovir ADV - Cell Medica’s adoptive cellular therapy for the treatment of adenovirus infections in paediatric patients following bone marrow transplant (allogeneic haematopoietic stem cell transplant or allo-HSCT).
Adenovirus infections cause mortality in up to 30% of children in high risk patient populations following allo-HSCT and current antiviral drug therapies are of limited benefit. Adoptive cellular therapy has already shown promising results in preventing viral disease in patients receiving a bone marrow transplant 1, 2.
Cell Medica will be study sponsor and will prepare their adenovirus specific T cell therapy products (Cytovir ADV) for patients being treated. Dr Waseem Qasim and Prof Bobby Gaspar of the UCL Institute of Child Health / Great Ormond Street Hospital for Children NHS Trust are the study investigators.
Gregg Sando, CEO of Cell Medica, commented: “We are delighted to have support from the Technology Strategy Board for this study as the first-in-man Phase I/II clinical study of Cytovir ADV. The potentially life-saving, patient-specific cell product will be manufactured using our proprietary rapid expansion system which we believe represents the state of the art for the production of cultured therapeutic T cell products. We are also very pleased to be collaborating in this project with Europe’s leading centre devoted to research in children’s health; Great Ormond Street Hospital for Children and UCL Institute of Child Health. The ASPIRE Trial takes us closer to regulatory approval and commercial availability of Cytovir ADV for the treatment of life-threatening infections in children undergoing bone marrow transplant.”
1. Safe adoptive transfer of virus-specific T-cell immunity for the treatment of systemic adenovirus infection after allogeneic stem cell transplantation. Feuchtinger T, Matthes-Martin S, Richard C, Lion T, Fuhrer M, Hamprecht K, Handgretinger R, Peters C, Schuster FR, Beck R, Schumm M, Lotfi R, Jahn G, Lang P.
2. Combined CD8+ and CD4+ adenovirus hexon-specific T cells associated with viral clearance after stem cell transplantation as treatment for adenovirus infection. Zandvliet ML, Falkenburg JH, van Liempt E, Veltrop-Duits LA, Lankester AC, Kalpoe JS, Kester MG, van der Steen DM, van Tol MJ, Willemze R, Guchelaar HJ, Schilham MW, Meij P.
Cell Medica currently sponsors two clinical studies to investigate the use of adoptive cellular therapy to prevent and treat cytomegalovirus (CMV) infection following allo-HSCT – CMV~IMPACT (ImmunoProphylactic Adoptive Cellular Therapy Study – CI Dr Karl Peggs) which is funded through a Translation Award by the Wellcome Trust; and CMV~ACE/ASPECT (Cytomegalovirus ~ Alternate Donor Study of Pre-Emptive Cellular Therapy – CI Dr Karl Peggs) which is funded, in part, by a grant to the University of Birmingham from Leukaemia Lymphoma Research.
About T cell immunotherapy for the treatment of adenovirus 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. Adenoviruses are a group of viruses that infect the membranes of the respiratory tract, intestines, eyes and urinary tract. They account for approximately 10% of acute respiratory tract infections in infants. While infection rarely causes complications in healthy individuals, following allo-HSCT, infection is associated with a high level of mortality and morbidity. Adoptive T cell immunotherapy is based on the administration of adenovirus-specific memory T cells from the fully or partially matched donor providing the bone marrow and infusion of these cells to provide protective immunity to control adenovirus infection post-transplant.
About the Technology Strategy Board
The Technology Strategy Board is a business-led government body which works to create economic growth by ensuring that the UK is a global leader in innovation. Sponsored by the Department for Business, Innovation and Skills (BIS), the Technology Strategy Board brings together business, research and the public sector, supporting and accelerating the development of innovative products and services to meet market needs, tackle major societal challenges and help build the future economy. For more information please visit www.innovateuk.org
The funding award follows successful application to the ‘Developing Therapeutics’ competition for research and development funding within the Regenerative Medicine Programme. The challenge of the Developing Therapeutics competition was to enable the preclinical and clinical development of previously identified therapeutic candidates (that can replace or regenerate human cells, tissues or organs to restore or establish normal function) to create regenerative products.
Iain Gray, Chief Executive of the Technology Strategy Board, said: “The UK is a world leader in regenerative medicine, with a strong academic science base and a supportive clinical and regulatory environment. For UK businesses to fulfil their potential in this field, gaining a commercially competitive edge and exploiting promising discoveries, a number of development challenges need to be overcome. This is why we launched the Regenerative Medicine Programme, to underpin and enable the best regenerative medicine businesses in the UK and build a connected regenerative medicine community.”
About Cell Medica
Cell Medica is a clinical cellular therapeutics company engaged in the development, manufacture and marketing of cellular immunotherapy treatments for infectious disease and cancer. The company’s lead cell therapies, Cytovir, target the prevention of infections in immunosuppressed patients following allogeneic bone marrow transplant. Certain cancers are also targeted through the Company’s antigen-specific T cell approach.
For further information please visit www.cellmedica.co.uk or contact:
Gregg Sando, CEO, Cell Medica Limited
+44 (0)20 7554 4070