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London, UK – 08 May 2013 - Cell Medica today announced the treatment of the first patient in the ASPIRE Trial, an early stage Phase I/II clinical study investigating the safety and efficacy of CytovirTM ADV for the treatment of adenovirus infections in immunosuppressed pediatric patients following bone marrow transplantation.
The ASPIRE Trial represents a collaborative R&D project among Cell Medica, UCL Institute of Child Health and the Great Ormond Street Hospital for Children. The project is funded in part by a grant from the Technology Strategy Board, the UK’s innovation agency.
Cytovir ADV is under development as a new way to treat adenovirus infections in pediatric patients following allogeneic hematopoietic stem cell (bone marrow) transplantation. These patients are profoundly immunosuppressed for a period of three to six months after the procedure and therefore highly vulnerable to serious infections. In certain high risk pediatric groups following bone marrow transplantation, there is a mortality risk of up to 30% for patients developing adenovirus infections. No drug is currently approved for the treatment of adenovirus infections in this patient group.
Cytovir ADV is comprised of naturally occurring T lymphocyte cells (T cells) which demonstrate immune response functions when exposed to adenovirus antigens. The ASPIRE Trial will explore whether adenovirus-specific T cells can be infused in pediatric patients to reconstitute immediate and long-lasting immunity against the virus, thereby potentially avoiding the medical costs, hospitalization and mortality associated with adenovirus infections in this patient group.
The ASPIRE Trial will include up to 15 patients and is expected to complete in early 2015. The Chief Investigator is Dr. Waseem Qasim of the UCL Institute of Child Health.
Extending the pipeline of patient-specific T cell therapies for immune reconstitution
Cytovir ADV is an extension of Cell Medica’s T cell products being investigated for infections in patients following bone marrow transplantation. Cell Medica’s lead product, Cytovir CMV, is currently being tested in two randomized controlled studies across 15 transplantation centres in the UK.
Gregg Sando, CEO of Cell Medica, commented: “The ASPIRE Trial initiates the clinical development of Cytovir ADV in pediatric patients following bone marrow transplantation. Along with Cytovir CMV, we are developing the adenovirus treatment to expand our cell therapy solutions to include two of the most important viral infections in patients following bone marrow transplantation. The clinical research partnership with the UCL Institute of Child Health and the Great Ormond Street Hospital has been very productive in allowing us to identify a high risk group of pediatric patients who could gain particular benefit from an effective and non-toxic antiviral treatment. The support of the Technology Strategy Board was instrumental to provide the platform for this successful collaboration.”
Notes to Editors
About Cell Medica
Cell Medica is a cellular therapeutics company engaged in the development, manufacturing and marketing of T cell immunotherapy approaches for the treatment of infections and cancers related to oncogenic viruses. The Company’s lead cell product, CytovirTM CMV, for the treatment and prevention of cytomegalovirus (CMV) infections in patients following allogeneic bone marrow transplant, is available in the UK and is under development in other territories. Cytovir ADV is being developed for the treatment of adenovirus infections in pediatric patients following bone marrow transplantation. Cell Medica is also working with the Center for Cell and Gene Therapy, Baylor College of Medicine, to develop CytorexTM EBV for the treatment of malignancies associated with the oncogenic Epstein Barr Virus.
About T cell immunotherapy
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 provided early evidence that T cells can be used as a cellular therapeutic for the treatment of viral infections. Certain cancers are also associated with infection by viruses such as the Epstein Barr Virus (EBV). Ongoing clinical research at UCL, Baylor College of Medicine and other institutions is exploring how T cell immunotherapy may be used to eliminate malignant cells which express viral antigens.
About the Technology Strategy Board
The Technology Strategy Board is the UK’s innovation agency. Its goal is to accelerate economic growth by stimulating and supporting business-led 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.
For more information, please contact:
Gregg Sando, CEO
T: +44 (0) 20 7554 4070
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...