Cell Medica 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.
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.”