CASE STUDIES

The ASPIRE Project - Adenovirus-Specific Paediatric Immune Reconstitution 27th Mar 2013

Adenovirus (ADV) infections cause mortality in up to 30% of high risk populations of paediatric patients following allogeneic haematopoietic stem cell (bone marrow) transplant (allo-HSCT). No antiviral drug is approved for this indication and an effective treatment for this patient group represents a critical unmet clinical need.

The ASPIRE Project - Adenovirus-Specific Paediatric Immune Reconstitution

The technology

Cytovir ADV™ is a cell therapy with the clear potential to address this need and to demonstrate the unique advantages which cell therapy can deliver over existing drugs. Cytovir ADV™ comprises adenovirus-specific T-cells which expand in the presence of viral antigen to ‘reconstitute’ the immunity to infection in an immunocompromised transplant recipient.

Cell Medica and ICH-UCL Institute of Child Health have launched the ASPIRE (Adenovirus-Specific Paediatric Immune REconstitution) Phase I/II Clinical Trial to progress the clinical development of Cytovir ADV™ for the treatment of paediatric allo HSCT patients as part of a plan to achieve accelerated regulatory approval for this life-saving therapy.

The aims

The Technology Strategy Board (TSB) has previously awarded two grants to Cell Medica as part of the “Developing Therapeutics” research funding programme. The first allowed investigation of feasibility and optimisation of cell expansion methodies and the second supported the initial collaboration with ICH (Great Ormond Street Children’s Hospital). This latter award enabled the retrospective review of 300 paediatric transplant recipients to identify the group at highest risk of ADV reactivation. This analysis provided vital information for the design of the PhaseI/II ASPIRE study.

The TSB has awarded a third grant which supports the launch and execution of the ASPIRE Clinical Trial. The study has now started and the first cell products have been manufactured. This trial represents a first-in-man study of adenovirus specific T-cells (Cytovir ADV™) which will assess the safety and efficacy of the cell therapy given to paediatric transplant recipients who reactivate the virus. A review of the current status of the study will be given at a future date.

The Team

Karen Hodgkin, Head of Clinical Development, Cell Medica Ltd
 

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