Publication of ASPIRE Clinical Trial Results

August 1, 2018

Cell Medica Announces Publication of ASPIRE Clinical Trial Results

All Patients Cleared Adenovirus Infection Following Cytovir ADV™ Treatment

The results of the phase 1/2 ASPIRE study of adenovirus-specific T cells (Cytovir ADV) in pediatric patients after allogeneic hematopoietic stem cell transplantation (HSCT) have been published (Ip et al, Cytotherapy, 2018; 20:830-38). In the ASPIRE study, high risk pediatric patients who had undergone allogeneic HSCT, and with evidence of systemic adenovirus infection were treated with adenovirus specific T cells (Cytovir ADV) made from the transplant donor. All patients had previously received standard antiviral treatment with limited effect. Manufacturing success rate was 93%. Eight patients were treated, and all resolved adenovirus viremia between 15 and 127 days after Cytovir ADV infusion. Adenovirus specific T cells were detectable in all analysed patients after infusion based on immunospot assay. Serious adverse events included grade 2 graft versus host disease, astrovirus encephalitis and pancreatitis. This study demonstrated the feasibility and safety of Cytovir ADV for high risk pediatric patients after transplantation and provides early evidence of clinical efficacy.

Professor Waseem Qasim, the Chief Investigator on the study and Consultant in Paediatric Immunology at Great Ormond Street Hospital commented that “Transplant patients with adenovirus infection who do not respond to standard antiviral therapy can have high mortality rates and are very difficult to treat; this study contributed to the feasibility and safety data for adenovirus specific T cells in these patients. It is very encouraging that the patients cleared virus, which should lead to better clinical outcomes. Additional studies will be required to confirm efficacy and establish the optimal place in therapy for Cytovir ADV “

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