Clinical Research
Cytovir ADV
Cytovir ADV is a cell therapy medicinal product designed to provide a patient with protective immunity to control adenovirus infection post-transplant. Children are particularly susceptible to these infections after bone marrow transplant.
Adenoviruses (ADV) are a group of viruses that infect the membranes of the respiratory tract, intestines, eyes and urinary tract. This virus rarely causes complications in healthy individuals but following bone marrow transplant, infection is associated with a high level of mortality and morbidity. Approximately 80% of the human population carries an adenovirus latent infection.
Cell Medica and UCL Institute of Child Health (Great Ormond Street Hospital) are planning the Phase I/II ASPIRE (Adenovirus-Specific Paediatric Immune REconstitution) clinical trial to progress the clinical development of Cytovir ADV for the treatment of adenovirus infections in paediatric patients following a stem cell transplant. This project will be co-funded by the Technology Strategy Board. ADV infections cause mortality in up to 30% in high risk populations of paediatric patients post-transplant and current antiviral drug therapies are of limited benefit as, at present, there is no specific antiviral drug which is approved for adenovirus infections in paediatric patients. The aim of the planned trial is to demonstrate the safety and efficacy of Cytovir ADV in this setting. This innovative cell therapy addresses an important unmet medical need and a successful trial will ensure the continued development towards regulatory approval.
As a first-in-man test of Cytovir ADV, the ASPIRE trial will be a single arm, phase I/II safety study in 15-20 high risk paediatric stem cell (bone marrow) transplant recipients. All patients will be monitored for evidence of ADV in the blood and treated with Cidofovir in the event of viraemia. Cytovir ADV will be administered as a single dose if two consecutive blood tests detect the presence of virus. An independent Data and Safety Monitoring Committee will evaluate all adverse events including GvHD and will have authority to halt the study if unacceptable toxicity (as defined by the Committee’s charter) becomes apparent. Reduction of viraemia to non-significant levels will be viewed as an efficacy indicator. The therapeutic agent is a population of adenovirus-specific effector T cells selected from the original stem cell transplant donor and expanded with synthetic adenovirus-specific peptides and cytokines in-vitro prior to isolation, concentration and intravenous infusion.
