Date: 2013-05-08
Type of information: Initiation of preclinical development
phase: 1-2
Announcement: treatment of first pediatric patient
Company: Cell Medica (UK)
Product: Cytovir™ ADV
Action
mechanism: Cytovir™ ADV is comprised of naturally occurring T lymphocyte cells (T cells) which demonstrate immune response functions when exposed to adenovirus antigens. 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.
Disease: adenovirus infections in immunosuppressed pediatric patients following bone marrow transplantation.
Therapeutic area: Infectious diseases - Transplantation
Country: UK
Trial
details: 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.
Latest
news: * On May 8, 2013, Cell Medica has 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 Cytovir™ 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.
