Multi-centre validation trial for leading products on track for completion by the end of the year including participation from European sites.
Verici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that it has initiated its first European clinical validation trial site with Prof. Gaetano La Manna, Director of the Specialization School in Nephrology and the Dialysis and Transplant Unit, at the Sant'Orsola Polyclinic Hospital in Bologna, Italy.
The trial is a global, non-randomised, observational study for the clinical validation of Verici Dx’s lead products, ClaravaTM to predict risk of early acute rejection in the first six months post-transplant and TutevaTM for the diagnosis of acute cell-mediated rejection, and over the longer term, for the validation of the Company’s fibrosis test, now called Protega™.
Prof. Gaetano La Manna is the Director of the Nephrology, Dialysis and Transplantation Unit at the IRCCS-Sant'Orsola Polyclinic Hospital; he is Director of the School of Specialization in Nephrology of the University of Bologna; Full Professor of Nephrology at the University of Bologna, as well as Deputy Coordinator and member of the Board of Professors of the Research Doctorate in Cardio-Nephro-Thoracic Sciences. Prof. La Manna holds a PhD in Nephrology and Post-Doctorate in Medical Sciences. He has extensive experience in both clinical and experimental nephrology, dialysis and kidney transplantation, and also in the medical management of kidney transplant and its complications. The Kidney Transplant Center of the University of Bologna, inside the IRCCS Sant’Orsola Polyclinic Hospital, is one of the most important in Europe for number, quality and complexity of transplants, with more than 3,000 to its credit, including donation after brainstem death (DBD), donation after circulatory death (DCD), marginal donor, double transplants, ABO incompatible, hyperimmunized patients, combined kidney-liver, kidney-heart transplants and other special programs.
Angela Rose, Senior Director of Clinical Trial Operations of Verici Dx, said:
“The team has worked incredibly hard on this project, from designing and developing the approach to implementing the trial. In our effort to expand our clinical development and validation beyond North America, we are pleased to be working with Prof. Gaetano La Manna, a highly respected and experienced primary investigator, to lead our trial in Bologna, Italy. The diversification of our patient sample is a strategically important initiative for Verici, as we seek to leverage our clinical expertise and demonstrate our commitment to the development of globally validated transplant diagnostics.”
Verici Dx announced the collaboration with three leading US centres for clinical validation trial of its lead products in March 2021 and has subsequently opened 2 more US centres. Enrolment is on target for completion of the Clarava™ and Tuteva™ validation study by the end of 2021. Data is expected to be published as soon as practicably possible in 2022.
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Verici Dx is developing and commercialising tests to understand how a patient will and is responding to organ transplant, with an initial focus on kidney transplants. The body’s own immune system poses a threat to a successful transplant or graft. Patients’ immune systems differ in how they respond to the presence of the transplanted organ, characterising this response is called immune phenotyping. Our products and solutions are underpinned by extensive scientific research into the recipient’s immune phenotype and how that impacts on acute rejection, chronic injury and ultimately failure of the transplant. These immuno-profile signatures also inform clinicians as to the optimal strategy for immunosuppressive and other therapies for the most successful treatment to ensure graft acceptance with the least amount of side effects.
The foundational research was driven by a deep understanding of cell-mediated immunity and is enabled by access to expertly curated collaborative studies in highly informative cohorts in kidney transplant.