Biohope, an R&D company dedicated to the development of precision medicine IVD tools for chronic inflammatory conditions, announces the completion of the TRANSBIO clinical study.
The TRANSBIO clinical study has included nearly 200 patients from 9 international hospitals. Data on patients’ clinical and immunological history has been collected as well as a blood sample has been tested with IMMUNOBIOGRAM® (IMBG) to evaluate the expected immune response of the patient when exposed to the most common immunosuppressive drugs (tacrolimus, cyclosporine, azathioprine, mycophenolic acid, prednisone, sirolimus and everolimus).
The study has been performed in collaboration with University Hospital del Mar and University Hospital Vall’d Hebron (Barcelona, Spain); University Hospital “Puerta de Hierro”, University Hospital La Paz and University Hospital 12 de Octubre (Madrid, Spain), the RigsHospitalet (Copenhague, Denmark); the Universitätsklinikum Essen (Germany); the University Hospital Borowska (Wroclaw, Poland) and the Massachusetts General Hospital (Boston, USA).
The conclusions of the TRANSBIO clinical study will be released to the public during the European Congress of Transplantation, Copenhagen 13-14 September 2019. As a summary, results indicate that IMBG is a functional tool for the management of patients who undergone a kidney transplantation in order to personalize the immunosuppressant treatment.
The TRANSBIO clinical study has allowed to confirm the statistically significant correlation between the result of the IMBG and the clinical evolution of the transplanted patient, which means that is a it a promising tool to personalize and better adjust medical treatment in renal transplantation patients.
The signs of graft rejection are significantly associated with more resistance to the drugs tested in the IMBG assay. On the contrary, patients with good clinical outcome are significantly associated with more sensitivity to the drugs they take, confirmed in the IMBG assay. Therefore, we can confirm that the sensitivity or resistance to the immunosuppressant drugs, determined by IMBG assay, is a relevant factor in renal transplantation clinical outcome in terms of rejection.
In addition, the TRANSBIO clinical study have proved the reproducibility of the IMBG test, provided that the result is determined under expert evaluation (clinical immunologist). Nevertheless, we have developed and validated the IMBG analysis software, to standardize the interpretation of the IMBG test results, facilitating the expert review.
The IMBG technology is protected under a granted European product patent, totally owned by Biohope, that have been expanded worldwide through an international patent (PCT).
Biohope expect to launch IMBG to the European market in 2020.