BIOHOPE recently presented the first data of their pilot study “BH-Pilot”, at an investigator meeting with their Scientific Advisory Board held in the context of the European Society of Organ Transplantation (Barcelona, 24-27 September 2017).
The study is being developed in collaboration with the Hospital Puerta de Hierro and La Paz University Hospital, both in Madrid. The main objective of the clinical study is to explore the potential clinical utility of the INMUNOBIOGRAM® in vitro test to adjust immunosuppressive therapy in a personalized way in patients with kidney transplantation.
Immunosuppressive treatment is essential to prevent rejection of the transplanted organ. Usually, the transplanted patients will have to take a combination of medications during all their life to prevent their immune system from attacking the transplanted kidney by not recognizing it as “their own.”
This medication increases the risk of serious health problems such as viral infections or cancer, which occur in a significant proportion of transplanted patients. A better adjustment of the medication, in a personalized way, would allow each patient to receive those medicines that were potentially more effective. This could be of enormous help to select the most appropriate treatment as soon as possible and avoid adverse effects.
The BH-Pilot study included 70 patients from these hospitals, classified into three types depending on the risk of rejection:
• High-risk patients (with a history of rejection, positive antibodies or impaired renal function, or combinations of previous criteria)
• Controlled patients
• Patients at low risk (without risk criteria and low levels of medication for years).
Data on patients’ clinical and immunological history have been collected; an extensive battery of biomarkers has been performed on different platforms to complement the risk information, and 10Ml of blood has been taken to be tested at INMUNOBIOGRAM®.
The results observed to date with the INMUNOBIOGRAM®, obtained in blood samples from 35 kidney transplanted patients and 7 healthy volunteers as a control group, point to a positive proof of concept.
The mosst common drugs were evaluated to establish a resistance/sensitivity profile: tacrolimus, cyclosporine, azathioprine, mycophenolic acid, prednisone, sirolimus and everolimus.
The observed data can be summarized in the following points:
1) The INMUNOBIOGRAM® provides an individualized patient response pattern to immunosuppressive medication.
2) Sensitivity and resistance ranges can be determined for each of the drugs tested.
3) Significantly associated resistance patterns have been detected in proportion to the doses used and the clinical evolution of the patient, so that patients who present worse clinical evolution and also receive higher doses of medication, have higher resistance rates.
In the following graphic, it is observed that in 60% of high-risk patients, there is resistance to some drugs of the battery tested, according to the INMUNOBIOGRAM®. Such resistance is shown in at least one drug of those taking.
The following graphic shows the relation between the dose of drug taken from the patient (low-low, intermediate-media, high-high) and the mycophenolic acid inhibitory capacity on the activity and proliferation of cells of the immune system.
The greater the inhibition, the more potential efficacy of the drug. It is observed that lower doses achieve higher levels of inhibition in the two measures performed (area over the curve – AOC and inhibitory dose 50 – ID50) compared to the high doses.
Data from the complete cohort of included patients are expected to be available by 1Q2018.