Tom3 schreef op 5 mei 2021 10:52:
The last program for which we expect to have a clinical readout in the near term is ARO-HIF2, which is designed to inhibit the production of HIF-2a to treat clear cell renal cell carcinoma or RCC. We are currently conducting a Phase 1b dose-finding clinical study in three cohorts with advanced clear cell RCC. The study is designed to evaluate the safety of ARO-HIF2, to determine the recommended Phase 2 dose, and to assess pharmacokinetics and preliminary efficacy, based on RECIST, and post-dose tumoral expression of HIF2-alpha and HIF associated genes.
We have completed dosing in two of the three cohorts and should be able to report on those two cohorts in the coming two months. We made a protocol amendment last quarter to add patients to the study. These are heavily pretreated patients with metastatic lesions in different locations, so biopsy collection is challenging. The new patients were added to give us a better chance of having tumor samples that can be processed, evaluated, and analyzed. We will be looking for data suggesting functional delivery to tumors as well as measurable levels of HIF2 knockdown.
Kennelijk bestonden de bestaande deelnemers aan de trial uit de wat meer recht-uit recht-aan nierkanker patiënten. Als je nu een cohort toevoegt dat nog zieker is (gezien waargenomen uitzaaiingen) dan zou het kunnen zijn dat de resultaten bij de eerdere cohorten niet teleurstellend zijn.