BICYPAPA : Ergebnisse der TLX250 Bridging Studie
Interim Analysis of 89Zr-TLX250-CDx Bridging Study (?ZIR-DOSE?) Demonstrates Significantly Improved Patient Dosimetry Melbourne (Australia) 15 October 2018. Telix Pharmaceuticals Limited (ASX.TLX) (?Telix?, the ?Company?), a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or ?molecularly-targeted radiation? (MTR), today announced that it has completed an interim analysis of the ZIR-DOSE dosimetry bridging study, conducted as part of Phase III readiness for 89Zr-TLX250-CDx imaging in metastatic renal (kidney) cancer. The ZIR-DOSE study is a 10 patient Pk / multi-time point imaging study designed to compare the whole-body dosimetry of 89Zr-girentuximab (TLX250-CDx) with historical dosimetry data for 124I-girentuximab (Wilex AG / Heidelberg Pharma). As part of the commercial development of TLX250-CDx, Telix elected to change the isotope from 124I to 89Zr in order to lower patient dose, enhance image contrast, lower cost of goods and improve clinical workflow by eliminating the need for thyroid blocking. The ZIR-DOSE study achieves both a mass dose comparison between 5mg and 10mg injected dose, as well as full body dosimetry. An interim analysis was conducted by ABX CRO (Dresden, Germany) on the first 5 patients, covering both 5 and 10mg mass dose.
The key findings are: ? A 10mg mass dose was confirmed as superior with a 50% reduction of liver dose and 25% less intestinal dose, compared with 5mg. ? The absorbed dose from 37 MBq (1mCi) of 89Zr-girentuximab is 18 mSv/mCi, approximately 25% less than that of 124I-girentuximab (24 mSv/mCi) ? validating that the change of isotope results in a meaningfully lower patient radiation dose. ? The dosimetry observed for 89Zr-girentuximab (TLX250-CDx) is well within legislated radiation safety limits in any regulatory jurisdiction. Telix CEO Dr. Christian Behrenbruch stated, ?This interim data enables us to proceed with first patients in our global multi-centre Phase III trial for TLX250-CDx with the confidence that we have the dosing and dosimetry right, with much improved image quality compared with iodinated girentuximab. Although this is a small study in terms of number of subjects, radiation dosimetry studies are especially demanding on patients and we are grateful to those who have volunteered to participate in the clinical trial, as well as our excellent clinical collaborators at Radboud University Medical Centre (RUMC) in the Netherlands.?