Heidelberg Pharma AG
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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.”
BICYPAPA: Telix Partnerschaft mit Cyclotec
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 an extension to its master service agreement (MSA) with Cyclotek (Aust) Pty Ltd (“Cyclotek”) to include 89Zr-girentuximab (TLX250-CDx) for imaging patients with clear cell renal cell cancer (ccRCC) using Positron Emission Tomography (PET).
Telix has selected Cyclotek to manufacture and supply Australian clinical trial sites as well as serve as a part of Telix’s global production network as a backup site for the Company’s global multi-centre Phase III clinical trial. This extension of the MSA leverages Cyclotek’s extensive expertise in production scale-up of novel PET tracers and its leadership position in the Australian and New Zealand radiopharmaceutical manufacturing landscape. In addition to supporting clinical trials, the manufacturing partnership paves the way for the provision of TLX250-CDx to the regional market.
Telix CEO Dr Christian Behrenbruch stated, “The extension of our agreement with Cyclotek delivers another important component in Telix’s network for supply of TLX250 for our clinical trials and also creates a platform for commercialization of the product in the future. We value our partnership with Cyclotek for their experience in GMP manufacturing and their demonstrated ability to deliver highquality product as an integrated part of international trials.”
Cyclotek Clinical Director Dr Rob Ware commented, “We are delighted to expand our relationship with Telix to assist with their objective of including several excellent Australian clinical trial sites in their roadmap to establish the clinical effectiveness of 89Zr-girentuximab for the imaging of metastatic kidney cancer. This development aligns with our core belief in the potential of molecularly targeted radiation (MTR) to improve healthcare outcomes for cancer patients, both diagnostically and therapeutically.”
BICYPAPA: Nach der TLX250 Bridging Studie
Eckdaten HP erhält ca 30% für die Bilddiagnostik von ca 70 Millionen$ bei Zulassung und zusätzliche Milestones von etwas über 3 Millionen Euro. Ab 2021 könnten sie damit nach der Zulassung nur für die Bilddiagnostik mit etwa 20 Millionen$ rechnen.
Mit der Therapeutik plant Telix Phase 2b Studien und wenn alles klappt wäre hier mit Zulassungen etwa 2023 zu rechen. Die Umsatzbeteilgung beträgt hier für HP etwa 5% von ca gut 400 Millionen $ Also noch mal etwa 20 Millionen $.
Es sind noch Indikationserweiteung seitens Telix mit TLX250 geplant. Doch das wäre sehr langfristig und ist alles noch in Anfangsplanungen
Die Einzelheiten könnt ihr der folgenden prima Analyse entnehmen.
BICYPAPA: Telix Redectane
Melbourne (Australia) and Nijmegen (the Netherlands) – 17 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 concluded a GMP manufacturing agreement with Radboud Translational Medicine B.V. (“RTM”).
Telix has been working with RTM under a technology transfer and research agreement for the past six months, during which time RTM and Telix have completed process development and production optimization. The parties are now completing validation runs with the objective of providing patient doses for European trial sites by approximately end-October 2018. Additionally, RTM will serve as a backup production site to Telix’s partner production sites in North America (Isologic) and Australia (Cyclotek).
Telix EU President Odile Jaume stated, “RTM has been a core part of taking the 89Zr-girentuximab process development out of Radboud University Medical Centre (RUMC) and industrializing the radiochemistry for Telix’s Phase III study. The RTM facility is state-of-the-art, backed by a very capable team and we are pleased to be working with them for our clinical trials and eventual commercial production of the product.”
RTM General Manager, Dr Lars Perk commented, “RUMC was a pioneer in the use of girentuximab for imaging and therapy and so it has been a pleasure to work with our university colleagues to bring this very promising technology out of academia and into a commercial production environment. As RTM continues to build its production capabilities, we welcome the opportunity to partner with innovative companies like Telix to bring new radiopharmaceuticals to market.”
versuchsprimat: Kursplus gestern und heute
versuchsprimat: Das Abwarten der Anleger
Wir haben unsere Investor Relations-Arbeit wieder intensiviert und halten den Kontakt zu internationalen institutionellen Investoren, die an den Fortschritten unserer Technologie interessiert sind. Wir wissen, dass es viel Arbeit und Geduld bedarf, um gerade in den USA langfristige Investoren zu gewinnen. Aber wir sind sehr optimistisch, dass wir mit guten klinischen Daten unserer innovativen Technologie neue Investoren an Bord holen können.
Preclinical validation of 111In-girentuximab-F(ab')2 as a tracer to image hypoxia related marker CAIX expression in head and neck cancer xenografts.
Huizing FJ1, Hoeben BAW2, Franssen G3, Lok J2, Heskamp S3, Oosterwijk E4, Boerman OC3, Bussink J2.
BACKGROUND AND PURPOSE:
Hypoxia is a major cause of radio- and chemoresistance. Carbonic anhydrase IX (CAIX) is an endogenous hypoxia-related marker and an important prognostic marker. Assessment of CAIX expression may allow patient selection for hypoxia or CAIX-targeted treatment. The radioactive tracer 111In-girentuximab-F(ab')2 targets CAIX and can be used for SPECT imaging. Aim of this study was to validate and optimize 111In-girentuximab-F(ab')2 for imaging of CAIX expression in head and neck tumor xenografts.
MATERIAL AND METHODS:
Affinity and internalization kinetics of 111In-girentuximab-F(ab')2 were determined in vitro using CAIX-expressing SK-RC-52 cells. Tumor targeting characteristics were determined in athymic mice with six different head and neck squamous cell carcinoma (SCCNij) xenografts. Tracer uptake was measured by ex vivo radioactivity counting. Intratumoral distribution of tracer uptake was measured using autoradiography and CAIX expression was determined immunohistochemically.
26% of the tracer was internalized into the SK-RC-52 cells within 24h. The half maximal inhibitory concentration (IC50) was 0.69±0.08nM. In biodistribution studies SCCNij153 tumors showed the highest tracer uptake: 4.1±0.8ID/g at 24h p.i. Immunohistochemical and autoradiographic analyses of the xenografts showed a distinct spatial correlation between localization of the tracer and CAIX expression.
111In-girentuximab-F(ab')2 has a high affinity for CAIX. In vivo tumor uptake correlated strongly with CAIX expression in different head and neck xenografts. These results suggest that 111In-girentuximab-F(ab')2 is a promising tracer for imaging of hypoxia-related CAIX expression.D
versuchsprimat: Empfehlung EQUIReports, Analyse Thomas J. Schießle
Die Crux am Ende:
"Offenlegung von möglichen Interessenskonflikten:
Mögliche Interessenskonflikte können Sie auf der Seite des Erstellers/ der Quelle der Analyse einsehen."
Er schreibt immer negativ :-(
BICYPAPA: Studienstart Phase 3 Redectane TLX250
(Australia) – 23 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 “molecularlytargeted radiation” (“MTR”) has today announced that the Company is preparing to commence recruitment for its ZIRCON Phase III trial for imaging of clear cell renal cell cancer (ccRCC) with 89Zr-girentuximab (TLX250).
Concurrent with ongoing submissions to regulatory authorities and clinical sites in Europe, Telix has successfully completed a Clinical Trial Notification (CTN) submission to the Therapeutic Goods Administration (TGA) and has now received its first Human Research Ethics Committee (HREC) approval in Australia. The Company is planning to recruit patients at a total of four clinical sites in Australia.
Telix CEO Dr. Christian Behrenbruch stated, “As an Australian-headquartered company, it’s very pleasing to be able to start to recruit patients in our own backyard while we finalize the regulatory documentation in the various international jurisdictions. Our EU submissions are progressing well with several key review milestones in November that should enable us to bring further international sites online before end-year. In all the countries we plan to run the ZIRCON study, there has been a high level of clinician enagement and we expect this trial to recruit well.”
About the ZIRCON Study
ZIRCON (“Zirconium Imaging in Renal Cancer Oncology, EudraCT 2018-002773-21) is a global multi-centre Phase III study with at least 15 sites in Europe, Australia and the United States, subject to regulator approval in the various jurisdictions. ZIRCON is a prospective imaging trial in approximately 250 renal cancer patients undergoing kidney surgery, and will determine the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic “ground truth” determined from surgical resection specimens.
TLX250 (girentuximab) is being developed by Telix Pharmaceuticals both as a therapeutic drug (177Lu-girentuximab, in Phase II) and a diagnostic PET imaging agent, denoted as TLX250-CDx (“Companion Diagnostic”). TLX250 is an antibody-based platform that targets carbonic anhydrase IX (CAIX), a cell surface target that is over-expressed in several serious cancers, including renal, lung, colorectal and esophageal cancer. High CAIX tumour expression is generally correlated with poor prognosis. Telix has prioritized the development of TLX250 for metastatic renal cell cancer (RCC), particularly the clear cell variant (ccRCC), which almost ubiquitously over-expresses CAIX.
About the Renal Cancer Imaging Market
The opportunity for advanced renal cancer imaging techniques consists of several distinct clinical needs, ranging from patients that have had an incidental finding in the kidney, to diagnosed patients undergoing staging (or re-staging) and for treatment response assessment.
Kidney cancer patients are commonly mis-staged as metastases may be very small and do not typically image well using conventional techniques. Between the US and EU5 there are about 120,000 new diagnoses a year (Globocan), where more precise diagnostic imaging tools would significantly impact patient care. In the US alone the prevalence of clear cell renal cell cancer (ccRCC) is approxiately 450,000 patients (SEER), a large proportion of which would benefit from better imaging for staging and treatment response.
versuchsprimat: @versuchsprimat 17.10. - Der Beweis
versuchsprimat: @gaston866 22.10.
versuchsprimat: @gaston866 17.05.
versuchsprimat: P.S.: (15.09 Uhr)
versuchsprimat: Nur Quatsch, lieber gaston866
BICYPAPA: Ich möchte euch bitten
versuchsprimat: Fakten, Fakten, Fakten!
Nehmen wir den 15. Januar diesen Jahres:
DAX 13.200 - Kurs HDP 3,90
DAX 11.200 - Kurs 2,10
Während der DAX nur 15 Prozent verloren hat, liegt der Verlust von HDP bei 47 Prozent!
Niemand sollte sich deshalb von Schönrednern für dumm verkaufen lassen!!!
Nero.: HP wann kommt die Wende ?
Kann sein das der gesamt Markt nach Süden geht aber das ist nicht Grund das HP so viel an Wert verloren hat.
Vllt kommen noch gute news ...hoffe ich mal
BICYPAPA: Ein Update zu den ..