Heidelberg Pharma AG (Seite 523)
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Dann nenne mir doch bitte mal Aktien, die sich derzeit dem schlechten Marktumfeld entziehen können?!
Bist ab sofort auf Ignore. Heute schon der 3. hier 🙄
Kann ich auch leider gar nicht lesen, welche Aktien das sein sollen, also bemühe dich 🐒 erst gar nicht 😄
Bist ab sofort auf Ignore. Heute schon der 3. hier 🙄
Kann ich auch leider gar nicht lesen, welche Aktien das sein sollen, also bemühe dich 🐒 erst gar nicht 😄
Antwort auf Beitrag Nr.: 58.978.911 von versuchsprimat am 17.10.18 09:39:45
Der Beweis
Die Kursentwicklung der letzten Tage beweist, dass es tatsächlich nur eine technische Erholung gab.
Antwort auf Beitrag Nr.: 59.009.826 von BICYPAPA am 20.10.18 10:34:11
(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.
About TLX250
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.
Start Phase 3 Redectane TLX250
Telix Commences ZIRCON Phase III Renal Cancer Imaging Trial Melbourne (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.
About TLX250
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.
Empfehlung EQUI-Reports, Analyst Thomas J. Schießle
Die Crux am Ende:"Offenlegung von möglichen Interessenskonflikten:
Mögliche Interessenskonflikte können Sie auf der Seite des Erstellers/ derQuelle der Analyse einsehen."
Empfehlung EQUI-Reports, Analyst Thomas J. Schießle
Die Crux am Ende:"Offenlegung von möglichen Interessenskonflikten:
Mögliche Interessenkonflikte können Sie auf der Seite des Erstellers/ der Quelle der Analyse einsehen"
Antwort auf Beitrag Nr.: 58.957.842 von BICYPAPA am 15.10.18 07:32:34
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.
Author information
Abstract
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.
RESULTS:
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.
CONCLUSION:
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.
Redectane-Girentuximab_TLX250
Sehr wahrscheinlich wird die Ph3 Studie von Telix nun bald starten. Doch neben der Veröffentlichung von Telix TLX250 evtl bei Darmkrebsformen zu nutzen gibt es nun auch Hinweise Girentuximab noch in weiteren Indikationen anwenden zu können. Ich poste mal das Abstract hierzu. Das ist wahrscheinlich noch sehr langfristig. Doch es soll auch nur die Möglichkeiten von Girentuximab aufzeigen.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.
Author information
Abstract
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.
RESULTS:
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.
CONCLUSION:
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.
Antwort auf Beitrag Nr.: 58.987.908 von BICYPAPA am 18.10.18 04:56:44
Heidelberg Pharma: GMP-Produktion von Krebswirkstoff etabliert - Aktienanalyse
http://www.aktiencheck.de/exklusiv/Artikel-Heidelberg_Pharma…
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Heidelberg Pharma: GMP-Produktion von Krebswirkstoff etabliert - Aktienanalyse
http://www.aktiencheck.de/exklusiv/Artikel-Heidelberg_Pharma…
Das Abwarten der Anleger
Schmidt-Brand am 26.03. im Interview 4Investors: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.
Antwort auf Beitrag Nr.: 58.977.369 von BICYPAPA am 17.10.18 05:15:12
Heidelberg Pharma is a drug development company, which provides pre-clinical drug discovery and development services for the development of anti-cancer and anti-inflammatory drugs to pharmaceutical and biotechnology industries.
https://www.proactiveinvestors.com/companies/stocktube/10893…
Präsentation at the Bio Investor Forum
Heidelberg Pharma AG (ETR:WL6) CEO Jan Schmidt-Brand spoke with Christine Corrado at the Bio Investor Forum in San Francisco.Heidelberg Pharma is a drug development company, which provides pre-clinical drug discovery and development services for the development of anti-cancer and anti-inflammatory drugs to pharmaceutical and biotechnology industries.
https://www.proactiveinvestors.com/companies/stocktube/10893…
Oder zu Höchstkursen von 2011 bei 20 Euro eingestiegen...?!
Da hilft nur nachkaufen & EK senken, Versuchsprimat! 🙈😉
Da hilft nur nachkaufen & EK senken, Versuchsprimat! 🙈😉
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