Girentuximab

First US Patients Dosed in Phase III ZIRCON Trial of Renal Cancer Imaging Product

Retrieved on: 
Sunday, January 24, 2021
Kidney cancer, Medical physics, Medical specialties, Medicine, Clinical medicine, Renal cell carcinoma, Clear cell renal cell carcinoma, Kidney tumour, Medical imaging, Girentuximab, Positron emission tomography

MELBOURNE, Australia and INDIANAPOLIS, Jan. 24, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patients have been dosed in the Phase III ZIRCON1 clinical trial of Telixs renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in the United States.

Key Points: 
  • MELBOURNE, Australia and INDIANAPOLIS, Jan. 24, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patients have been dosed in the Phase III ZIRCON1 clinical trial of Telixs renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in the United States.
  • The objective of the ZIRCON trial is to evaluate the sensitivity and specificity of PET/CT imaging with TLX250-CDx to non-invasively detect clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses in comparison with surgical resection (histology), as the standard of truth.
  • The remaining seven U.S. sites2 and three sites3 in Canada are expected to commence patient recruitment progressively over the next month.
  • ZIRCON is a prospective imaging trial in approximately 250 renal cancer patients undergoing kidney surgery, to 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.

First Patients Dosed in Phase III ZIRCON Trial of Renal Cancer Imaging Product in Turkey

Retrieved on: 
Thursday, October 22, 2020
Physical sciences, Medicine, Chemistry, Girentuximab, Renal cell carcinoma, Radiopharmaceutical, Zirconium, Zircon, Medical imaging, Kidney cancer

MELBOURNE, Australia and ISTANBUL, Turkey, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) and Eczacba-Monrol Nuclear Products Co. (Eczacba Monrol) are pleased to announce that the first patients have been dosed in Telixs Phase III ZIRCON clinical trial of Telixs renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in Turkey.

Key Points: 
  • MELBOURNE, Australia and ISTANBUL, Turkey, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) and Eczacba-Monrol Nuclear Products Co. (Eczacba Monrol) are pleased to announce that the first patients have been dosed in Telixs Phase III ZIRCON clinical trial of Telixs renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in Turkey.
  • ZIRCON (Zirconium Imaging in Renal Cancer Oncology) is an international multi-centre Phase III study at 33 sites in Europe, Australia, Turkey, Canada and the United States (subject to regulatory approval in the various jurisdictions).
  • ZIRCON is a prospective imaging trial in approximately 250 renal cancer patients undergoing kidney surgery, to 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 Limited both as a diagnostic PET imaging agent, 89Zr-Girentuximab (Phase III) and a therapeutic radiopharmaceutical, 177Lu-Girentuximab (Phase II).

First Patient Dosed in Phase I/II Trial of Renal Cancer Imaging Product in Japan

Retrieved on: 
Tuesday, August 18, 2020
Chemistry, Physical sciences, Minerals, Refractory materials, Monoclonal antibodies, Clinical research, Drug discovery, Pharmaceutical industry, Zirconium, Girentuximab, Clinical trial, Zircon

TOKYO, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Japan K.K., a wholly-owned subsidiary of Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) is pleased to announce that the first patient has been dosed in a Phase I/II study of Telixs renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in Japan.

Key Points: 
  • TOKYO, Aug. 18, 2020 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Japan K.K., a wholly-owned subsidiary of Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) is pleased to announce that the first patient has been dosed in a Phase I/II study of Telixs renal cancer diagnostic imaging product TLX250-CDx (89Zr-girentuximab) in Japan.
  • The patient population for the ZIRDAC-JP trial has been selected to be identical to the global Phase III ZIRCON trial, with comparison to surgical resection (histology) as standard of truth.
  • President, Dr. Shintaro Nishimura stated, The ZIRDAC-JP study is the first commercially sponsored clinical trial in Japan in which a zirconium-based diagnostic agent has been studied.
  • ZIRDAC-JP (Zirconium Dosing and Comparison in Japan, NCT04496089) is a Japanese multi-centre Phase I/II study that will recruit approximately 40 patients in total.

Harbour BioMed Receives U.S. FDA IND Approval for Phase 2 Clinical Trial and Orphan Drug Designation for Anti-PD-L1 Monoclonal Antibody, HBM9167

Retrieved on: 
Thursday, February 27, 2020
Oncology, Health, FDA, Clinical trials, Pharmaceutical, Biotechnology, Life sciences, Biotechnology, Articles, Monoclonal antibodies, Cancer immunotherapy, Biopharmaceutical, Girentuximab, Sacituzumab govitecan

Harbour BioMed (HBM) today announced U.S. Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application for a Phase 2 clinical trial of HBM9167, its humanized IgG1 monoclonal antibody targeting programmed death-ligand 1 (PD-L1), for the treatment of nasopharyngeal cancer (NPC).

Key Points: 
  • Harbour BioMed (HBM) today announced U.S. Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application for a Phase 2 clinical trial of HBM9167, its humanized IgG1 monoclonal antibody targeting programmed death-ligand 1 (PD-L1), for the treatment of nasopharyngeal cancer (NPC).
  • Separately, the Agencys Office of Orphan Products Development granted HBM9167 Orphan Drug Designation (ODD) for the use in treating NPC.
  • The Orphan Drug Designation for HBM9167 will provide an accelerated development path for HBM9167.
  • Harbour BioMed is a global, clinical stage biopharmaceutical company developing innovative therapeutics in the fields of immuno-oncology and inflammatory diseases.