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ProstACT SELECT Study of TLX591 Interim Readout: Positive Results Confirm Safety and Tolerability

The study has achieved its primary objectives, confirming the safety and tolerability profile of TLX591 administered in two doses, two weeks apart in combination with standard of care (SoC) Preliminary activity demonstrates meaningfulPSA[1] reduction; monitoring of patients is ongoing, including for rPFS[2] Findings reinforce the potential advantages of this first-in-class radio-antibody drug conjugate (rADC) investigational therapy, consistent with previous clinical studies of TLX591[3] MELBOURNE, Australia, Oct. 19, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces positive preliminary results from the Phase I ProstACT SELECT study of its rADC therapy candidate TLX591 (Lutetium (177Lu) rosopatamab tetraxetan) for prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC). The purpose of the SELECT study (ClinicalTrials.gov ID: NCT04786847)was to evaluate the utility of PSMA imaging to select

Telix to Showcase New ZIRCON Phase III Kidney Cancer Imaging Data and Theranostic Pipeline at EANM

MELBOURNE, Australia, Sept. 6, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces presentations featuring the Company's theranostic programs at the 36th Annual Congress of the European Association of Nuclear Medicine (EANM) to be held in Vienna from 9 - 13 September 2023. Further data from Telix's completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118) will be presented in on oral session on Sunday 10 September. In addition, the congress program features the following Telix initiatives: Sponsored symposium on personalised diagnostics in urological cancers: the promise of nuclear medicine; Phase III ProstACT GLOBAL study of TLX591 investigational prostate cancer therapy; Artificial intelligence (AI) Segmentation and primary characterisation of prostate cancer lesions using models trained on 68Ga-PSMA-11 image datasets; Nobody

First Patients in Canada Imaged with Illuccix: Now Commercially Available Nationwide

MELBOURNE, Australia, May 2, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces first patients have been imaged in Canada with its commercially available prostate cancer imaging agent, Illuccix [kit for the preparation of gallium (68Ga) PSMA-11 for intravenous injection]. With Illuccix now available nationwide in Canada through Telix's partner Isologic Innovative Radiopharmaceuticals (Isologic), INITIO Medical Group in Burnaby, BC (INITIO) became one of the first sites to administer this novel PSMA-PET imaging agent that can help healthcare professionals diagnose the stage and spread of prostate cancer - an important step for men with this disease. Illuccix, after radiolabeling with gallium (68Ga), is indicated for use with positron emission tomography (PET) of prostate specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are suitable for initial definitive therapy; with suspected re

Olaratumab Antibody Licensed from Lilly Demonstrates Proof of Concept as a Theranostic Radiopharmaceutical

MELBOURNE, Australia, April 17, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces successful preclinical development of radiolabelled olaratumab, an antibody licensed from Eli Lilly and Company (Lilly). Telix has demonstrated proof-of-concept (PoC) of using olaratumab to selectively deliver both diagnostic and therapeutic radiation to tumours as a radiopharmaceutical moiety and has produced a candidate for clinical translation. Telix will now progress to first-in-human clinical studies based on these highly encouraging results. In April 2022, Telix secured the exclusive worldwide rights to develop and commercialise radiolabelled forms of olaratumab for the diagnosis and treatment of human cancers.[1] Olaratumab was originally developed as a naked (non-radiolabelled) monoclonal antibody targeting Platelet Derived Growth Factor Receptor Alpha (PDGFR), a target expressed in multiple tumour types. Olaratumab has a well-established clinical safe

Chinese NMPA Approves Study of Telix Brain Cancer Therapy Candidate

MELBOURNE, Australia, April 11, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved a Phase I study of TLX101 investigational therapy (4-L-[131I] iodo-phenylalanine, or 131I-IPA) in Chinese patients with newly diagnosed glioblastoma (GBM). The investigational new drug (IND) application was submitted by Telix's partner in the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The Phase I study is required to establish the safety profile of this therapeutic candidate in a Chinese patient population, thus enabling Chinese patients to be enrolled in Telix's planned global pivotal registration trial for TLX101. This is the first of Telix's investigational therapies to move into a clinical trial with Grand Pharma. The IPAX-1 study of TLX101 (ClinicalTrials.gov Identifier: NCT03849105)met its primary objective d

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