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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 ....

New York , United States , United Kingdom , Scottt Tagawa , Nat Lenzo , Colin Hayward , Kyahn Williamson , Corporate Communications , Telix Pharmaceuticals Limited Disclosure Committee , Drug Administration , Prnewswire Telix Pharmaceuticals Limited , European Union , Telix Pharmaceuticals , Australian Therapeutic Goods Administration , Genesiscare Group Clinical , Australian Securities Exchange , Health Canada , Pharmaceuticals Limited , Genesiscare Group Clinical Director Theranostics , Telix Chief Medical Officer , Marketing Authorisation Applications , Telix Pharmaceuticals Limited , The Study Has Achieved Its Primary Objectives , Onfirming The Safety And Tolerability Profile Of Tlx591 Administered In Two Doses , Wo Weeks Apart In Combination With Standard Of Care Soc Preliminary Activity Demonstrates Meaningfulpsa 1 Reduction Monitoring Patients Is Ongoing , Ncluding For Rpfs 2 Findings Reinforce The Potential Advantages Of This First In Class Radio Antibody Drug Conjugate Radc Investigational Therapy ,

First Patient Dosed in STARSTRUCK Study of TLX250 Targeted Radiation Therapy in Combination with Merck Investigational DNA-PK Inhibitor, Peposertib

MELBOURNE, Australia, July 19, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)today announces that the first patient has been dosed in a Phase I study of the Company's investigational targeted radiation therapy, TLX250, in combination with a Merck KGaA, Darmstadt, Germany (Merck) DNA-dependent protein kinase (DNA-PK) inhibitor candidate, peposertib (M3814). The study is being conducted in patients with solid tumours expressing carbonic-anhydrase IX (CAIX), a potential pan-cancer target. STARSTRUCK (ClinicalTrials.gov Identifier: NCT05868174) is a Phase Ib, open label, single-arm, multicentre dose escalation and dose expansion study to evaluate the safety profile, dosing and activity of TLX250 (177Lu-DOTA-girentuximab) in combination with the DNA damage response inhibitor (DDRi) peposertib, which is an inhibitor of DNA-PK. The target population is patients with CAIX-expressing solid tumours that are relapsed or refractory to standard therapies. Up to ....

United States , United Kingdom , Merck Ddri , Nat Lenzo , Kyahn Williamson , Colin Hayward , Genesiscare Murdoch , Health Canada , Telix Pharmaceuticals , Merck Kga , European Union , Merck Kgaa , Australian Therapeutic Goods Administration , Prnewswire Telix Pharmaceuticals Limited , Genesiscare Group Clinical , Drug Administration , Australian Securities Exchange , Corporate Communications , Pharmaceuticals Limited , Professor Nat Lenzo , Genesiscare Group Clinical Director Theranostics , Chief Medical Officer , Telix Pharmaceuticals Limited , July 19 , 023 Prnewswire Telix Pharmaceuticals Limited Asx Tlx , He Company Today Announces That The First Patient Has Been Dosed Ina Phasei Study Of 39s Investigational Targeted Radiation Therapy ,

Telix to Supply Bayer with Illuccix for Global Phase III Prostate Cancer Study

MELBOURNE, Australia, May 8, 2023 /PRNewswire/ Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into an agreement with Bayer AG (Bayer) to supply Illuccix (TLX591-CDx, kit for the preparation of gallium Ga 68 gozetotide injection)[1] for the Phase III ARASTEP study (ClinicalTrials.gov Identifier: NCT05794906). This global study is investigating the efficacy of Bayer's androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence who have no evidence of metastatic disease by conventional imaging and a positive PSMA-PET/CT[2] at baseline. The study will enrol up to 750 patients across various sites such as in Europe, Japan and the United States. The more sensitive PSMA imaging may identify prostate cancer lesions not detectable by conventional imaging such as computed tomography (CT) scans, magnetic resonan ....

United States , United Kingdom , Bayer Cross , Kyahn Williamson , Colin Hayward , Orion Corporation , European Union , Prnewswire Telix Pharmaceuticals Limited , Corporate Communications , Drug Administration , Australian Securities Exchange , Health Canada , Australian Therapeutic Goods Administration , Telix Pharmaceuticals , Bayer Ag , Pharmaceuticals Limited , Chief Medical Officer , Telix Pharmaceuticals Limited , May 8 , 023 Prnewswire Telix Pharmaceuticals Limited Asx Tlx , He Company Today Announces That It Has Entered Into An Agreement With Bayer Ag To Supply Illuccix Tlx591 Cdx , It For The Preparation Of Gallium Ga 68 Gozetotide Injection 1 Phase Iii Arastep Study Clinicaltrials Gov Identifier Nct05794906 This Global Is Investigating Efficacy Bayer 39s Androgen Receptor Inhibitor Ari Darolutamide Plus Deprivation Therapy Adt Versus Alone In Hormone Sensitive Prostate Cancer , N Patients With High Risk Biochemical Recurrence Who Have No Evidence Of Metastatic Disease By Conventional Imaging Anda Positive Psma Pet Ct 2 At Baseline The Study Will Enrol Up To 750 Across Various Sites Such As In Europe , Apan And The United States More Sensitive Psma Imaging May Identify Prostate Cancer Lesions Not Detectable By Conventional Such As Computed Tomography Ct Scans , Agnetic Resonance Imaging Mri And Bone Scans Telix Chief Medical Officer , R Colin Hayward Stated ,

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 ....

United States , New Zealand , North Vancouver , British Columbia , Philip Cohen , Kevin Richardson , Andre Gagnon , Kyahn Williamson , Telix Pharmaceuticals Limited , Health Canada , Drug Administration , Group In Burnaby , Australian Securities Exchange , Telix Pharmaceuticals , Australian Therapeutic Goods Administration , Nuclear Medicine , Public Health Agency Of Canada , Corporate Communications , Division Head , Isologic Innovative Radiopharmaceuticals , Lions Gate Hospital , Chief Executive Officer , Telix Americas , Western Canada , Health Agency , May 2 ,

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 ....

United Kingdom , United States , Eli Lilly , Michael Wheatcroft , Kyahn Williamson , American Cancer Society , Australian Securities Exchange , Health Canada , Prnewswire Telix Pharmaceuticals Limited , Corporate Communications , Drug Administration , Company Lilly , Telix Pharmaceuticals Limited Disclosure Committee , Telix Pharmaceuticals , Australian Therapeutic Goods Administration , Pharmaceuticals Limited , Platelet Derived Growth Factor Receptor Alpha , Soft Tissue Sarcoma , Positron Emission Tomography , Chief Scientist , Telix Pharmaceuticals Limited , Cancer Society , Adv Med , April 17 , 023 Prnewswire Telix Pharmaceuticals Limited Asx Tlx , He Company Today Announces Successful Preclinical Development Of Radiolabelled Olaratumab ,