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Iconic computer games characters reimagined to celebrate Black culture | Media centre

Teesside University staff and alumni have been involved in a unique project to reimagine well-known computer game characters and help shine a spotlight on diversity within the games industry.

Haiti , Guyana , London , City-of , United-kingdom , Haitian , British , Lara-croft , Jason-williams , Chella-ramanan , Jason-william , Harley-quinn

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 patients for rADC-based PSMA therapy and to confirm the biodistribution of the rADC investigational therapy. The primary clinical objective was to determine whole body distribution and organ radiation and assess the safety and tolerability of TLX591, when administered in combination with SoC in second-line mCRPC. The evaluable population was 28 patients (of a total 30 enrolled in the study). Patients received two (2) single intravenous (IV) infusions of TLX591, fourteen (14) days apart. Cohort 1 (5 patients) received a 27mCi dose followed by a 76 mCi dose for accuracy of biodistribution determination. Cohort 2 (23 patients) received two 76mCi doses. The study achieved its primary objectives, confirming the safety and tolerability profile of TLX591 administered in two cycles,14 days apart (total cumulative dose 152mCi). The results reinforce the clinical utility of the short, fractionated dosing regimen. Key results and observations Dosimetry and biodistribution Consistent lesion delineation between TLX591 and68Ga-PSMA-11 imaging, within the detection sensitivity and resolution limits of SPECT[4] Excellent uptake and retention intumour and metastases up to 14 days post injection Radiation exposure to key organs is well within prescribed safety limits The highest absorbed dose was in the liver (clearance organ), with minimal uptake in exocrine (salivary) glands Long retention period is evidence ofinternalisation and ability to efficiently deliver payload to tumour Hematologic profile and adverse events Grade 3thrombocytopenia (25%) and neutropenia (38%) events in line with profile expected for this class of therapy. Similarly for Grade 4 hematologic events - thrombocytopenia (25%) and neutropenia (4%) Serious adverse events (SAEs) observed were generally lower than in earlier studies conducted at the same dose level, reflective of the SELECT study being conducted in a healthier patient population Hematologic events were transient and reversible Four patients (17%) received intervention in the form of platelets, growth factors or both All treatment related non-hematologic events were Grade 1 or Grade 2 and generally mild Preliminary anti-tumour activity 64% of patients (baselinePSA and full dose) had a PSA reduction, with 27% demonstrating a 30% reduction and 18% demonstrating a 50% reduction. PSA and rPFS monitoring is ongoing Scott T. Tagawa, MD, Professor of Medicine and Urology in New York said, "Preliminary results from the ProstACT SELECT study build on prior studies of TLX591 and underline the potential advantages of an antibody-based approach. Latest data provides further evidence of the long retention and internalisation of TLX591 in the tumour (and metastases), which may maximise the cell-killing effect of the 177Lu radioisotope at the site of the tumour." Nat Lenzo, MD, GenesisCare Group Clinical Director Theranostics and top recruiter onto the ProstACT SELECT study commented, "It is really exciting to see development of this next-generation PSMA-targeting radiotherapeutic progressing. This study confirms the suitability of the short, simple treatment duration with two doses administered two weeks apart which is attractive to physicians and patients. The safety and tolerability data also demonstrates the potential for this therapy to reduce undesirable side effects, while delivering a hematologic toxicity profile that is both tolerable and manageable." Colin Hayward, Telix Chief Medical Officer, added, "TLX591 is being designed to integrate with current standard of care, demonstrative of Telix's continued innovation in prostate cancer treatment. The SELECT study provides further validation of the potential of TLX591, a first-in-class rADC therapy and the use of PSMA imaging with small molecules to select patients for antibody-based PSMA therapy." Investigation of TLX591 is continuing in the Phase III ProstACT GLOBAL study (ClinicalTrials.gov ID NCT04876651), open for enrolment in Australia and expected to commence in the United States in 2024. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn. TLX591 has not received a marketing authorisation in any jurisdiction. Telix's lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),[5] by the Australian Therapeutic Goods Administration (TGA),[6] and by Health Canada.[7] Telix is also progressing Marketing Authorisation Applications for 68Ga-PSMA-11 in the United Kingdom, the European Union[8] and Brazil. Telix Investor Relations Ms.Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: kyahn.williamson@telixpharma.com This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context ofTelix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and

New-york , United-states , Japan , Brazil , Australia , Switzerland , United-kingdom , Melbourne , Victoria , Belgium , Canada , Australian

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 Left Behind (NOBLE) Registry of Telix's single photon emission computed tomography (SPECT)-based prostate cancer imaging agent TLX599-CDx;[1] and, A preclinical evaluation of carbonicanhydrase IX- (CAIX)-targeted lutetium-177 radionuclide therapy in combination with immune checkpoint inhibition. Dr Colin Hayward, Telix Chief Medical Officer, said, "We are pleased to be so well represented at this year's EANM Annual Congress, with a sponsored symposium and abstracts accepted across Telix's late-stage prostate and kidney cancer imaging and therapy programs. In addition, our innovations in AI and quantum computing for prostate cancer segmentation and characterisation will be featured in an oral presentation. "Once again, we will be supporting the EANM Sanjiv Sam Gambhir Young Investigator Award, an exciting opportunity for a junior physician or scientist to further develop their career in radiopharmaceuticals. We look forward to seeing you at booth number 241 to discuss Telix's industry leading theranostic pipeline and opportunities for collaboration." EANM presentation details are as follows: Sponsored Symposium: Personalised diagnostics in urological cancers: the promise of nuclear medicine Chairperson:Professor Stefano Fanti, Director of Nuclear Medicine Division and of PET Unit - Policlinico S.Orsola, Bologna, Italy Introduction: How PSMA PET dusted off the Management of Prostate Cancer. Professor Stefano Fanti. Prostate Cancer Imaging: is there only one PSMA-PET? Dr. Macarena Rodriguez Fraile, Nuclear Medicine Clinica Universidad de Navarra, Pamplona, Spain Next Generation Imaging in Urology: What's new in Bladder and Kidney Cancers. Prof.dr. Karolien Goffin, Nuclear Medicine, University Hospital Leuven - KU Leuven, Leuven, Belgium. The Use of Artificial Intelligence in Prostate Cancer Management. Dr. Laszlo Papp, Center for Medical Physics and Biomedical Engineering (CMPBME), Medical University of Vienna, Vienna, Austria. Date & Time: Sunday, 10 September, 2023, 1:15 - 2:45 PM (CEST). Session:Theranostics Track - Oncology & Theranostics Committee / EARL - Featured Session: Old but Novel Techniques Title:89Zr-DFO-girentuximab PET/CT imaging for clear cell renal cell carcinoma - ZIRCON study results of diagnostic performance, including in very small lesions (oral presentation) Date and Time: 10-Sep-23, 4:20 - 4:30 PM Presenter: Clement Bailly, Nantes University Hospital, Nantes, FRANCE Presentation ID: OP-194 Session:Cutting Edge Science Track - TROP Session: Segmentation and Denoising Title:Using a 3-D UNet artificial intelligence model to segment PSMA-avid lesions in 68Ga-PSMA-11 PET/CT images (top-rated oral presentation) Date and Time: 10-Sep-23, 4:55 - 5:05 PM Presenter: Simon Wail, Telix Pharmaceuticals, North Melbourne, AUSTRALIA Presentation ID: OP-222 Session:M2M Track - TROP Session: TME and Therapy: Direct Targeting and Secondary Effects Title:Evaluation of Therapeutic and Immunological Action of CAIX-Targeted Lutetium-177 Radionuclide Therapy Combined with Immune Checkpoint Inhibition (top-rated oral presentation) Date and Time: 11-Sep-23, 10:15 - 10:25 AM Presenter: Simone Kleinendorst, Department of Medical Imaging, Radboud University Medical Center, Nijmegen, NETHERLANDS Presentation ID: OP-358 Session: Clinical Oncology Track - TROP Session: Prostate Cancer Biochemical Recurrence Title: The imaging characteristics of theranostic 99mTc/188Re-PSMA-GCK01 is equivalent to dedicated diagnostic 99mTc-HYNIC-iPSMA in prostate cancer (top-rated oral presentation) Date and Time: 11-Sep-23, 6:05 - 6:15 PM Presenter: Eduards Mamlins, Department of Nuclear Medicine, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf, Duesseldorf, GERMANY Presentation ID: OP-512 Session:e-Poster Presentations Session 10 - Oncology & Theranostics Committee: Haematological and Abdominal Malignancies / localised Treatments Title:NOBLE (Nobody Left Behind) Registry: Initial Experience of [99mTc]-HYNIC-iPSMA Imaging in the Detection of Prostate Cancer (oral e-poster presentation) Date and Time: 12-Sep-23, 10:53 - 10:57 AM Presenter: Fuad Novruzov, Department of Nuclear Medicine Azerbaijan National Centre of Oncology, Baku AZERBAIJAN Presentation ID: EPS-206 Session: Cutting Edge Science Track - TROP Session: AI Methods and Applications Title: Primary prostate characterization in PSMA-11 PET on real quantum computers (top-rated oral presentation) Date and Time: 12-Sep-23, 3:00 - 03:10 PM Presenter: Laszlo Papp, Medical University of Vienna, Vienna, AUSTRIA Presentation ID: OP-706 Session: Clinical Oncology Track - TROP Session: Prostate Cancer Treatment Title:ProstACT GLOBAL: A Phase 3 Study of 177Lu-DOTA-rosopatamab (TLX591) With and Without the Best Standard of Care for Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer Progressing Despite Prior Treatment with a Novel Androgen Axis Drug (top-rated oral presentation) Date and Time: 12-Sep-23, 3:30 - 3:40 PM Presenter: Neel Patel, Telix Pharmaceuticals, North Melbourne, AUSTRALIA Presentation ID: OP-718 Session: D: Technical Studies -> D5 Radiopharmacy/ Radiochemistry -> D57 Radiopharmaceutical Preparation and Quality Control Title:The Optimization of the Current ININ Method of Lu-177-DOTA-HYNIC-iPSMA (e-poster) Presenter: Yehia Omar, Misr Radiology Center, Cairo, EGYPT Presentation ID: EP-0880 About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn. Telix's lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),[2] by the Australian Therapeutic Goods Administration (TGA),[3] and by Health Canada.[4]Telix is also progressing Marketing Authorisation Applications for 68Ga-PSMA-11 in the United Kingdom and the European Union.[5] Telix Investor Relations Ms.Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: kyahn.williamson@telixpharma.com Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, st

Switzerland , Japan , Egypt , France , Germany , Nijmegen , Gelderland , Netherlands , Azerbaijan , Vienna , Wien , Austria

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 80 patients will be assessed in this study in Australian sites. The clinical hypothesis is that the combination of TLX250 and a DNA-PK inhibitor provides an enhancement in potency through their synergistic action on cancer cells. Targeted radiation effectively induces DNA damage in targeted cancer cells and the DNA-PK inhibitor may act to prevent the cell from repairing this damage, resulting in higher potency at lower doses. This hypothesis was confirmed in preclinical studies, conducted under a strategic research collaboration between Merck and Telix announced in 2019,[1] and provided evidence that the combined effect of Merck's investigational DNA-PK inhibitor peposertib with Telix's targeted radiation candidate has potential to significantly improve efficacy and reduce the required radiation dose for tumour reduction and remission, compared to targeted radiation alone. Principal Investigator for the STARSTRUCK study, Professor Nat Lenzo, GenesisCare Group Clinical Director Theranostics said, "The treatment of advanced cancer can be extremely challenging. We are pleased to support the commencement of this study with Telix to help determine if there is a potential future clinical benefit regarding the combination of molecular targeted radiation and DNA-PK inhibitors." Telix Chief Medical Officer, Dr. Colin Hayward stated,"Preclinical data has shown excellent combination response, which has potential to translate to additional response or more tolerable treatment regimens in patients. We would like to thank Prof. Lenzo and his clinical team at GenesisCare Murdoch, as well as the patients who will contribute to this important study." Merck and Telix are continuing the initial scientific collaboration to further explore and optimise the combination of TLX250 or other next-generation targeted radiation therapy candidates with Merck's DDRi compounds in preclinical studies. About TLX250 TLX250 (177Lu-DOTA-girentuximab) is an antibody-based therapeutic platform that targets CAIX, a cell surface protein that is highly expressed in several human cancers, and is currently the subject of the STARLITE-1 (ClinicalTrials.gov Identifier: NCT05663710) and STARLITE-2 (NCT05239533) studies in combination with immunotherapy.[2] High CAIX tumour expression is generally correlated with poor prognosis. Telix's companion investigational diagnostic imaging agent TLX250-CDx (89Zr-DFO-girentuximab) was the subject of a successful global Phase III trial (ZIRCON trial, NCT03849118), which completed enrolment and reported positive top-line data during 2022.[3] Analyses of primary endpoints and key secondary endpoints of the ZIRCON trial were presented to the medical community for the first time at ASCO GU on 18 February 2023.[4] TLX250-CDx is currently being investigated in the Phase II STARBURST study (ClinicalTrials.gov Identifier: NCT05563272) exploring CAIX expression in patients with a diverse range of solid tumours for potential diagnostic and therapeutic applications.[5] About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Visit www.telixpharma.comfor further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on Twitter (@TelixPharma) and LinkedIn. TLX250 and TLX250-CDx have not received a marketing authorisation in any jurisdiction.Telix's lead product, Illuccix (gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection), has been approved by the U.S. Food and Drug Administration (FDA),[6] and by the Australian Therapeutic Goods Administration (TGA),[7] and by Health Canada.[8] Telix is also progressing marketing authorisation applications for this investigational candidate in the United Kingdom and the European Union.[9] Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: kyahn.williamson@telixpharma.com Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking s

Melbourne , Victoria , Australia , Canada , United-states , Japan , Switzerland , Belgium , United-kingdom , Australian , Merck-ddri , Nat-lenzo

URGENT! Immediate Need for Type O+ blood in Southeast Minnesota

Urgent and immediate need for O+ blood has been issued by the Blood Donor Center - Mayo Clinic for Southeast Minnesota.

Minnesota , United-states , Hilton-building , Mayo-clinic-in-rochester , Jessica-williams , Blood-donor-program , Mayo-clinic-blood-donor-program , Mayo-clinic-blood-donor-center , Roll-up-your , Donor-program , Mayo-clinic , Donate-blood

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 resonance imaging (MRI) and bone scans. Telix Chief Medical Officer, Dr Colin Hayward stated, "We are pleased to supply Bayer and a number of clinical sites in this important study, reflective of Telix's unique commitment to delivering advanced prostate cancer imaging globally. The use of PSMA-PET/CT in this setting is illustrative of the potential for this imaging modality to move beyond diagnosis to a disease management tool." About Bayer AG Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com. BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer. About darolutamide Darolutamide is an oral ARi with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The product is approved under the brand name Nubeqa in more than 80 countries around the world for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). It is also approved for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in a number of markets including the U.S., Japan, China and the EU. The compound is also being investigated in further studies across various stages of prostate cancer. Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Visit www.telixpharma.comfor further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on Twitter (@TelixPharma) and LinkedIn. About Illuccix Telix's lead product, Illuccix (gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection), has been approved by the U.S. Food and Drug Administration (FDA),[3] and by the Australian Therapeutic Goods Administration (TGA),[4] and by Health Canada.[5] Telix is also progressing a marketing authorisation application for this investigational candidate in the United Kingdom and the European Union.[6] Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Corporate Communications and Investor Relations Email: kyahn.williamson@telixpharma.com Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website. 2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved). [1] For regulatory reasons, Telix refers to its 68 Ga-PSMA-11 kit as Illuccix in markets where it has received regulatory approval, and TLX591-CDx when referring to its use in both approved and unapproved markets. Registrations vary country to country. Always refer to local labelling. [2] Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography. [3]Telix ASX disclosure 20 December 2021. [4]Telix ASX disclosure 2 November 2021. [5]Telix ASX disclosure 14 October 2022. [6]Telix ASX disclosure

United-states , United-kingdom , Australia , Switzerland , China , Melbourne , Victoria , Japan , Canada , Finland , Belgium , Finnish

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 recurrence with elevated serum prostate specific antigen (PSA) level. Illuccix is the first PSMA-PET imaging agent to have been granted regulatory approval in Canada. Health Canada became the third regulatory body worldwide to approve Illuccix, which is also commercially available in Australia, New Zealand and the United States. Dr. Philip Cohen, INITIO Director and Division Head, Nuclear Medicine, Lions Gate Hospital in North Vancouver said, "Nuclear isotope therapy enters a new era with the ability to see and diagnose invisible cancers based on their molecular "signature" and then target them based on the same signature. Now if we can see the cancer we can treat it, and potentially control, and eventually someday cure this terrible disease." Andre Gagnon, President of Isologic added, "PSMA-PET is emerging as a standard of care worldwide, and it is tremendous that we can now provide Canadian physicians and their patients with this innovative new diagnostic tool via our national network, servicing 265 hospitals and clinics." Kevin Richardson, Chief Executive Officer for Telix Americas continued, "The launch of Illuccix in Canada marks an important milestone for Telix and the ~24,000 men who will be diagnosed with prostate cancer in the country this year.[1] Widespread availability of PSMA-PET imaging, via Telix's distribution partner Isologic, will help deliver on a significant unmet medical need for the men in Canada and their families affected by this disease." Healthcare professionals in Canada can order Illuccix kits by email orders@isologicradiopharm.caor by phone 1-877-505-4711 ext 0. Unit doses can be ordered from your local radiopharmacy. About Initio INITIO is Western Canada's only private PET/CT scan facility with over 20 years' experience, offering Rapid PET/CT and CT scans and nuclear medicine treatments with no wait list. INITIO has diagnostic scanning for cancer, cognitive impairment, and cardiac sarcoidosis, and now offers gallium-68 PSMA-PET imaging and lutetium-177 PSMA therapy for prostate cancer. With these latest additions, INITIO Medical Group reaffirms its commitment to providing the most advanced and effective treatments to patients and looks forward to the positive impact these will have on the lives of those affected by prostate cancer. www.initiomedical.ca About Isologic Innovative Radiopharmaceuticals Isologic is a Canadian radiopharmaceutical company, dedicated to nuclear medicine and radiopharmaceutical production. The head office is in Montreal, Quebec, and our sites are in Dorval, Lachine, Quebec, Toronto, Burlington, Ottawa, and Vancouver. Isologic is the leading Canadian manufacturer of positron-emitting radiopharmaceuticals (PERs) and distributor of radiopharmaceuticals for photon emission tomography (PET). Isologic operates an internal logistics and delivery structure, which allows it to control its radioisotope autonomy. www.isologicradiopharm.ca LinkedIn About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on Twitter (@TelixPharma) and LinkedIn. About Illuccix Telix's lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),[2] and by the Australian Therapeutic Goods Administration (TGA),[3] and by Health Canada.[4] [1]Public Health Agency of Canada, 2021. [2]Telix ASX disclosure 20 December 2021. [3]Telix ASX disclosure 2 November 2021. [4]Telix ASX disclosure 14 October 2022. Illuccix is a Schedule C radiopharmaceutical product. Click herefor approved product monograph in Canada. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Corporate Communications and Investor Relations Email: kyahn.williamson@telixpharma.com Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking stateme

Melbourne , Victoria , Australia , United-states , Toronto , Ontario , Canada , Ottawa , Quebec , New-zealand , Switzerland , Japan

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 safety profile, a favourable toxicology dataset and advanced manufacturing package in relation to Lilly's development program, which Telix expects to be able to leverage for future development as a radiopharmaceutical drug product. Telix's initial development PoC has focused on a rare type of cancer known as Soft Tissue Sarcoma (STS). External beam radiation is a key part of the standard of care for STS, which may therefore be a suitable clinical target for novel radionuclide therapy, particularly for alpha-emitting radionuclides. The ability of olaratumab to target PDGFR in the STS tumour microenvironment makes it a highly novel and high-potential radiopharmaceutical candidate. Telix has now completed its preclinical evaluation, with results sufficiently encouraging to advance development toward initial human clinical trials, in line with planned R&D expenditure for 2023/24. The agent has been assigned formal candidate status in Telix's development pipeline (to be denoted as TLX300-CDx/TLX300 for the diagnostic/patient selection tool and therapeutic, respectively). Specifically, these studies have shown that olaratumab can be bioconjugated with multiple chelators (including Telix's proprietary DFO-squaramide chelator), radiolabelled with zirconium-89 (89Zr) for imaging by Positron Emission Tomography (PET) and used to demonstrate specific delivery of radiation to STS cancer cells to show proof of concept in xenograft tumour mouse models. Furthermore, olaratumab radiolabelled with therapeutic radionuclide payloads has demonstrated in vivo efficacy with significant reduction in tumour volumes in relevant disease models, even after administration of a single dose. The Company is preparing to publish preliminary findings. Telix Chief Scientist, Dr Michael Wheatcroft stated, "Building on Telix's proven track record in acquiring and developing novel radiopharmaceutical assets, it is extremely pleasing to demonstrate the adaptation of this traditional biologic agent for future potential use as a targeted radiopharmaceutical. TLX300 will initially be evaluated in a first-in-human clinical study that is designed to inform both the potential efficacy (dosimetry) and safety profile of this research candidate as a therapeutic, demonstrating the development advantage of a theranostic approach." About Soft Tissue Sarcoma (STS) Soft tissue sarcoma is a complex disease that encompasses a diverse group of relatively rare cancers, with more than 50 histological subtypes. In the United States (U.S.), it is estimated that 13,040 new cases and 5,150 deaths were caused by STS in 2019, representing 0.75% of overall cancer incidence and 0.84% of overall cancer mortality.[2]In Europe, nearly 23,600 new STS cases rose annually, and the crude incidence rate was 4.7 per 100,000.[3]Approximately 39,900 new STS cases occurred nationwide in China in 2019, accounting for 1.05% of overall cancer incidence.[4]The crude incidence rate was 2.91/100,000 and generally increased with age. Standard treatment for soft tissue sarcoma includes surgery, radiation therapy and/or chemotherapy. For patients with advanced, unresectable, or metastatic disease, treatment typically involves chemotherapy with single agents (e.g., doxorubicin) or anthracycline-based combination regimens. However, the prognosis for these patients remains poor, with treated patients with metastatic disease having a median overall survival of around 12-18 months.[5] About olaratumab Olaratumab (previously marketed under the brand name, Lartruvo) was originally developed as a monoclonal antibody targeting PDGFR. Olaratumab was granted "Accelerated Approval" in the U.S. and "Conditional Approval" in the EU based on Phase II trial data which showed a 1-year survival benefit in patients with STS, when given in combination with standard chemotherapy. Olaratumab was voluntarily withdrawn from the market by Lilly following the failure of the Phase III ANNOUNCE clinical trial, in which olaratumab did not improve survival for patients. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on Twitter (@TelixPharma) and LinkedIn. Telix's lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),[6] and by the Australian Therapeutic Goods Administration (TGA),[7] and by Health Canada.[8] Telix is also progressing a marketing authorisation application for this investigational candidate in the United Kingdom.[9] Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Corporate Communications and Investor Relations Email: kyahn.williamson@telixpharma.com This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development pro

China , United-kingdom , Belgium , Australia , Switzerland , Canada , United-states , Melbourne , Victoria , Japan , American , Australian

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 demonstrating safety and tolerability profile of intravenous 131I-IPA administered concurrently with external beam radiation therapy (EBRT) in patients with recurrent GBM. The study also delivered encouraging preliminary efficacy data for further evaluation, demonstrating a median overall survival of 13 months from the initiation of treatment in the recurring setting, or 23 months from initial diagnosis.[1] Telix has now initiated the IPAX-2 study (ClinicalTrials.gov Identifier: NCT05450744) in Australian sites to confirm the safety profile of TLX101 as a front-line therapy in combination with standard of care treatment, ahead of progressing to a label-indicating Phase II/III study in a larger patient population, IPAX-3. The IPAX-2 study will run concurrently to the study in Chinese patients in the same disease setting. Mr Zhou Chao, CEO Grand Pharma said, "China is a rapid adopter of new radiopharmaceutical theranostics, and the Chinese regulator NMPA - a leading, competent global authority - is increasingly familiar with this class of drug. With over 30,000 patients diagnosed with GBM in China annually,[2] there is very high unmet medical need for new therapeutic options for this disease, which makes studies like this one critical." Dr David N Cade, CEO Telix Asia Pacific added, "Building on the successful IPAX-1 study of TLX101 therapy in patients with recurrent GBM, we are pleased to commence this follow-on study in newly diagnosed Chinese patients. Completion of this Phase I trial is critically important to the development of this asset, as it will enable Chinese patients to be included in the future global registration trial for TLX101 and potentially enable parallel regulatory submissions in Western markets and China. With our partner for Greater China, Grand Pharma, Telix's goal is to provide new treatment options for this aggressive cancer with significant unmet medical need as efficiently as possible in this large market." About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on Twitter (@TelixPharma) and LinkedIn. Telix's lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),[3] and by the Australian Therapeutic Goods Administration (TGA),[4] and by Health Canada.[5] Telix is also progressing a marketing authorisation application for this investigational candidate in the United Kingdom.[6] Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Corporate Communications and Investor Relations Email: kyahn.williamson@telixpharma.com Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website. 2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved). [1] Telix ASX disclosure 21 September 2022. [2]Globocan 2020. [3]Telix ASX disclosure 20 December 2021. [4]Telix ASX disclosure 2 November 2021. [5]Telix ASX disclosure 14 October 2022. [6]Telix ASX disclosure 3 April 2023.

China , Japan , Switzerland , Melbourne , Victoria , Australia , Zhou-chao , Jiangsu , Canada , United-kingdom , United-states , Belgium

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 demonstrating safety and tolerability profile of intravenous 131I-IPA administered concurrently with external beam radiation therapy (EBRT) in patients with recurrent GBM. The study also delivered encouraging preliminary efficacy data for further evaluation, demonstrating a median overall survival of 13 months from the initiation of treatment in the recurring setting, or 23 months from initial diagnosis.[1] Telix has now initiated the IPAX-2 study (ClinicalTrials.gov Identifier: NCT05450744) in Australian sites to confirm the safety profile of TLX101 as a front-line therapy in combination with standard of care treatment, ahead of progressing to a label-indicating Phase II/III study in a larger patient population, IPAX-3. The IPAX-2 study will run concurrently to the study in Chinese patients in the same disease setting. Mr Zhou Chao, CEO Grand Pharma said, "China is a rapid adopter of new radiopharmaceutical theranostics, and the Chinese regulator NMPA - a leading, competent global authority - is increasingly familiar with this class of drug. With over 30,000 patients diagnosed with GBM in China annually,[2] there is very high unmet medical need for new therapeutic options for this disease, which makes studies like this one critical." Dr David N Cade, CEO Telix Asia Pacific added, "Building on the successful IPAX-1 study of TLX101 therapy in patients with recurrent GBM, we are pleased to commence this follow-on study in newly diagnosed Chinese patients. Completion of this Phase I trial is critically important to the development of this asset, as it will enable Chinese patients to be included in the future global registration trial for TLX101 and potentially enable parallel regulatory submissions in Western markets and China. With our partner for Greater China, Grand Pharma, Telix's goal is to provide new treatment options for this aggressive cancer with significant unmet medical need as efficiently as possible in this large market." About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on Twitter (@TelixPharma) and LinkedIn. Telix's lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),[3] and by the Australian Therapeutic Goods Administration (TGA),[4] and by Health Canada.[5] Telix is also progressing a marketing authorisation application for this investigational candidate in the United Kingdom.[6] Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Corporate Communications and Investor Relations Email: kyahn.williamson@telixpharma.com Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website. 2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved). [1] Telix ASX disclosure 21 September 2022. [2]Globocan 2020. [3]Telix ASX disclosure 20 December 2021. [4]Telix ASX disclosure 2 November 2021. [5]Telix ASX disclosure 14 October 2022. [6]Telix ASX disclosure 3 April 2023.

China , Zhou-chao , Jiangsu , Japan , Melbourne , Victoria , Australia , United-states , United-kingdom , Belgium , Switzerland , Canada