MELBOURNE, Australia and KYOTO, Japan, May 8, 2023 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today reveals that it has actually participated in a contract with Bayer AG (Bayer) to provide Illuccix® (TLX591-CDx, package for the preparation of gallium Ga 68 gozetotide injection)[1] for the Phase III ARASTEP research study (ClinicalTrials.gov Identifier: NCT05794906). This worldwide research study is examining the effectiveness of Bayer’s androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation treatment (ADT) versus ADT alone in hormone-sensitive prostate cancer, in clients with high-risk biochemical reoccurrence who have no proof of metastatic illness by standard imaging and a positive PSMA-PET/CT[2] at standard.
The research study will register as much as 750 clients throughout numerous websites in Japan, along with in Europe and the United States. The more delicate PSMA imaging might recognize prostate cancer sores not noticeable by standard imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans.
Telix Chief Medical Officer, Dr Colin Hayward mentioned, “We are delighted to provide Bayer and a variety of scientific websites in this crucial research study. This is reflective of Telix’s distinct dedication to providing sophisticated prostate cancer imaging worldwide, consisting of in Japan. The usage of PSMA-PET/CT in this setting is illustrative of the capacity for this imaging method to move beyond medical diagnosis to an illness management tool.”
About Bayer AG
Bayer is an international enterprise with core proficiencies in the life science fields of healthcare and nutrition. Its product or services are created to help individuals and the world grow by supporting efforts to master the significant difficulties provided by a growing and aging worldwide population. Bayer is devoted to driving sustainable advancement and producing a positive effect with its businesses. At the exact same time, the Group intends to increase its making power and produce worth through development and development. The Bayer brand name represents trust, dependability and quality throughout the world. In financial 2022, the Group utilized around 101,000 individuals and had sales of 50.7 billion euros. R&D expenditures prior to unique products totaled up to 6.2 billion euros. For more details, go to www.bayer.com.
BAYER, the Bayer Cross and NUBEQA are signed up hallmarks of Bayer.
About darolutamide
Darolutamide is an oral ARi with an unique chemical structure that binds to the receptor with high affinity and displays strong antagonistic activity, thus hindering the receptor function and the development of prostate cancer cells.
The item is authorized under the brand Nubeqa™ in more than 80 nations worldwide for the treatment of clients with non-metastatic castration-resistant prostate cancer (nmCRPC). It is likewise authorized for the treatment of clients with metastatic hormone-sensitive prostate cancer (mHSPC) in a variety of markets consisting of the U.S., Japan, China and the EU. The substance is likewise being examined in additional research studies throughout numerous phases of prostate cancer.
Darolutamide is established collectively by Bayer and Orion Corporation, an internationally operating Finnish pharmaceutical business.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical business concentrated on the advancement and commercialisation of diagnostic and restorative radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with global operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is establishing a portfolio of clinical-stage items that intends to resolve considerable unmet medical requirement in oncology and unusual illness. Telix is noted on the Australian Securities Exchange (ASX: TLX).
Visit www.telixpharma.com for additional details about Telix, consisting of information of the latest share cost, statements made to the ASX, financier and expert discussions, press release, occasion information and other publications that might be of interest. You can likewise follow Telix on Twitter (@TelixPharma) and LinkedIn.
About Illuccix®
Telix’s lead item, Illuccix® (gallium-68 (68Ga) gozetotide (likewise called 68Ga PSMA-11) injection), has actually been authorized 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 likewise advancing a marketing authorisation application for this investigational prospect in the United Kingdom and the European Union.[6]
Telix Japan Contact
Dr. Shintaro Nishimura
President, Telix Pharmaceuticals Japan K.K.
Email: [email protected]
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: [email protected]
Legal Notices
This statement is not meant as promo or marketing directed to any health care expert or other audience in any nation around the world (consisting of Australia, United States and the United Kingdom). This statement might consist of positive declarations that associate with awaited future occasions, monetary efficiency, strategies, methods or business advancements. Forward-looking declarations can normally be recognized by the usage of words such as “might”, “anticipate”, “plan”, “strategy”, “price quote”, “prepare for”, “outlook”, “projection” and “assistance”, or other comparable words. Forward-looking declarations include understood and unidentified dangers, unpredictabilities and other elements that might trigger our real outcomes, levels of activity, efficiency or accomplishments to vary materially from any future outcomes, levels of activity, efficiency or accomplishments revealed or indicated by these positive declarations. Forward-looking declarations are based upon the Company’s good-faith presumptions regarding the monetary, market, regulative and other dangers and factors to consider that exist and impact the Company’s business and operations in the future and there can be no guarantee that any of the presumptions will show to be right. In the context of Telix’s business, positive declarations might consist of, however are not restricted to, declarations about: the initiation, timing, development and outcomes of Telix’s preclinical and scientific research studies, and Telix’s research study and advancement programs; Telix’s capability to advance item prospects into, register and effectively total, scientific research studies, consisting of multi-national scientific trials; the timing or probability of regulative filings and approvals, producing activities and item marketing activities; the commercialisation of Telix’s item prospects, if or when they have actually been authorized; quotes of Telix’s expenditures, future incomes and capital requirements; Telix’s monetary efficiency; advancements associating with Telix’s rivals and market; and the rates and compensation of Telix’s item prospects, if and after they have actually been authorized. Telix’s real outcomes, efficiency or accomplishments might be materially various from those which might be revealed or indicated by such declarations, and the distinctions might be unfavorable. Accordingly, you must not position unnecessary dependence on these positive declarations.
Except as needed by appropriate laws or guidelines, Telix does not carry out to openly update or evaluate any positive declarations. Past efficiency cannot be depended on as a guide to future efficiency. Readers must read this statement together with our product dangers, as divulged in our most just recently submitted reports with the ASX and on our website.
©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo design are hallmarks of Telix Pharmaceuticals Limited and its affiliates (all rights scheduled).
[1] For regulative factors, Telix describes its 68 Ga-PSMA-11 package as Illuccix in markets where it has actually received regulative approval, and TLX591-CDx when describing its usage in both authorized and unapproved markets. Registrations differ nation to nation. Always describe regional 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 3 April 2023.
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SOURCE Telix Pharmaceuticals Limited
