First Patient Dosed in IPAX-2 Study of TLX101 Brain Cancer Therapy Candidate in Patients with Newly Diagnosed Glioblastoma

MELBOURNE, Australia, Aug. 7, 2023 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today reveals that a very first client has actually been dosed in a Phase I research study of the Company’s investigational treatment TLX101 (4-L-[¹³¹I] iodo-phenylalanine, or ¹³¹I-IPA) in mix with post-surgical requirement of care treatment in clients with freshly detected glioblastoma, the most typical and aggressive form of main brain cancer.

IPAX-2 (ClinicalTrials.gov Identifier: NCT05450744) is a Phase I dosage escalation research study to validate safety profile of TLX101 in mix with external beam radiation treatment (EBRT) and temozolomide in front-line glioblastoma. Twelve clients are anticipated to be hired to examine whether the observed safety and drug interaction profile stays appropriate in this setting prior to advancing to a proof-of-concept Phase II research study.

IPAX-2 is being carried out at 6 websites throughout Australia, New Zealand and Europe. The research study will build on information created in IPAX-1 (ClinicalTrials.gov Identifier NCT03849105), which reported results in September 2022.^[1] The IPAX-1 research study satisfied its main unbiased showing safety and tolerability profile of intravenous ¹³¹I-IPA administered simultaneously with 2nd line EBRT. The research study likewise provided motivating initial healing impact, showing an average general survival of 13 months from the initiation of treatment in the repeating setting, or 23 months from preliminary medical diagnosis.

Professor Josef Pichler, Kepler University Hospital, Austria and Principal Investigator in the IPAX-2 research study said, “Promising effectiveness information observed in IPAX-1 plainly necessitates additional examination in an earlier setting. We are for that reason happy to be checking out Telix’s glioblastoma treatment prospect in freshly detected clients, to speed up advancement in this underserved illness location with couple of efficient treatment choices.”

Dr. Colin Hayward, Telix Chief Medical Officer included, “Commencing this research study supports Telix’s objective to speed up brand-new radiopharmaceutical treatments in locations of unmet requirement. With IPAX-2, we are taking the advancement of TLX101 into front-line glioblastoma for the very first time, and delighted to see the prospective effect of targeted radiation in clients after preliminary surgical treatment.”

Telix’s investigational positron emission tomography (FAMILY PET) representative TLX101-CDx (¹⁸F-FET) will be utilized for imaging in the research study to recognize individuals with over-expressed LAT-1 as appropriate prospects for ¹³¹I-IPA treatment, and to supply standard and follow up details on tumour reaction and development.

In parallel to IPAX-2, TLX101 is being even more examined in the frequent setting in the investigator-initiated Phase II IPAX-Linz research study, which dosed a very first client in November 2022^[2] and has actually now gone beyond 70% of the client enrolment target.

About TLX101

TLX101 (4-L-[¹³¹I] iodo-phenylalanine, or ¹³¹I-IPA) is among Telix’s lead healing medical programs and has actually been given orphan drug classification in the United States and Europe for glioblastoma treatment. TLX101 targets a membrane transportation protein called L-type amino acid transporter 1 (LAT-1) that is usually extremely revealed in glioblastoma. TLX101 is an unique technique that is easily able to travel through the blood-brain barrier, the typical protective barrier that avoids numerous prospective drug prospects going into the brain.

About TLX101-CDx (¹⁸F-FET)

¹⁸F-FET has actually been extensively utilized in medical research study settings while just recently, brand-new practice standards have actually been established for the imaging of gliomas utilizing animal with radiolabelled amino acids, of which ¹⁸F-FET is a crucial allowing radiopharmaceutical.^{[3] 18}F-FET targets the amino acid transportation system L (LAT) and is for that reason extremely appropriate for usage as a complementary diagnostic representative to TLX101. Telix is preparing to submit a brand-new drug application for TLX101-CDx with the United States Food and Drug Administration (FDA) throughout 2023, in preparation for U.S. business launch in 2024, pending regulative approval.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical business concentrated on the advancement and commercialisation of diagnostic and healing 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 attend to substantial unmet medical requirement in oncology and uncommon 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.

TLX101 and TLX101-CDx have actually not received a marketing authorisation in any jurisdiction. Telix’s lead item, gallium-68 (⁶⁸Ga) gozetotide (likewise referred to as ⁶⁸Ga PSMA-11) injection, has actually been authorized by the FDA,^[4] and by the Australian Therapeutic Goods Administration (TGA),^[5] and by Health Canada.^[6] Telix is likewise advancing marketing authorisation applications for this investigational prospect in the United Kingdom and the European Union.^[7]

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: [email protected]

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SOURCE Telix Pharmaceuticals Limited