MELBOURNE, Australia and LONDON, Aug. 17, 2021 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces today that London-based Great Ormond Street Hospital (GOSH) has obtained UK ethics approval for research to initiate a Phase II academic study of Telix’s investigational product, TLX66 (90Y-DTPA-besilesomab), in children with high-risk leukemia. Relevant approvals from the Medicines and Healthcare products Regulatory Agency (MHRA) and the Administration of Radioactive Substances Advisory Committee (ARSAC) have also been received. The study is independently funded through the generosity of a philanthropic foundation, sponsored by GOSH.
The open-label Phase II study is being conducted by GOSH to evaluate the safety and efficacy of TLX66 as part of a reduced toxicity conditioning regimen in children and adolescents undergoing allogeneic hematopoietic stem cell transplantation (HSCT). The independent study will enroll 25 patients and follows the successful completion of a Phase I study1 of 10 patients with relapsed refractory leukemia. TLX66 targets CD662, a receptor expressed on specific types of immune/blood cells and has received orphan drug designation (ODD) status in Europe for bone marrow conditioning (BMC) for hematopoietic stem cell transplantation (HSCT), a broad clinical indication .
In addition to pediatric leukemia, previous phase I3 and II4 clinical studies of TLX66 have shown encouraging efficacy and safety data in multiple myeloma and in patients with other haematological malignancies who are currently ineligible for stem cell transplantation due to toxicity. Telix recently reported positive topline results from the TRALA study5 of TLX66 at the University of Southampton (UK) for patients with systemic amyloid light chain amyloidosis (SALA), a rare disease with a poor prognosis characterized by abnormal protein deposition in the organs of the body.
dr. Colin Hayward, Telix’s Chief Medical Officer, said: “We are pleased that Great Ormond Street Hospital, an international center of excellence in pediatric health care, has received ethical approval to use this research product in an important academic study in children and adolescents with high This disease currently has one of the worst prognosis among pediatric cancers, and we will closely monitor the progress of the GOSH team, consistent with Telix’s mission to help patients with cancer live longer and better lives. “
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on developing diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia, with international operations in Belgium, Japan and the United States. Telix is developing a portfolio of clinical-stage products that address a significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX:TLX). For more information, visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.
Telix’s lead investigational product, illuccix® (TLX591-CDx) for prostate cancer imaging, has been accepted for application by the US FDA6 and is under priority review by the Australian Therapeutic Goods Administration (TGA).7 Telix is also seeking authorization to marketing applications for illuccix® in the European Union8 and Canada.9 None of Telix’s products has received a marketing authorization in any jurisdiction.
Telix media contact
dr. Stewart Holmstrom
Telix Pharmaceuticals Limited
Director Corporate Communication
1 Full results of the Phase I trial are expected to be published by the end of 2021.
2 Cluster of differentiation 66.
3 ClinicalTrials.gov Identifier: NCT01521611.
4 ClinicalTrials.gov Identifier: NCT00637767.
5 ASX disclosure 25/05/21.
6 ASX Disclosure 24/11/20.
7 ASX disclosure 14/04/21.
8 ASX disclosure 1/05/20.
9 ASX Disclosure 16/12/20.