23 March 2022 | News
TLX101 is one of the Company's lead therapeutic clinical programs and has been granted orphan drug designation in the US and Europe
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Telix Pharmaceuticals announces it has made significant progress in advancing the Company's glioblastoma multiforme (GBM) therapy candidate TLX101 into the next stage of clinical development.
TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA) is one of the Company's lead therapeutic clinical programs and has been granted orphan drug designation in the US and Europe. TLX101 targets L-type amino acid transporter 1 (LAT-1), typically over-expressed in GBM.
The IPAX-1 Phase I study, which completed recruitment in 2021, established a favourable safety profile for TLX101 and promising preliminary disease stabilisation with evidence of anti-tumour responses in a second-line (refractory) disease setting.
Building on this experience, Telix has now been granted Human Research Ethics Committee (HREC) approval to commence a Phase I dose escalation study (called "IPAX-2") to evaluate TLX101 in combination with post-surgical standard of care comprised of external beam radiation therapy (EBRT) and temozolomide in newly diagnosed GBM patients. Twelve patients are expected to be recruited to evaluate whether the observed safety and drug interaction profile remains suitable in this setting before progressing to a Phase II study.