Final IPAX-1 Study Data Confirms Safety and Tolerability Profile for TLX101, Preliminary Efficacy Data – QNT Press Release

MELBOURNE, Australia, Sept. 20, 2022 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today reports the final results from the IPAX-1 Ph I/II study of TLX101 therapy (4-L-[ 131I] iodo-phenylalanine, or 131I-IPA) in combination with external beam radiation therapy (EBRT) in recurrent glioblastoma multiforme (GBM).

The primary objective of the IPAX-1 study was to evaluate the safety and tolerability profile of intravenous 131I-IPA administered concurrently with second line EBRT in patients with recurrent GBM. Secondary objectives were to determine optimal dosing, biodistribution and radiation absorption into the tumour, as well as assess preliminary efficacy through clinical and imaging-based assessment of tumour response.

Final data up to the completion of the post-study follow-up period confirms the study has met its primary objective, demonstrating the safety and tolerability profile of TLX101 at the dosing range tested. The study also delivered encouraging preliminary efficacy data for further evaluation, demonstrating a median overall survival (OS) of 13 months from the initiation of treatment in the recurring setting, or 23 months from initial diagnosis. Given that GBM has a median survival from initial diagnosis of 12-15 months, the overall survival improvement trend seen in this patient population clearly warrants further evaluation in a larger patient population.

Recurrent GBM is a highly aggressive cancer that progresses rapidly, and for which there are few effective treatment options. TLX101 is a systemically administered targeted radiation therapy that targets L-type amino acid transporter 1 (LAT-1), which is typically over-expressed in GBM. TLX101 has been granted orphan drug designation in the United States and Europe.

IPAX-1 Results Summary

10 patients were enrolled of whom 9 received the full study treatment dosing of ~2GBq (2000 MBq) of TLX101, either in the form of a single administration or one of two triple-fractionated regimens. The results demonstrated all dosing regimens, in combination with EBRT, were well tolerated:

  • Dosimetric analysis demonstrates that radiation exposure to key organs is well within acceptable safety limits.
  • The most frequent treatment emergent adverse…

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