#Australia #Melbourne #Telix Pharmaceuticals #TLX101 #Glioma

Promising Results from the IPAX-Linz Study on TLX101

Telix Pharmaceuticals Limited has disclosed the preliminary findings from the Phase 2 IPAX-Linz clinical trial, which investigates the efficacy of TLX101 (also known as 131I-iodofalan) in treating recurrent high-grade glioma, a serious form of brain cancer. This study aims to validate earlier results obtained from the IPAX-1 study and assesses the safety, tolerability, and early efficacy of TLX101 combined with external beam radiation therapy (EBRT).

Study Overview

The IPAX-Linz study is a single-arm, investigator-initiated trial focusing on patients experiencing their first or second recurrence of high-grade gliomas, including glioblastoma. Of the eight patients involved, treatment involved adaptive dosing of TLX101, administered intravenously at two different stages: before and after the EBRT procedure. The patient pool was characterized by a significant proportion with MGMT unmethylated tumors, which typically indicate poorer prognoses.

Results and Efficacy

The treatment with TLX101 was well tolerated among participants, with no serious adverse events reported. The median overall survival (OS) rate recorded was encouraging: 12.4 months after commencement of TLX101 therapy and 32.2 months from the date of initial diagnosis. These results align closely with findings from the earlier IPAX-1 study, which indicated a median OS of 13 months post-treatment initiation. Notably, this is a significant improvement compared to the typical 9.9 months median survival for glioblastoma patients who have undergone EBRT alone.

Principal Investigator's Insights

Professor Josef Pichler from Kepler University Hospital, who leads the IPAX-Linz study, commented on the findings, stating that the remarkable tolerability of TLX101, even in patients with challenging prognostic factors, illustrates its potential effectiveness in managing high-grade glioma. The initial positive signals from the previous studies appear to be reinforced by the current results, which allow for the possibility of exploring higher therapeutic doses in future studies.

Future Developments

Dr. David Cade, Chief Medical Officer at Telix, expressed optimism regarding the findings, emphasizing that these results open new avenues for improved patient outcomes where historically treatment options have been limited. The IPAX-Linz preliminary results are set to be presented by Professor Pichler at the Nuclear Medicine and Neurooncology Symposium scheduled for May 9-10, 2025, in Vienna, Austria.

Telix Pharmaceuticals is committed to further investigating TLX101's potential in glioma treatment across various patient settings. The company continues to recruit patients for the ongoing IPAX-2 study, which examines TLX101's effects in newly diagnosed glioblastoma cases. Moreover, an ethics approval has been sought for a registration-enabling study in relapsed glioblastoma, with patient enrollment expected to begin in the latter half of 2025, following successful FDA engagement.

Conclusion

TLX101 represents a promising advancement in glioma therapy, with preliminary findings indicating a notable increase in survival rates and a manageable side effect profile. These results could lead to a significant shift in the therapeutic landscape for patients battling this aggressive form of cancer, marking a hopeful turn in their treatment journey.