Telix Pharmaceuticals Reports Promising Results in Phase 2 Brain Cancer Study

Telix Pharmaceuticals, an Australian biotech company, has announced encouraging results from its phase 2 Ipax-Linz trial, evaluating the efficacy of its radiation therapy TLX101 in patients with recurrent high-grade glioma. The study, which combined TLX101 with external beam radiation therapy (EBRT), demonstrated a median overall survival (OS) rate of 12.4 months from the initiation of treatment.

Trial Details and Key Findings

The Ipax-Linz trial enrolled eight patients with recurrent high-grade glioma, focusing primarily on safety and tolerability. Telix reported that the treatment was well-tolerated, with no serious adverse events observed. Patients received adaptive intravenous dosing of TLX101, a radiation therapy targeting the L-type amino acid transporter (LAT1), in combination with EBRT.

Secondary endpoints of the study revealed promising survival data:

• Median OS of 12.4 months from the initiation of TLX101 treatment
• Median OS of 32.2 months from initial diagnosis
• Consistency with the 13-month median OS observed in the previous Ipax-1 study

These results are particularly notable when compared to the historical median survival of 9.9 months for patients with recurrent glioblastoma receiving EBRT alone.

Expert Commentary and Future Directions

Dr. Josef Pichler, principal investigator from Kepler University Hospital in Austria, emphasized the significance of the results, stating, "TLX101 treatment was very well tolerated, with no serious adverse events, at a higher dose than in previous studies." He also noted that the efficacy was corroborated despite five of the eight patients having MGMT unmethylated tumors, which typically correlate with poor outcomes.

Telix's Chief Medical Officer, David Cade, expressed optimism about the findings, suggesting that these "encouraging results offer new options for patients with historically poor outcomes."

Looking ahead, Telix plans to focus on controlled studies to further evaluate TLX101's efficacy and explore the potential for higher therapeutic doses. The company aims to build on these promising results as it seeks to advance the treatment towards potential regulatory approval.