Telix Prescribed drugs Restricted TLX on Tuesday launched preliminary outcomes from the Part 2 IPAX-Linz research of TLX101 (131I-iodofalan1) in recurrent high-grade glioma (mind most cancers), substantiating the affected person profit seen within the IPAX-1 research.
IPAX-Linz is a single-arm Part 2 investigator-initiated trial evaluating the protection, tolerability, and preliminary efficacy of TLX101 remedy together with exterior beam radiation remedy (EBRT).
TLX101 (131I-iodofalan or 131I-IPA) is a systemically administered focused radiation remedy that targets L-type amino acid transporter 1, which is usually over-expressed in glioblastoma.
The goal affected person inhabitants is sufferers at first or second recurrence with high-grade gliomas (HGG), together with glioblastoma.
Therapy with TLX101 was properly tolerated, with no severe antagonistic occasions reported.
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IPAX-Linz demonstrated encouraging preliminary efficacy knowledge, indicating a median total survival (OS) of 12.4 months from the initiation of therapy with TLX101 or 32.2 months from the preliminary analysis.
That is in keeping with the constructive efficacy sign generated within the IPAX-1 research in sufferers at first recurrence, with just one prior resection and therapy with normal chemoradiotherapy.
IPAX-1 reported a median OS of 13 months from the initiation of therapy with TLX101 or 23 months from the preliminary analysis.
Compared, recurrent glioblastoma sufferers handled with EBRT alone have a reported median survival of 9.9 months from therapy.
Eight sufferers had been included within the research with adaptive dosing of intravenous TLX101 as much as the administered exercise of 4 GBq earlier than and as much as 2 GBq after second-line EBRT, administered in sequential injections.
Preliminary outcomes from IPAX-Linz will probably be offered on the Nuclear Medication and Neurooncology (NMN) Symposium, which is able to happen in Might.
Telix continues to research TLX101 in front-line and recurrent settings. IPAX-2, a Part 1/2 research in front-line glioblastoma together with normal of care and utilizing TLX101-CDx as a companion diagnostic, continues to recruit sufferers.
Telix has submitted for ethics approval a registration-enabling research of TLX101 in recurrent glioblastoma.
Topic to approval, this may allow affected person enrollment to begin at Australian websites in H2 2025, forward of worldwide enlargement.
Following the profitable pre-IND assembly with the U.S. Meals and Drug Administration (FDA) in This autumn 2024, the corporate can also be on observe to submit an IND utility in H1 2025 to begin the research at U.S. websites in H2 2025.
Professor Josef Pichler, Kepler College Hospital, Austria, Principal Investigator, commented, “These preliminary ends in relapsed sufferers confirmed that TLX101 therapy was very properly tolerated, with no severe antagonistic occasions, at the next dose than in earlier research. Early efficacy from IPAX-1 was corroborated regardless of the poor prognostic parameters with MGMT unmethylated tumors and a number of relapses earlier than commencing experimental remedy on this IPAX-Linz research. TLX101 continues to indicate vital potential to enhance outcomes for sufferers dwelling with high-grade glioma. These outcomes additionally doubtlessly help increased therapeutic doses in subsequent potential managed research.”
William Blair writes, “We’re intrigued by the general survival knowledge generated from the Part II IPAX-Linz research of TLX101, and we imagine it warrants additional investigation. The info additionally corroborated the outcomes generated from Part I IPAX-1 research, which demonstrated a median survival of roughly 12 to 13 months and seem like numerically longer than recurrent glioblastoma sufferers receiving solely exterior beam radiation remedy (roughly 10 months).”
“From a inventory perspective, we proceed to carry a bullish view on Telix shares,” analyst Andy Hsieh writes.
Value Motion: TLX inventory is down 0.30% at $16.77 on the final examine Wednesday.
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