NH TherAguix Announces Continuation of the Phase II NANOBRAINMETS Trial in the Treatment of Brain Metastases after Completion of a Futility Analysis

  • The DSMB has approved the continuation of the study after the futility analysis performed on 50% of the total patient accrual.
  • No serious adverse events related to AGuIX® have been reported.
  • An interim efficacy analysis of AGuIX® in NANOBRAINMETS trial is expected by the end of 2024.
  • NANOBRAINMETS is a Phase II clinical trial, conducted in collaboration with the Dana Farber Cancer Institute, evaluating AGuIX® in patients with brain metastases in combination with stereotactic radiotherapy.

PARIS--()--NH TherAguix (NHT), a phase II clinical-stage biotechnology company specializing in the development of novel nanomedicine solutions for precision radiotherapy in oncology, today announced that the DSMB has validated the continuation of the Phase II trial, NANOBRAINMETS, managed by the Dana Farber Cancer Institute, following the futility analysis scheduled after the enrollment and follow up of 50% of patients in the study.

Ongoing evaluation of the study has revealed no serious adverse events related to the administration of AGuIX®, highlighting its very favorable safety profile. Developed by NHT, AGuIX® is designed to improve tumor targeting and increase radiobiological damage to tumor tissue locally.

96 patients have been randomized up to date on the 134 scheduled in the study’s protocol. Next interim analysis is currently expected by the end of 2024 to assess the clinical efficacy of AGuIX®.

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About NH TherAguix: www.nhtheraguix.com

NH TherAguix is a Phase 2 biotech company developing AGuIX®, an innovative nano drug to treat tumors and metastases in patients undergoing radiotherapy. Approximately 60% of cancer patients receive radiotherapy.

AGuIX®’s pharmacological properties and mode of action by bio-distribution allow it to enhance the radiotherapy precision and effectiveness in the heart of tumours conferring it a pan-cancer potential.

AGuIX® is currently being evaluated in multiple Phase II randomized trials across various cancer types such as brain metastases, glioblastoma, and pancreatic and lung cancers.

Over 200 patients have currently been treated with AGuIX® with an excellent safety profile and promising preliminary clinical results.

AGuIX® is protected by 18 patent families and has been extensively tested in various preclinical models, with results published in more than 80 high-impact, peer reviewed scientific publications.

Contacts

Contact
NH TherAguix
Vincent Carrère
contact@nhtheraguix.com

Medias Contact
NewCap
Arthur Rouillé
arouille@newcap.fr - +33 (0)1 44 71 00 15

Contacts

Contact
NH TherAguix
Vincent Carrère
contact@nhtheraguix.com

Medias Contact
NewCap
Arthur Rouillé
arouille@newcap.fr - +33 (0)1 44 71 00 15