Deflexifol (5-fluorouracil/leucovorin) / FivepHusion - LARVOL DELTA

DART (Deflexifol At Relapse Trial): Phase II Trial of Deflexifol for Refractory or Recurrent Paediatric Central Nervous System (CNS) Tumours (ANZCTR) - P2 | N=10 | Not yet recruiting | Sponsor: Australian and New Zealand Children’s Haematology and Oncology Group (ANZCHOG)

New P2 trial • Brain Cancer • CNS Tumor • Ependymoma • Oncology • Pediatrics • Solid Tumor

A Phase 1 trial of Deflexifol™ in pediatric patients with relapsed or refractory brain tumors (SNO 2025) - "BACKGROUND Deflexifol is a novel combination of 5-fluorouracil (5-FU) and leucovorin, allowing for co-delivery in one infusion...This study has demonstrated that Deflexifol is well tolerated in children. A Phase 2 expansion cohort is planned to evaluate the activity of Deflexifol in children with ependymoma."

Clinical • P1 data • Brain Cancer • Dermatology • Ependymoma • Febrile Neutropenia • Hematological Disorders • Leukopenia • Mucositis • Neutropenia • Oncology • Pediatrics • Solid Tumor • Stomatitis

A Phase 1 trial of Deflexifol™ in pediatric patients with relapsed or refractory brain tumors (WFNOS 2025) - "BACKGROUND Deflexifol is a novel combination of 5-fluorouracil (5-FU) and leucovorin, allowing for co-delivery in one infusion...This study has demonstrated that Deflexifol is well tolerated in children. A Phase 2 expansion cohort is planned to evaluate the activity of Deflexifol in children with ependymoma."

Clinical • P1 data • Brain Cancer • Dermatology • Ependymoma • Febrile Neutropenia • Hematological Disorders • Leukopenia • Mucositis • Neutropenia • Pediatrics • Solid Tumor • Stomatitis

A phase I dose-escalation study of an all-in-one 5-fluorouracil and leucovorin co-formulation administered after failure of standard treatment. (ASCO-GI 2024) - "Deflexifol is safe and well tolerated at doses of 5-FU up to 40% higher than typically administered by the standard modified de Gramont regimen. 5-FU and LV co-exposure extended throughout the entire dosing period, substantially longer than reported for standard treatment. Disease control was achieved in 69% of patients."

P1 data • Colorectal Cancer • Gastrointestinal Cancer

Phase I Trial of Deflexifol for Refractory or Recurrent Paediatric Central Nervous System (CNS) Tumours (ANZCTR) - P1 | N=24 | Recruiting | Sponsor: Australian and New Zealand Children’s Haematology and Oncology Group (ANZCHOG) | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2023

Enrollment open • Trial initiation date • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Diffuse Midline Glioma • Ependymoma • Glioma • Oncology • Pediatrics • Solid Tumor

Allarity Therapeutics and FivepHusion Announce Collaboration to Support Clinical Development of Deflexifol with DRP Companion Diagnostics (GlobeNewswire) - "Allarity Therapeutics, Inc...and Detsamma Investments Pty. Ltd. trading as 'FivepHusion,'...developing Deflexifol™...announced today that the two companies have entered into a Clinical Collaboration Agreement. Under this agreement, Allarity will support FivepHusion’s future clinical development of Deflexifol™ for the treatment of solid tumors by using certain of Allarity’s drug-specific DRP® companion diagnostics, including its validated DRP®-5FU companion diagnostic, to potentially select patients for enrollment and treatment in clinical trials of Deflexifol™ as a monotherapy and in combination with other drugs....FivepHusion expects to start a phase 1b/2a study investigating Deflexifol™ in combination with oxaliplatin ('DEFLOX') and bevacizumab in the 1st line treatment of unresectable metastatic colorectal cancer (mCRC) patients in H2 2023."

Companion diagnostic • Licensing / partnership • New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor