FivepHusion today announces important progress in its ongoing FP101A phase 1b/2a dose-escalation clinical study of Deflexifol™ in patients with advanced solid tumours: Deflexifol™ is an optimised all-in-one formulation of the chemotherapeutic agents 5-fluorouracil (5-FU) and leucovorin (LV) for the treatment of solid tumours The ongoing FP101A phase 1b/2a clinical study is designed to confirm the […]
FivepHusion today announces the establishment of an independent, expert Clinical Advisory Board (CAB) comprising some of Australia’s leading clinical experts in oncology and pharmacology. The board will advise and guide our company on the ongoing development of Deflexifol™, an optimised formulation of the chemotherapeutic agents 5-fluoruracil (5-FU) and leucovorin (LV) for the treatment of solid […]
The bridging PK study of Deflexifol is progressing well. Study chief investigator Associate Professor Daniel Brungs reports that patients are now expected to be recruited to Dose Level 4, subject to approval by the Independent Data Safety Monitor. 14 patients have been treated so far, including 4 at Dose Level 3 without any SAEs. The […]
FivepHusion will be attending and presenting at BIO Digital 2021, on June 14-18. As it prepares for its phase III pivotal registration trial, FivepHusion is seeking investment and strategic partners to pursue registration and commercialisation of Deflexifol™ as the new standard of care for solid tumor treatment.
The bridging PK study of Deflexifol is reported to be progressing well. Sponsored by Detsamma Investments under an out-license from FivepHusion, the clinical trial is being undertaken at the Southern Medical Day Care Centre in Wollongong, Australia. Study chief investigator Associate Professor Daniel Brungs reports that patients are still being recruited to Dose Level 2, […]
Fivephusion has concluded a drug development partnership deal with Detsamma Investments Pty Ltd. Detsamma will fund the further development of Deflexifol, including completing a bridging trial to gather extra data sought by the FDA. Detsamma Investments plans to complete the bridging trial in 2020, and follow this with a pre-IND meeting with the FDA. Detsamma […]
FivepHusion have engaged Bio-Link Australia to assist with business development and out-licensing opportunities for Deflexifol. Bio-Link (http://bio-link.com/) is a strategic consulting and biotechnology business development company that works with Australian and international life sciences companies and academic institutions to facilitate deals based on strategic technology analysis and consulting, business development, project management and deal negotiation.
The phase 1 trial results were presented in greater detail in two posters at ASCO 2017 in Chicago this week. Professor Phil Clingan presented a poster: Deflexifol (a novel formulation of 5FU) Phase 1 Dose Escalation Study of Infusional or Bolus Schedules After Failure of Standard Treatment Clingan P. et al J Clin Oncol 35, 2017 […]