Deflexifol offers a significant improvement to separate administration of 5FU and LV in the FOLFOX regimen. These standard of care drugs have annual sales currently exceeding $1billion. Deflexifol thus represents a strategic opportunity for a pharmaceutical company in the oncology injectables space.
Deflexifol IP comprises granted patents in the US, EU (validated in 5 countries), CN, CA and AU and a pending Indian patent application, all of which claim priority from PCT/AU2008/000276 (WO 2008/106721).A broad claimset covers compositions of matter, methods of manufacture and methods of treatment.FivePhusion Pty Ltd has exclusive worldwide rights to exploit Deflexifol IP, which is owned by the University of Wollongong.
As confirmed at a pre-IND meeting with the FDA, Deflexifol is suitable as a Section 505(b)(2) application for a Type 4 NDA submission. Marketing approval should be available after a Phase 2b trial.
A Phase 1b/2a clinical trial commenced patient treatment in December 2014. FivePhusion expects this trial to be completed early in 2015/6.
FivePhusion seeks to partner with a pharmaceutical company to further develop or licence Deflexifol for cancer applications.
Further information on trial results is available subject to a CDA, or please register your interest here for non confidential updates.