Deflexifol offers a significant improvement to separate administration of 5-FU and LV in the FOLFOX regimen. The metastatic colorectal cancer market alone has worldwide annual sales currently exceeding US$12.7 billion. 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, AU and India, all of which claim priority from PCT/AU2008/000276 (WO 2008/106721). A broad claim set covers compositions of matter, methods of manufacture and methods of treatment. Data exclusivities in major markets will extend protection to >2030. FivepHusion has exclusive worldwide rights to exploit Deflexifol IP.
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 pivotal trial.
A Phase 1b/2a clinical trial completed patient treatment in 2017 with promising results, including significantly increased safety and strong signals of improved efficacy. These results are also reflected in the current bridging trial.
FivepHusion seeks to out-license or 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.