Evgen Pharma Plc (LON:EVG) CEO Dr Stephen Franklin talks to DirectorsTalk about it’s latest interim statement. Stephen reminds us what SFX-01 is and what diseases they are targeting, runs through the main headlines from the interim statement.
Evgen Pharma Plc was founded in 2007 by Dr Stephen Franklin in collaboration with two venture capital investors (Enterprise Ventures and Imprimatur Capital), with the strategic objective of securing intellectual property rights relating to natural products that could have a disruptive impact in healthcare. First funding was secured in 2008. After in-depth evaluation of a number of diverse opportunities, management secured the intellectual property rights to the Sulforadex technology from PharmAgra Labs in 2010 and 2011, via an exclusive option then exclusive worldwide licence, respectively. This technology enabled, for the first time, the manufacture of a synthetic and stabilised form of the natural product, sulforaphane.
Sulforaphane is produced by enzymatic degradation of glucoraphanin in cruciferous vegetables, such as the brassica family (broccoli, cabbage, sprouts etc.), in response to damage – e.g. insect attack or chewing by animals. Interest in sulforaphane has been intense since it was discovered in 1992 to have anti-cancer properties. Since then, there have been over 1,500 scientific research publications and several clinical trials using frozen botanical extracts. However, although sulforaphane can be manufactured synthetically, it is an incredibly unstable chemical that needs to be stored at –20°C under an inert atmosphere, making it unsuitable for use as a drug.
Sulforadex is the technology that overcomes this considerable disadvantage. Synthetic sulforaphane is encapsulated within a sugar ring structure, called α-cyclodextrin, to create a viable formulation that is stable at ambient temperature.
Since inception, Evgen has raised £13m, using the proceeds for pre-clinical development work and to undertake clinical trials. Evgen has conducted two Phase I clinical studies that established the safety and tolerability profile of SFX-01 in healthy subjects. The first study used a single ascending dose regimen which resulted in minor side effects (gastric irritation and nausea) and identified the Maximum Tolerated Dose. These findings allowed Evgen to optimise the dosing regimen by splitting the dose into a twice-daily administration of 300mg of SFX-01. In the second trial, these improvements eliminated the side-effects.