SFX-01: Breast cancer
Evgen Pharma’s clinical plans in oncology started with a Phase II trial (named STEM) in patients with ER+ metastatic breast cancer led by chief investigator Dr Sacha Howell at the Christie NHS Foundation Trust (Europe’s largest single-site cancer centre) and conducted at a number of other sites across Europe. The trial, in 46 patients with ER+ metastatic breast cancer, assessed the potential reversal of resistance to hormone therapy and the impact on clinical benefit. The trial successfully met its primary endpoints.
A poster entitled “SFX-01 targets STAT3 signalling to inhibit stem-like cells in breast cancer patient-derived xenograft tumours“, presented at the UK Interdisciplinary Breast Cancer Symposium 2018, can be viewed here.
A poster entitled “STEM: SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer“, presented at the San Antonio Breast Cancer Symposium 2018, can be viewed here.
A poster entitled “Novel biomarkers for sulforaphane treated patients in ER+/HER- metastatic breast cancer” presented at ABPP 2019, can be viewed here.
The STEM Headline Results presentation from 25 March 2019 can be viewed here.
SFX-01: Subarachnoid haemorrhage
Evgen Pharma’s clinical plans in neurology have started with a Phase II trial (named SAS) in patients that have had a type of stroke called a subarachnoid haemorrhage and is being led by principal investigator Diederik Bulters at University Hospital Southampton, UK. The objective of the SFX-01 therapy (co-administered with standard-of-care, nimodipine) is to reduce the vasospasm and incidence of delayed cerebral ischaemia (which can lead to cognitive impairment) in the days following the haemorrhage. The US Food & Drug Administration (“FDA”) has granted Evgen orphan drug designation for the use of stabilised sulforaphane for the treatment of subarachnoid haemorrhage.
Evgen Pharma supports a number of investigator-led preclinical studies on SFX-01 in multiple therapeutic areas.
Finally, the company also has access to a range of novel sulforaphane analogues developed by the medicinal chemistry group at the University of Seville in Spain.