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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.

Other programmes

Evgen Pharma supports a number of investigator-led preclinical studies on SFX-01 in multiple therapeutic areas.

Preclinical data relating to multiple sclerosis was presented at ECTRIMS 2016. The abstract can be accessed at this link and the associated poster at this link.

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.