SFX-01: Breast cancer
Evgen Pharma’s clinical plans in oncology have started with a Phase II trial (named STEM) in patients with ER+ metastatic breast cancer and will be led by principal 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 about 60 patients with ER+ metastatic breast cancer, will assess the potential reversal of resistance to hormone therapy and the impact on clinical benefit. The trial is designed to also create the opportunity to potentially stratify and help select patients best suited for treatment with SFX-01.
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 will be led by principal investigator Diederik Bulters at University Hospital Southampton, UK. The objective of SFX-01 therapy (co-administered with standard-of-care nimodipine) is to reduce the vasospasm and incidence of delayed cerebral ischemia (which can lead to cognitive impairment) in the days following the haemorrhage. This trial, which has been statistically powered to underpin a potential conditional market approval, represents a potentially faster route to early licence revenue.
Evgen Pharma has a preclinical SFX-01 programme in multiple sclerosis and a clinical interest in prostate cancer. Futhermore, preclinical data generated in collaboration with research establishments has confirmed the potential of SFX-01 in other major diseases.
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. Exploratory preclinical studies are currently under way to ascertain efficacy and safety of these new compounds.