SFX-01: Breast cancer (Status: Phase IIb ready)
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.
In March 2019, Evgen Pharma announced positive results from the open-label Phase II STEM trial of SFX-01 in 46 patients with oestrogen-positive metastatic breast cancer. The headlines were:
i) Conclusive evidence of anti-cancer activity via objective responses (tumour shrinkage)
ii) 24% of patients showed a durable clinical benefit for at least six months, despite the late stage of disease and patients’ established resistance to hormone therapy. Of these, five patients were still receiving SFX-01 at 12 months and one patient still remains on treatment after 18 months (as of 17 December 2019)
iii) A mild and favourable side effect profile for an anti-cancer drug.
All STEM patients had ER+ metastatic breast cancer and had previously received treatment with either tamoxifen, aromatase inhibitors (AI) or fulvestrant. Prior to entry to the STEM trial, patients must have previously responded to their current hormone therapy for at least six months but then present with progressive disease, thereby demonstrating the start of resistance to the hormone therapy. Once entered into the trial, patients continued to receive their failing hormone therapy in addition to SFX-01 and have regular scans through to week 24. Patients discontinued the trial when one of the scans shows disease progression, or at week 24. Those patients who did not progress by week 24 were allowed to continue to receive treatment in an extension phase until disease progression.
POSTERS AND PRESENTATIONS
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.
The STEM results as presented by poster at ESMO on 29 September 2019 can be viewed here.
SFX-01: Other clinical programmes (Status: Phase II ready)
Evgen Pharma has announced that it has entered into MoUs to support investigator-led trials in:
I) Autism at Guy’s and St Thomas’ NHS Foundation Trust, London, UK
II) NASH at the University of Dundee, UK
The respective investigators and their institutions are currently preparing for these trials and in the process of seeking grant funding.
SFX-01: Preclinical programmes
Evgen Pharma also supports a number of investigator-led preclinical studies on SFX-01 in other therapeutic areas. In addition, our own 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, Evgen Pharma also holds the exclusive world-wide rights to a range of novel sulforaphane analogues developed by the medicinal chemistry group at the University of Seville in Spain. These compounds are in preclinical investigation.