SFX-01: Breast cancer (Status: Phase IIb ready)
Evgen Pharma’s clinical plans in oncology started with a Phase II trial [STEM – SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer] 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 received SFX-01 for over 12 months and one patient remained on treatment for over 18 months.
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: Acute Respiratory Distress Syndrome (‘ARDS’) – Phase IIb/III
Patient recruitment commenced in early December 2020 on the STAR trial. This Phase IIb/III trial is a randomised, placebo-controlled trial and is sponsored by the University of Dundee. It will investigate whether the Company’s lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome ARDS in patients with community-acquired pneumonia who have been or are being tested for suspected COVID-19. Patients may therefore present with COVID-19 or other respiratory diseases. The trial is being funded by the LifeArc medical charity following a very competitive application process.
SFX-01: Pre-clinical programmes
Strong pre-clinical data has been generated in a new solid tumour indication, glioma/glioblastoma with further pre-clinical work underway and designs for a Phase Ib/IIa trial being assessed.
Pre-clinical work has also commenced in a blood cancer indication based on new evidence that SFX-01 inhibits the SHP2 pathway. Other cancers where the SHP2 pathway is implicated are being assessed.
Evgen Pharma also supports a number of other investigator-led pre-clinical studies on SFX-01 in other therapeutic areas.
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.