Clinical Trial Approval for Phase II Study in Breast Cancer
News Aug 18, 2016
Evgen Pharma plc has announced that it has received a Clinical Trial Approval (CTA) from the UK's regulatory agency for the commencement of its Phase II clinical trial of SFX-01 in breast cancer. Patient recruitment will begin in the UK at Manchester's Christie NHS Foundation Trust following Research Ethics approval, which is expected during the coming weeks. Further regulatory and Research Ethics approvals are also expected shortly at various sites across Europe in this multi-centre study.
The STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer) trial will investigate SFX-01 in combination with different hormone-based therapies in 60 metastatic breast cancer patients whose cancer cells are estrogen-receptor positive (ER+). The primary objectives of the STEM trial are to evaluate safety and efficacy (via tumour imaging) in patients starting to become resistant to mainstream hormone therapy. Patients will be enrolled into one of three study arms (SFX-01 in combination with either aromatase inhibitors, tamoxifen or fulvestrant) based on their current therapy.
One proposed mechanism for the generation of resistance to hormone therapy is via the proliferation of hormone-independent breast cancer stem cells. Such cells are known to proliferate during treatment with hormonal agents and it is thought they could have the effect of repopulating the tumour to render it hormone-independent. Earlier work by the Company with xenograft models suggests that SFX-01 has the effect of reducing the number of hormone-independent cancer stem cells.
The STEM trial will be led by Chief Investigator Dr Sacha Howell at Manchester's Christie NHS Foundation Trust, Europe's largest single-site cancer centre, and include several other sites across Europe. The first patient is expected to be recruited in October 2016. Evgen Pharma's SFX-01 is a synthetic and stabilised version of the naturally occurring plant compound sulforaphane, a known anti-cancer agent and neuro-protective.
Dr Stephen Franklin, CEO of Evgen Pharma, commented: "Many therapies used in cancer ultimately fail as patients develop resistance - one hypothesis is that this resistance is driven by cancer stem cells which, unlike a mature cancer cell, do not respond to current standards of care. Our excitement with SFX-01 is that it targets the cancer stem cell population and therefore has the potential to improve the efficacy and longevity of a range of drugs used in cancer therapy - both approved drugs and those in clinical development. I would also like to take this opportunity to thank Dr Sacha Howell and colleagues at the Christie NHS Foundation Trust and the Cancer Research UK Manchester Institute for their steadfast support and encouragement."