Date: 2016-08-16
Type of information: Clinical trial autorization
phase: 1-2
Announcement: clinical trial authorization
Company: Evgen Pharma (UK)
Product: SFX-01
Action
mechanism: neuroprotective agent. SFX-01 is a synthetic version of sulforaphane, a known neuroprotective and anti-cancer agent, which is stabilised in a novel patented complex using a proprietary manufacturing process. SFX-01 potentially represents a new class of drug in aneurysmal SAH with a mechanism of action that specifically targets the Nrf-2 pathway, which in turn reduces the oxidative stress and the toxicity caused by free hemoglobin from the haemorrhage. 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 Evgen Pharma with xenograft models suggests that SFX-01 has the effect of reducing the number of hormone-independent cancer stem cells.
Disease: breast cancer
Therapeutic area: Cancer - Oncology
Country: Belgium, Czech Republic, France, Spain, UK
Trial
details: STEM is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant. Patients will be enrolled into one of three study arms (SFX-01 in combination with AI, tamoxifen or fulvestrant) based on their current therapy. (NCT02970682)
Latest
news: * On August 17, 2016, Evgen Pharma 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. 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.
