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news.Evgen Pharma has dosed the first patient in its Phase II clinical trial of SFX-01 in breast cancer.
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The STEM (SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer) trial is investigating 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 is being led by Chief Investigator Dr Sacha Howell at Manchester's Christie NHS Foundation Trust, Europe's largest single-site cancer centre, and will include approximately 15 sites in 5 countries.
The first patient was dosed on 16 January 2017 at the Cliniques universitaires Saint-Luc, the largest hospital in Brussels, Belgium.
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.
SFX-01 is a synthetic and stabilised version of the naturally occurring plant compound sulforaphane, a known anti-cancer agent and neuro-protective.
Evgen Pharma CEO Dr Stephen Franklin said: "The first patient being dosed in this Phase II trial of SFX-01 in breast cancer is another major milestone for Evgen Pharma.
“We would like to thank all of the investigators and sites participating in this exciting trial, which is seeking to demonstrate that SFX-01 is safe, well tolerated and can positively impact the resistance to hormone-based therapy in metastatic breast cancer patients."