Approval for Phase II Study in Breast Cancer

Evgen Pharma plc

 ("Evgen Pharma" or "the Company")

 Clinical Trial Approval for Phase II Study in Breast Cancer

Evgen Pharma plc (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, is pleased to announce 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."

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About Evgen Pharma plc

Evgen Pharma is a clinical stage drug development company whose lead programmes are in breast cancer and subarachnoid haemorrhage, a type of stroke. It is also carrying out preclinical work in multiple sclerosis and has a clinical interest in prostate cancer. The Company's core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. The lead product, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin. 

Evgen Pharma commenced operations in January 2008 and is based in Liverpool, UK, at the Liverpool Science Park.  It joined the AIM market of the London Stock Exchange in October 2015 and trades under the ticker symbol EVG.  For further information please visit www.evgen.com

About STEM

The official title of this Phase II trial is "STEM: A Multi-centre Phase 2 Study of SFX-01 Treatment and Evaluation in Patients with Estrogen Receptor (ER) Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer Progressing on either an Aromatase Inhibitor (AI) or Tamoxifen or Fulvestrant".

Up to 75% of all breast cancers are ER positive, and these cancers frequently develop resistance to hormonal therapies. The resistance has, in part, been attributed to the persistence of ER negative breast cancer stem cells. In preclinical models, SFX-01 has been shown to reduce (by up to 40%) the activity of breast cancer stem cells. Thus, SFX-01 may be a valuable therapy in preventing or reversing resistance to estrogen deprivation and anti-estrogens in ER positive breast cancers and thereby improving outcomes.

STEM is a Phase II 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.

The primary endpoints are to determine (a) the safety and tolerability of SFX-01 in combination with AI, tamoxifen and fulvestrant and (b) clinical benefit rate (CBR) at 24 weeks using RECIST v1.1. There are a number of secondary clinical endpoints and there will be exploratory analysis to identify populations that are more or less likely to respond to SFX-01 based on pharmacogenomics and tumour tissue or whole blood biomarker analyses.