First Patient Dosed in Breast Cancer Trial

RNS Number : 3010U

Evgen Pharma PLC

17 January 2017

 

For immediate release	17 January 2017

 

 

Evgen Pharma plc

 ("Evgen Pharma" or "the Company")

First Patient Dosed in Phase II Breast Cancer Trial

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 the first patient has been dosed in the Company's Phase II clinical trial of SFX-01 in breast cancer.

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.

Dr Stephen Franklin, CEO of Evgen Pharma, commented: "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."

Enquiries:

Evgen Pharma plc Dr Stephen Franklin, CEO www.evgen.com	c/o [phone]
Buchanan Mark Court, Sophie Cowles, Stephanie Watson		[phone]
Northland Capital Partners Limited Matthew Johnson, Gerry Beaney, Margarita Mitropoulou (Corporate Finance) John Howes, Rob Rees (Corporate Broking)		[phone]

Notes for editors:

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.

For a recent analyst research note on Evgen Pharma, please visit:

http://www.hardmanandco.com/docs/default-source/company-docs/evgen-pharma-documents/29.11.16-harnessing-the-clinical-potential-of-sulforaphane.pdf

 

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