Evgen Pharma plc Clinical trials progress alongside advances in sulforaphane science

Evgen Pharma Plc
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Evgen Pharma plc (LON:EVG), the clinical stage drug development company focused on cancer and neurological conditions, announces its unaudited interim results for the six months ended 30 September 2017.

Highlights in the year to date:

· Good progress in the Company’s Phase II metastatic breast cancer clinical trial (‘STEM’) of SFX-01, the Company’s lead product. Seven sites open for recruitment across UK, Belgium and Spain. On track to report in second half of 2018 with interim read-out in H1 2018

– Compassionate use programme commenced in STEM for patients whose disease progression was arrested during the full 24-week period of the trial

– Elucidation of potential mechanism of action for SFX-01 in breast cancer

· Phase II subarachnoid haemorrhage stroke trial (‘SAS’) of SFX-01 on track to report around the end of 2018

– Site initiation completed at Birmingham with a further three sites under consideration

· First patent grant in Europe for SFX-01, relating to manufacturing and scale-up processes

· Study of SFX-01 on patient-derived tumours from triple negative breast cancer patients (in a xenograft model) to commence at the Manchester Cancer Research Centre funded by the Shine Bright Foundation

· Financial performance in-line with expectations:

– Total comprehensive loss of £1.7m (30 September 2016: loss of £1.7m)

– Net cash outflow (before short-term investment movements) of £1.7m (30 September 2016: £1.6m)

– Cash and short-term investments and cash on deposit at 30 September 2017 of £2.2m (30 September 2016: £5.5m)

Stephen Franklin, Chief Executive Officer of Evgen Pharma Plc, said: “We are particularly pleased with the progress of the STEM trial and the requirement to open the compassionate use programme for patients that have had their tumour growth arrested for the full duration of the 24-week trial and wish to receive SFX-01 post-trial on ethical grounds. We now have one STEM patient that has been on SFX-01 for nearly a year with demonstrable clinical benefit and others that have entered the compassionate use programme.

“We are also most encouraged by the results that are starting to emerge from our research collaborators at the University of Manchester that cast new light on how SFX-01 may be working mechanistically in advanced breast cancer. This work, which will be published next year, has demonstrated that SFX-01 near eliminates the activated form of a protein, called STAT3, that is elevated in tumours that have become resistant to hormone therapy. STAT3 is known to play a key role in promoting tumour renewal, metastases and helping some cancers evade the surveillance of the immune system.”

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