Evgen Pharma Regulatory News (EVG)

14 June 2021

Evgen Pharma plc

 ("Evgen" or the "Company")

Progress with Glioma/Glioblastoma programme

Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces further progress and an update on clinical trial plans for SFX-01 in glioblastoma ("GBM").

Glioma is the most common form of brain tumour affecting around 5 per 100,000 people. The more severe, grade IV classification, glioblastoma, is a very serious form of brain tumour representing 45% of all cases and has a poor prognosis with median survival of around 14 months. Together with neuroblastoma, GBMs now account for more deaths in the under 40s than any other tumour.

Previously the Company reported that these data generated by Dr Claudio Festuccia at University L'Aquila showed that with in vivo pre-clinical subcutaneous and orthotopic models (where glioma cells are implanted in brain tissue representing a more disease-relevant model), SFX-01 produced tumour shrinkage and significantly extended survival times. SFX-01 was also found to potentiate (i.e. substantially increase) the therapeutic effect of radiotherapy in these models.

Evgen now report that the in vitro these data from these experiments have been reproduced with very similar results at the University of Auckland using cells generated from freshly extracted patient GBM tissue, rather than the standard GBM cell lines established many decades previously. Further in vivo work has commenced at a contract research organisation to build upon the subcutaneous GBM tumour model experiments conducted by Dr Festuccia.

Plans for a Phase II GBM clinical trial with an adaptive design are progressing with a scheduled start in the first half of 2022. In tandem work has started with regulatory advisers on preparation of an Investigational New Drug application for submission to the US Food and Drug Administration in Q4/2021.

The therapeutic options for GBM are limited to surgery, radiotherapy and the one drug widely available, temozolomide. There is a clear unmet need for more treatments for use in conjunction with the current standard of care.

Dr Huw Jones, Evgen CEO, commented: "Building on this data set generated by Dr Festuccia is a key step in the pathway to commencement of a clinical trial, and we are delighted that the work done at Auckland University has produced such consistent positive results. We are excited by this compelling new data set in a type of cancer which has severely limited therapeutic options for the patient and thank Professor Bruce Baguley and Dr Euphemia Leung for their advice and insightful experiments. We have started the planning for the Phase II trial and are pleased to report the GBM programme is proceeding exactly to plan."

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About Evgen Pharma plc

Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. 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.

Clinical data from the Company's open-label Phase II STEM trial has shown that SFX-01 can halt the growth of progressing tumours in patients with oestrogen-positive (ER+) metastatic breast cancer, and in some cases significantly shrink the tumour, whilst causing very few side effects.

The Company has its headquarters at Alderley Park, Cheshire, and its registered office is at the Liverpool Science Park, Liverpool. It is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol EVG.  

For further information, please visit: www.evgen.com

For research on the Company, please visit: http://evgen.com/investors/analyst-coverage/