Evgen Pharma PLC Progress with Glioma/Glioblastoma programme (7157B)
14 Junio 2021 - 01:00AM
UK Regulatory
TIDMEVG
RNS Number : 7157B
Evgen Pharma PLC
14 June 2021
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."
Enquiries:
Evgen Pharma plc www.evgen.com via Walbrook
Dr Huw Jones, CEO
Richard Moulson, CFO
finnCap www.finncap.com +44 (0)20 7220 0500
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane (ECM)
Walbrook PR +44 (0)20 7933 87870 or evgen@walbrookpr.com
+44 (0)7876 741 001 / +44 (0)7980
Anna Dunphy / Paul McManus 541 893
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(R),
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/
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