Evgen Pharma PLC Agreement for supply of SFX-01 for autism trial (2509L)
05 Settembre 2019 - 8:00AM
UK Regulatory
TIDMEVG
RNS Number : 2509L
Evgen Pharma PLC
05 September 2019
Evgen Pharma plc
("Evgen" or the "Company")
Agreement for supply of SFX-01 for autism clinical trial
Guy's and St Thomas' NHS Foundation Trust prepare to lead Phase
II trial
Evgen Pharma (AIM: EVG), a clinical stage drug development
company focused on the treatment of cancer and neurological
conditions, announces that it has entered into a Memorandum of
Understanding with Guy's and St Thomas' NHS Foundation Trust
("Guy's and St Thomas'") to advance the Company's lead compound
SFX-01, towards a clinical trial in patients diagnosed with Autism
Spectrum Disorder ("ASD").
SFX-01, is the Company's lead product and contains a stabilised
synthetic sulforaphane molecule. Sulforaphane, within a botanical
extract, has previously been demonstrated in small clinical trials
in the United States to have potential in the treatment of ASD.
Under the terms of the agreement, Evgen has agreed to supply
SFX-01 to support a potential future trial to be sponsored by Guy's
and St Thomas' and led by Dr Michael Absoud, Consultant in
paediatric neurodisability at the Evelina London Children's
Hospital ("Evelina"), which is part of Guy's and St Thomas'. The
Trust have agreed to lead the process to secure grant funding and
gain clinical trial approval for a randomised, double blind, Phase
II clinical trial. Evgen will retain the option to acquire, on fair
commercial terms, the clinical data to enable subsequent
development, regulatory approval and commercialisation of SFX-01 in
ASD.
There are currently no approved medicines for treating the three
core symptoms of autism - communication difficulties, social
challenges and repetitive behaviour - which have long represented a
huge area of unmet clinical need for affected families.
Based on its novel mode-of-action, SFX-01 has the potential to
become a first-in-class treatment for the core symptoms of ASD,
disrupting the current GBP3bn ASD market (which includes the use of
anti-depressants and anti-psychotics for the treatment of non-core
symptoms), making a significant impact on the enormous economic
burden to the UK.
Dr Michael Absoud, a consultant in paediatric neurodisability at
Evelina, said: "We are working with patient groups to plan a grant
application for a Phase II clinical trial programme for children
with ASD, hoping to recruit from a consortium of UK hospitals. Our
interest, and that of the parents of some children with ASD, was
first triggered when a small clinical study showed that
sulforaphane helped improve quality of life in autistic young
people. Our end goal is improving the range of treatment options
available for autistic young people, in order to improve quality of
life and independence."
Dr Stephen Franklin, CEO of Evgen Pharma, commented: "As a
result of the successful fundraise in April of this year, we are
now in a position to expand the toxicology package for SFX-01,
which is a prerequisite to being able to support a trial in ASD
patients. SFX-01 works by activating the Nrf2 pathway which in turn
activates the expression of genes that promote the body's innate
capacity to control the oxidative stress and inflammation that
underpin many chronic diseases. Targeting the Nrf2 pathway is now a
recognised therapeutic strategy for treating neurodegenerative
conditions, such as multiple sclerosis, but also neuropsychiatric
disorders, where there is encouraging emergent data in conditions
such as autism and schizophrenia.
"Supporting investigator-led studies such as this enables us to
remain focused on our in-house programmes, whilst recognising that
studies of this nature provide promise to new patient groups and
mitigate risk for our investor base. We look forward to being able
to provide SFX-01 to this trial and to build on the excellent
relationship we have with Dr Absoud and the Trust."
This announcement contains information which, prior to its
disclosure, was considered inside information for the purposes of
Article 7 of Regulation (EU) No 596/2014 (MAR).
Enquiries:
Evgen Pharma plc www.evgen.com
Dr Stephen Franklin, CEO Via Walbrook PR
Richard Moulson, CFO
finnCap
Geoff Nash / Teddy Whiley (Corporate
Finance) +44 (0)20 7220 0500
Alice Lane / Manasa Patil (ECM) researchlibrary.finncap.com
WG Partners LLP +44 (0)20 3705 9330
Nigel Barnes / Claes Spång
Walbrook PR +44 (0)20 7933 8780 or evgen@walbrookpr.com
+44 (0)7980 541 893 / +44 (0)7879
Paul McManus / Anna Dunphy 741 001
Notes for editors:
About Evgen Pharma plc (www.evgen.com)
Evgen Pharma is a clinical stage drug development company whose
lead programmes are in breast cancer and subarachnoid haemorrhage,
a type of stroke. 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.
The Group commenced operations in January 2008 and has its
headquarters at The Colony, Wilmslow, Cheshire, and its registered
office is at the Liverpool Science Park, Liverpool. It joined the
London Stock Exchange Alternative Investment Market in October 2015
and trades under the ticker symbol EVG.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
MSCSSIFLLFUSELU
(END) Dow Jones Newswires
September 05, 2019 02:00 ET (06:00 GMT)
Grafico Azioni Evgen Pharma (LSE:EVG)
Storico
Da Set 2024 a Ott 2024
Grafico Azioni Evgen Pharma (LSE:EVG)
Storico
Da Ott 2023 a Ott 2024