Evgen Pharma PLC Regulatory approval for healthy volunteer study (0697B)
29 Settembre 2022 - 8:00AM
UK Regulatory
TIDMEVG
RNS Number : 0697B
Evgen Pharma PLC
29 September 2022
Evgen Pharma plc
("Evgen" or the "Company")
Regulatory approval received for healthy volunteer study to
investigate performance
of new SFX-01 formulation
Alderley Park, UK - 29 September 2022 : Evgen Pharma plc (AIM:
EVG), a clinical stage drug development company developing
sulforaphane-based medicines for the treatment of cancer and other
indications , has received regulatory and ethical approvals for a
healthy volunteer, pharmacokinetic and pharmacodynamic, study to
examine the performance of the Company's new enteric coated tablet
formulation of lead asset SFX-01.
As well as safety, the study will investigate how sulforaphane
released from SFX-01 engages with key molecular targets that are of
interest to Evgen's plans for clinical trials in cancer and other
indications.
Evgen developed the enteric-coated tablet formulation to replace
previously used hand-filled capsules. The new coating is expected
to release sulforaphane to a targeted part of the intestine,
improving pharmacokinetic properties and minimising
gastro-intestinal side effects. The new formulation, if it performs
as expected, will be suitable for large scale trials and commercial
supply. SFX-01 is the only stabilised sulforaphane suitable for
clinical research and eventual approval as a medicine.
Dr Huw Jones, Evgen CEO, commented:
"These approvals will enable us to launch our healthy volunteer
study on schedule in the fourth quarter. This important study will
provide deeper insights into our new formulation of SFX-01, its
metabolism and the way it interacts with selected molecular
targets, which will be key to informing future development work and
trials."
The Phase I/Ib study will be a placebo-controlled,
dose-escalating, randomised trial conducted in the UK. It is
planned to start in Q4 2022, with results expected in the first
half of 2023.
SFX-01 is a patented composition of synthetic sulforaphane and
alpha-cyclodextrin. The Company has already completed three trials
in patients, including a positive open label trial in metastatic
breast cancer using a prototype capsule formulation.
Evgen's core technology is Sulforadex(R), a method for
synthesising and stabilising the naturally occurring compound
sulforaphane and novel proprietary analogues based on sulforaphane.
Sulforaphanes have shown potential benefits in neurodevelopmental
disorders, oncology and inflammatory conditions.
A pharmacokinetic study looks at how the drug is absorbed and
circulates in the body, while a pharmacodynamic study investigates
how the drug engages with molecular targets relevant to
disease.
-Ends-
Enquiries:
Evgen Pharma plc Tel: +44 1625 466591
Dr Huw Jones, CEO
Richard Moulson, CFO
FinnCap (Nominated Advisor and Tel: +44 20 7220 0500
Broker)
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane/Nigel Birks (ECM)
Instinctif Partners Tel: +44 207 457 2020
Melanie Toyne-Sewell / Rozi Morris Evgen@Instinctif.com
/ Agnes Stephens / Adam Loudon
Notes to Editors
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 Company's lead asset, SFX-01, is a patented composition of
synthetic sulforaphane and alpha-cyclodextrin and has undergone
clinical trials for oestrogen-positive (ER+) metastatic breast
cancer In September 2021 the FDA granted Orphan Drug status to
SFX-01 in malignant glioma.
The Company also has a wide number of collaborations with
leading academic centres in the UK, Europe and AsiaPac as part of
the continuing strategy to build the data set of safety and
efficacy around the compound. With respect to non-core area, Evgen
signed an outlicensing deal with JuvLife, the dietary products and
functional foods division of Juvenescence Ltd, for the development
of a naturally-sourced sulforaphane nutritional health supplement,
stabilised using Evgen's Sulforadex(R) technology.
The Company has its headquarters and registered office at
Alderley Park, Cheshire. 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 .
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