TIDMEVG
RNS Number : 5489C
Evgen Pharma PLC
12 October 2022
Evgen Pharma plc
("Evgen" or the "Company")
Clinical Trial Update on healthy volunteer study of oral tablet
formulation and glioblastoma programme including scientific
advice
Healthy volunteer study open for recruitment
Alderley Park, UK - 12 October 2022 : Evgen Pharma plc (AIM:
EVG), a clinical stage drug development company developing
sulforaphane-based medicines for the treatment of cancer and other
indications, announces the start of recruitment for the
pharmacokinetic/pharmacodynamic trial in healthy volunteers (HV)
and the decision to commence an Investigator Sponsored clinical
study (ISS) for the glioblastoma programme.
The purpose of the HV study is to examine the performance of
Evgen's new enteric coated tablet formulation of lead asset SFX-01.
Following the regulatory approval announced on 3 October 2022, the
study is now open for recruitment and the first subjects are
expected to enter the trial on schedule this week. The trial is a
placebo-controlled, dose-escalating, randomised trial that will
assess how SFX-01 in its new form and formulation is absorbed and
circulates in the body, and how it engages with target molecules.
Results of the HV study are expected during the first half of
2023.
In glioblastoma (GBM), Evgen has been consulting widely with
world-renowned experts in the treatment of brain cancers with
regards to the planned study. These key opinion leaders have
advised that further pre-clinical work and an early-stage clinical
trial of SFX-01 in patients with GBM should be conducted, to
acquire more clarity on sulforaphane entering the brain tumour and
its interaction with molecular targets in the tumour tissue of GBM
patients. The Company expects that this approach will further
de-risk the Phase 2 clinical trial.
This preliminary clinical work will be conducted as an
Investigator Sponsored Study, led by Dr Marjolein Geurts,
neuro-oncologist at the Erasmus University Medical Centre, the
Netherlands . The Erasmus group has extensive experience in
glioblastoma research, with several studies and numerous
publications in this field. Evgen has already received positive and
supportive regulatory scientific advice from the Dutch Medicines
Evaluation Board (MEB), which also states that there are no
specific concerns related to the clinical safety profile of SFX-01
based on available data. If the pre-clinical and ISS clinical work
is successful, the trial programme is likely to be continued as an
Evgen-sponsored trial. Evgen will update on the timing of this
trial in due course.
Supporting an ISS in GBM for the first clinical phase will
result in the Company having financial resources for a further
year; at least to the end of Q4 2024. This runway will extend well
into 2025 if further milestones relating to the results from the HV
study and FDA IND approval are received following the Stalicla SA
licensing transaction announced this week. Previous guidance issued
was for a much shorter financial runway to Q4 2023.
Glioblastoma and malignant glioma as indications remain areas of
high priority for Evgen, with encouraging pre-clinical data and an
FDA Orphan Drug Designation awarded. Given the status of
glioblastoma as a rare disease with significant unmet clinical
need, the Company will look for partnering opportunities in
parallel to the ISS. Evgen's other programmes, including in breast
cancer, are also continuing as planned.
Dr Huw Jones, Evgen CEO, commented:
"We expect to have a very complete set of data regarding the
performance of the new formulation of SFX-01 by H1 2023, as
planned. This will generate more insight than ever into the way
SFX-01 is handled in the bloodstream and how it interacts with the
key molecular targets of interest in a wide range of diseases.
"We already have promising pre-clinical data in glioblastoma as
well as Orphan Disease status which we announced last year. Given
the complexity of this disease, and the time and cost that goes
into such clinical studies, we want to de-risk the programme as
much as possible. Under advice from experts, we believe a stronger
understanding of the potential direct impacts of SFX-01 in the
brain tumour tissue itself will enable us to improve the trial
design further and enhance the prospects of success.
"In the meantime, we are also focussing on our new and
significant partnership with Stalicla SA and are driving our breast
cancer programme forward in collaboration with the Manchester
Breast Centre. We continue to explore partnering opportunities in
the context of a considerably longer cash runway, with the prospect
of significant further non-dilutive cash inflows from our
partners."
-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 out-licensing 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. Evgen also has a
licensing deal with Stalicla SA in neurodevelopmental disorders and
schizophrenia.
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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