Evgen Pharma PLC Progress with UK and US regulators for 2022 trials (9875X)
11 Enero 2022 - 01:00AM
UK Regulatory
TIDMEVG
RNS Number : 9875X
Evgen Pharma PLC
11 January 2022
Evgen Pharma plc
("Evgen" or "the Company" or "the Group")
Progress with UK and US regulators for 2022 clinical trials
Evgen Pharma plc (AIM: EVG), the clinical stage drug development
company developing sulforaphane based medicines for the treatment
of cancers and inflammation, announces that it has progressed
discussions with the UK Medicines and Healthcare products
Regulatory Agency (MHRA) and the US Food and Drug Administration
(FDA) in relation to two clinical trials set to commence in
2022.
The first trial is a Phase I human volunteer study to
investigate the safety, tolerability, pharmacokinetic and
pharmacodynamic properties of Evgen's new SFX-01 tablet
formulation. In addition, the study, which will recruit volunteers
randomised to active and placebo arms, will generate data on dose
escalation and target pathway engagement. Evgen held a scientific
advice meeting with the MHRA in December 2021 at which the draft
trial protocol was discussed and the MHRA's written advice, which
will reflect the discussions on the data to be submitted in support
of approval of the trial, is expected in late January.
Separately, and also in accordance with time lines set out in Q1
2021, Evgen submitted an application for a pre-IND (Investigational
New Drug application) meeting to the FDA in December 2021. This
request has now been granted, to be effected by written responses
to a meeting package that will be submitted to FDA in January. The
IND will relate to a Phase Ib/II trial of SFX-01 in glioblastoma
that is planned to commence in 2022 and Evgen is liaising with
potential trial sites in the UK and Europe. The trial design will
be adaptive to enable extension towards a registration if the data
are supportive of this. In these circumstances trial sites in the
US are likely to be involved.
Part of the proceeds from the 2021 placing and open offer have
been applied to improve the synthesis and formulation of SFX-01 for
commercial scale. This new tablet formulation will be used in all
clinical trials; the production process has started and Evgen
anticipates drug product will be available for commencement of the
Phase I human volunteer study in Q2 this year.
Dr Huw Jones, Chief Executive Officer of Evgen Pharma, said: "I
am delighted with the positive progress that has been made with
MHRA and FDA regarding our two planned clinical trials for SFX-01,
both of which we intend to commence later this year. We look
forward to updating the market in due course regarding further
progress with these key regulatory authorities and with regard to
these two important trials."
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/Harriet Ward (ECM)
Walbrook PR +44 (0)20 7933 87870 or evgen@walbrookpr.com
Paul McManus / Phillip Marriage +44 (0)7980 541 893 / +44 (0)7867 984082
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. SFX-01 has demonstrated efficacy in a Phase
II trial for advanced metastatic breast cancer. It has been used to
treat over 200 patients in clinical trials and is well-tolerated
with predominately mild 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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