Evgen Pharma PLC Progress on metastatic breast cancer programme (7159B)
June 14 2021 - 2:00AM
UK Regulatory
TIDMEVG
RNS Number : 7159B
Evgen Pharma PLC
14 June 2021
14 June 2021
Evgen Pharma plc
("Evgen" or the "Company")
Progress on metastatic breast cancer programme
Evgen Pharma plc (AIM: EVG), a clinical stage drug development
company, announces new preclinical data which shows SFX-01 may be
of benefit to metastatic breast cancer ("mBC") patients who have
become resistant to CDK4/6 inhibitors.
Since the STEM open-label Phase II trial of SFX-01 in mBC trial
concluded, CDK4/6 inhibitors have become standard of care as the
first line mBC treatment for the large group of patients who are
estrogen receptor positive (ER+ve). These drugs provide an extended
period of progression-free survival, but invariably patients'
tumours become resistant to them. Options for such patients are
limited, especially since drugs used in this setting are poorly
tolerated. Accordingly, Evgen's collaborators at the Manchester
Breast Centre, the University of Manchester, are conducting further
in vitro preclinical work to assess the impact of SFX-01 in CDK4/6
resistance models. An increasing body of in vitro data from there
shows that in these models SFX-01 may suppress tumour growth and
metastasis in patients who have become resistant to CDK4/6
inhibitors. In particular, SFX-01 reduces the viability and
mammosphere colony formation ability of palbociclib-resistant cells
in vitro.
Palbociclib is the leading CDK4/6 inhibitor. Marketed by Pfizer,
it had sales of circa $5bn in 2019. Mammospheres are colonies of
primary tumour cells which represent a disease-relevant model to
study drug effectiveness.
Should these data be reinforced with in vivo work, the Company
will pursue a Phase II placebo-controlled study a in second line
ER+ve mBC treatment of patients who have failed on CDK4/6
inhibitors. Such a trial could commence in 2022.
The Company's previous open-label STEM trial in patients who had
not received CDK4/6 inhibitors demonstrated:
-- Evidence of anti-cancer activity via objective responses (tumour shrinkage)
-- 24% of patients showed a durable clinical benefit for at
least six months, despite the late stage of disease and patients'
established resistance to hormone therapy. Of these, five patients
were still receiving SFX-01 at 12 months and one patient remained
on SFX-01treatment for 18 months
-- A mild and favourable side effect profile for an anti-cancer drug
Dr Huw Jones, CEO of Evgen, commented: "It is exciting that the
preliminary data set generated by our colleagues at the Manchester
Breast Centre suggests SFX-01 may have a valuable role in the
treatment of patients who have developed CDK4/6 resistance
patients. We will soon be proceeding with the in vivo work and we
are working up the design of the next trial."
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 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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