TIDMEVG
RNS Number : 8076T
Evgen Pharma PLC
25 March 2019
For immediate release 25 March 2019
Evgen Pharma plc
("Evgen" or "the Company")
SFX-01 meets primary endpoints in Phase II STEM trial
for the treatment of metastatic breast cancer
Evgen Pharma (AIM: EVG), a clinical stage drug development
company focused on the treatment of cancer and neurological
conditions, today announces positive headline results from the
open-label Phase II trial of SFX-01 in 46 patients with
estrogen-positive (ER+) metastatic breast cancer.
Highlights
-- Conclusive evidence of anti-cancer activity via objective responses (tumour shrinkage)
-- 24% of patients show a durable clinical benefit for at least
6 months, despite the late stage of disease and patients'
established resistance to hormone therapy
-- Mild and favourable side effect profile for an anti-cancer drug
-- Further development of SFX-01 planned for earlier stage
patients as an adjunct to a second line hormone therapy to delay
onset of resistance
The STEM trial's Chief Investigator, Dr Sacha Howell of the
Christie Hospital, will discuss the headline results today at 9am
GMT via a live webcast and simultaneous conference call. Further
details are set out below.
The STEM trial is the first study of SFX-01 in cancer patients
and had the objectives of evaluating the safety and tolerability of
SFX-01 in combination with an aromatase inhibitor (AI) or tamoxifen
or fulvestrant; and of determining the clinical benefit rate
("CBR") at 24 weeks.
With regards to safety and tolerability, the primary endpoint
was the number and severity of treatment-emergent adverse events
(side effects). As expected, SFX-01 had a favourable side effect
profile, particularly when compared with other drugs used in cancer
therapy. The main side effects were mild (Grade 1) gastrointestinal
symptoms, including nausea and reflux.
With regards to efficacy, the primary endpoint was CBR at 24
weeks - the percentage of patients that had an objective response
(tumour shrinkage by at least 30%) or stable disease for at least
24 weeks. CBR is a standard tool for assessing drug activity in
breast cancer clinical trials. This is a demanding endpoint for
patients that have disease progression (tumour growth) on their
final hormone treatment, and to which SFX-01 was added in the STEM
trial. The CBR was 24%, an improvement on the Interim read-out on
11 June 2018, and included two patients with an objective response,
representing conclusive evidence of anti-cancer activity.
The corporate objective is now to move SFX-01 into a randomised,
double-blind, clinical trial in patients who are earlier in their
treatment pathway and have been treated with only one prior therapy
for metastatic disease. Adding SFX-01 with a newly prescribed
hormone therapy is likely to extend significantly its utility
before resistance is acquired, whilst maintaining a favourable
side-effect profile so that quality of life is not compromised.
Dr Sacha Howell, STEM Chief Investigator, Christie Hospital,
Manchester, UK, said:
"We are very excited by the STEM trial results. This level of
disease stabilisation, coupled with objective evidence of tumour
shrinkage, bodes well for testing SFX-01 earlier in the treatment
path. It would not be unreasonable to expect to see even greater
efficacy when SFX-01 is given alongside a hormone therapy to which
the cancer is naïve, with the intention of delaying the onset of
hormone resistance.
"The clinical need associated with improving the durability of
response to hormone therapies is evidenced by the recent commercial
success of the CDK4/6 inhibitors. However, metastatic breast cancer
remains incurable and despite the initial success with these drugs
all cancers will progress and patients require additional active
therapies. If clinical development continues positively, we can
foresee SFX-01 being used with second line hormone therapy after
CDK4/6 inhibitors' failure. The excellent tolerability of SFX-01
makes this a very attractive proposition."
Dr Stephen Franklin, CEO, Evgen Pharma, said:
"We are absolutely delighted with the trial result and it has
galvanised our enthusiasm and commitment to ensure SFX-01 continues
its development in breast and other cancers. In the context of this
particular patient group, the clinical benefit observed is very
encouraging and we have a high level of confidence that it will
perform even better when used to delay the resistance to a newly
presented second-line hormone therapy.
"Apart from meeting the primary endpoints, we can also report
that of the 46 patients in the trial, 13 registered for the
compassionate use programme enabling access to the drug after
completion of the study and the longest period for which a patient
derived clinical benefit was an outstanding 448 days.
"We now look forward to submitting the data to the 2019 ESMO
Congress in Barcelona, a key event in terms of disseminating the
results to the clinical community and supporting our ongoing
business development activity."
Webcast and conference call
The headline results of the STEM trial will be discussed at 9am
GMT today via a live webcast, accessible at:
http://webcasting.buchanan.uk.com/broadcast/5c6ed00fe6e1d92d38f4f915.
A simultaneous conference call will be provided for analysts and
institutional investors only, including a facility to ask
questions. Dial-in number: + 44 (0) 333 3000 804; PIN
49322076#.
Private shareholders with questions should email them to
evgenpharma@buchanan.uk.com during or after the webcast; the
questions will be collated for inclusion in the webcast.
A recording of the webcast will be available later today in the
Shareholder Information section of the Company's website,
www.evgen.com.
The information contained within this announcement is deemed by
the Company to constitute inside information as stipulated under
the Market Abuse Regulations (EU) No. 596/2014 ("MAR"). Upon
publication of this announcement, this inside information is
considered to be in the public domain.
Enquiries:
Evgen Pharma plc c/o +44 (0) 20 7466 5000
Dr Stephen Franklin, CEO
Richard Moulson, CFO
www.evgen.com
finnCap
Geoff Nash, Teddy Whiley (Corporate
Finance)
Alice Lane, Manasa Patil (ECM)
www.finncap.com +44 (0) 20 7220 0500
WG Partners LLP
Nigel Barnes, Claes Spång +44 (0) 20 3705 9330
Buchanan
Mark Court, Sophie Wills, Tilly
Abraham
evgen@buchanan.uk.com +44 (0) 20 7466 5000
Notes for editors:
About Evgen Pharma plc
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
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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END
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