11 Nov 2019 07:00
Evgen Pharma plc
("Evgen Pharma" or the "Company")
SFX-01 results in SAS study
Evgen Pharma (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, announces the results of the "SFX-01 after subarachnoid haemorrhage" (SAS) trial.
The primary endpoint of reducing blood flow velocity in the middle cerebral artery was not achieved, with no significant difference between the SFX-01 and placebo arms.
Furthermore, whilst the secondary endpoints were not statistically powered, there were no differences seen between SFX-01 and placebo in key cognition, quality of life and clinical outcomes at three and six months.
SFX-01 was however shown to be well-tolerated with no safety concerns.
In the multi-centre, randomised, double-blind, placebo-controlled SAS Phase II clinical trial, patients were dosed for a maximum of 28 days following a subarachnoid haemorrhage (SAH), covering the period at which they are at risk of a Delayed Cerebral Ischaemia (DCI). Patients were then monitored for a further five months to assess their recovery by collecting endpoints including cognitive measurements.
In March, the Company reported very positive data from its Phase II STEM trial for the treatment of metastatic breast cancer. Evgen remains well funded and will concentrate its efforts on future partnering whilst developing product formulation for use in STEM II and other investigator-led clinical studies.
Steve Franklin, CEO of Evgen Pharma, said: "We are surprised and disappointed by these findings given the strong preclinical data for sulforaphane in animal models of SAH and other forms of stroke. In March, we reported that SFX-01 had demonstrated positive efficacy and safety data in our STEM trial for metastatic breast cancer, so it is naturally disappointing not to have followed this with another positive result.
"Having achieved our primary endpoints in the metastatic breast cancer Phase II trial, and considering our support for investigator-led clinical studies in alternative disease areas, we will continue to pursue attractive commercial opportunities for SFX-01. However, we will review our Company strategy relating to SFX-01's therapeutic applications, and further announcements will be made in due course."
Enquiries:
Evgen Pharma plc www.evgen.com | via Walbrook | |
Dr Stephen Franklin, CEO | ||
Richard Moulson, CFO | ||
finnCap www.finncap.com | +44 (0) 20 7220 0500 | |
Geoff Nash / Teddy Whiley (Corporate Finance) | ||
Alice Lane, Manasa Patil (ECM) | ||
WG Partners LLP | +44 (0) 20 3705 9330 | |
Nigel Barnes / Claes Spång | ||
Walbrook PR | +44 (0)20 7933 87870 or evgen@walbrookpr.com | |
Paul McManus / Anna Dunphy | +44 (0)7980 541 893 / +44 (0)7876 741 001 | |
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®, 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 Company 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