18 Mar 2019 07:00
For immediate release | 18 March 2019 |
Evgen Pharma plc
("Evgen Pharma" or "the Company")
Update on SFX-01 trial read-out dates
Final read-out data from Phase II STEM trial expected next week
Evgen Pharma (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, announces the following update on the read-out of its two Phase II trials of SFX-01, the Company's lead development product.
The final read-out of the STEM trial in metastatic breast cancer is expected to be announced early next week, in line with the Company's earlier guidance of Q1 2019.
In the SAS trial of SFX-01 in subarachnoid haemorrhage, the Company is pleased to confirm that the treatment phase of the trial has now concluded with the last patient on the trial having received the final patient dose.
Following advice from clinicians and statisticians, and in the light of commercial considerations, the Company has decided to announce the primary endpoints (safety, tolerability and measures of blood flow in the brain) and secondary endpoints (relating to cognitive function) at the same time, rather than announcing them separately as previously indicated. This approach fully protects the blinded integrity of the secondary endpoint data which continues to be collected post-dosing for six months from the initial haemorrhage.
The SAS trial will therefore remain fully blinded until all of the secondary endpoint data has been collected. The final read-out continues to be expected in late summer 2019.
Steve Franklin, CEO of Evgen Pharma, commented:
"This is a hugely exciting time for Evgen as we build up to the read-out early next week of our Phase II clinical trial of SFX-01 in metastatic breast cancer. These results are expected to be followed in the late summer this year by the final read-out of our SAS Phase II trial of SFX-01 in subarachnoid haemorrhage.
"Following discussions with our clinicians and statistical advisers, we have decided to unblind the SAS trial's primary and secondary endpoint data at the same time. By doing this, we will fully maintain the blinded integrity of the secondary endpoint data, which in this trial are particularly important as they will form the basis of the primary endpoints in subsequent studies. This approach will maximise the commercial value of the dataset from the SAS trial."
Enquiries:
Evgen Pharma plc Dr Stephen Franklin, CEO Richard Moulson, CFO www.evgen.com
| c/o +44 (0) 20 7466 5000 |
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®, 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