25 Jul 2018 07:00
For immediate release | 25 July 2018 |
Evgen Pharma plc
("Evgen" or "the Company")
Final patient recruited in the STEM Phase IIa trial
Evgen Pharma plc (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, announces that it has concluded patient recruitment in its STEM Phase IIa trial of SFX-01 in metastatic breast cancer.
STEM is an open label trial that had regulatory approval to recruit 60 patients. Following the favourable interim read-out, announced on 11 June 2018, the Principal Investigator and the Company's medical adviser believe there is sufficient evidence to conclude that the main aims of the trial, being a favourable safety and tolerability profile and evidence of clinical benefit, have been successfully met. On this basis, the Company has decided that there is no merit in recruiting the full number of patients allowed under the protocol.
As at 24 July 2018, 50 patients had been enrolled in the trial. Any eligible patients currently in screening will also be admitted to the trial.
All eligible patients will continue as per the trial protocol, and will receive SFX-01 until such point as they show clinical progression or reach the end of the trial at 6 months. If they receive clinical benefit for the full duration of the trial, like all other patients in the trial, they will be eligible for entry into the compassionate use programme. On this basis, the final readout will occur around the end of the calendar year; this will include details of the safety, tolerability and the clinical benefit rate observed across all patients.
Dr Sacha Howell, Principal Investigator and Senior Lecturer and Honorary Consultant in Medical Oncology at the Christie NHS Foundation Trust, said:
"The STEM trial is an exploratory trial that was designed to demonstrate safety and tolerability with long-term exposure to SFX-01 and to provide evidence that it has anti-tumour activity after failure of at least one and up to three prior hormone therapies. With these objectives in mind, we have sufficient evidence to believe that SFX-01 warrants further investigation through the conduct of a randomised placebo-controlled trial."
Dr Stephen Franklin, CEO of Evgen, commented:
''We are excited that, so far, the data from our exploratory STEM trial supports further clinical evaluation of SFX-01 and we look forward to the final read-out around the end of the calendar year. The next step is likely to be a placebo-controlled trial, testing SFX-01 in combination with second-line hormone therapy in patients that have failed on CDK4/6 inhibitors. This is the initial setting for which we wish to see SFX-01 approved in metastatic breast cancer."
Enquiries:
Evgen Pharma plc Dr Stephen Franklin, CEO Richard Moulson, CFO www.evgen.com | c/o +44 (0) 20 7466 5000
| |
|
| |
Buchanan Mark Court, Sophie Wills, Tilly Abraham | +44 (0) 20 7466 5000
| |
|
| |
Northland Capital Partners Limited Matthew Johnson, Tom Price, Gerry Beaney (Corporate Finance) Rob Rees (Corporate Broking) | +44 (0) 20 3861 6625 | |
Notes for editors:
About Evgen Pharma plc
Evgen 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.
Evgen 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
For commissioned research on the Company, please visit: http://evgen.com/investors/analyst-coverage/