RNS EVG18 Mar 2019 07:52
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."
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