LONDON (Alliance News) - Evgen Pharma PLC on Wednesday said it has received a favourable review of its Phase II study of its lead product, SFX-01, in subarachnoid haemorrhage.
SFX-01 specifically targets the Nfr-2 pathway and has the effect of reducing the oxidative stress and toxicity caused by free haemoglobin from the haemorrhage.
The clinical stage drug development company said the review was received from the independent Data Safety Monitoring Board and was part of the SAS trial protocol triggered by the twentieth patient being dosed for a minimum of seven days whilst in hospital care.
Evgen said the board recommended the dosing to proceed as planned following the trial, allowing continuation of dosing after discharge from hospital and for up to 28 days.
The trial is a randomised double bind placebo controlled study in which a total of 90 patients will be enrolled, half of which will receive SFX-01. A total of 26 patients have been enrolled in the study to date.
"We are delighted that the Data Safety Monitoring Board has given a favourable review of our Phase II study of SFX-01 in subarachnoid haemorrhage, a rare but devastating condition with high unmet clinical need," said CEO Stephen Franklin.
"This is the first safety review of SFX-01 in a patient cohort and as such represents an important milestone in the clinical development of SFX-01," Franklin added.
Shares in Evgen Pharma were up 9.4% at 26.80 pence on Wednesday morning.
By Hannah Boland; hannahboland@alliancenews.com; @Hannaheboland
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