LONDON (ShareCast) - (ShareCast News) - Evgen Pharma, a clinical stage drug development company focused on the treatment of cancer and neurological conditions, has received a positive interim safety review from the independent Data Safety Monitoring Board (DSMB) for its Phase II double-blind placebo-controlled SAS trial of SFX-01 in subarachnoid haemorrhage (SAH).
The DSMB review was part of the SAS trial protocol and was triggered by the 20th patient being does for a minimum of seven days whilst in hospital care. The review resulted in a recommendation to proceed as planned, continuing the dosages after being discharged for up to 28 days.

SFX-01, a synthetic and stabilised version of the naturally occurring plant compound sulforaphane, potentially represents a new class of drug in SAH, with a mechanism of action that specifically targets the Nrf-2 pathway and has the effect of reducing the oxidative stress and toxicity caused by free haemoglobin from the haemorrhage.

Nimodipine is the current standard of care and has a different action. It has been generic for more than 20 years during which time there have been no significant clinical advances in the treatment of SAH.

The SAS trial is a randomised, double blind, placebo controlled study in which half of the patients will receive SFX-01 and nimodipine and the other half will receive placebo ad nimodipine. A total of 90 patients will be enrolled. A total of 26 patients have been enrolled in the study to date.

Chief executive of Pharma Dr Stephen Franklin said: "We are delighted that the DSMB 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. 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."

The share price fell 1.63% to 24.10p at 1027 GMT on Wednesday.

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