Evgen Pharma plc, a clinical stage drug development company focused on the treatment of cancer and neurological conditions, is pleased to announce that it has received a positive interim safety review from the independent Data Safety Monitoring Board (“DSMB”) of its Phase II double-blind, placebo-controlled SAS trial of the Company’s lead product, SFX-01, in subarachnoid haemorrhage (“SAH”).
The DSMB review was part of the SAS trial protocol and was triggered by the twentieth patient being dosed (post haemorrhage) for a minimum of seven days whilst in hospital care. The review resulted in a recommendation to proceed as planned, allowing continuation of dosing after discharge from hospital and up to 28 days.
SFX-01 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. The current standard of care is nimodipine, which has a different action and 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 a total of 90 patients will be enrolled; 45 patients will receive SFX-01 and nimodipine and 45 patients will receive placebo and nimodipine. The primary endpoints of the trial, which will report out in the first half of 2018, include safety, pharmacokinetics and efficacy. A total of 26 patients have been enrolled in the study to date.
Evgen Pharma received orphan drug designation from the US Food & Drug Administration in August 2016 for the use of stabilised sulforaphane for the treatment of SAH, a rare form of stroke. Orphan designation gives SFX-01 the potential for US market exclusivity for seven years from the date of marketing approval.
SFX-01 is a synthetic and stabilised version of the naturally occurring plant compound sulforaphane, a known anti-cancer agent and neuro-protective.
Dr Stephen Franklin, CEO of Evgen Pharma, commented: “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.”