Approval of Phase II Clinical Trial in SAH
News Mar 03, 2016
Evgen Pharma plc has announced that it has received the required approvals for the commencement of its Phase II trial of SFX-01 in aneurysmal subarachnoid haemorrhage ("SAH"), a form of stroke. Patient recruitment and first dosing in the 90 patient trial is expected to start in early Q2 calendar year 2016 following the approval of the trial by the Medicines and Healthcare products Regulatory Agency and by a research ethics committee.
Evgen Pharma's SFX-01 is a synthetic and stabilised version of the naturally occurring plant compound sulforaphane, a known neuroprotective and anti-cancer agent. SFX-01 potentially represents a new class of drug in aneurysmal SAH with a mechanism of action that specifically targets the Nrf-2 pathway, which in turn reduces the oxidative stress and the toxicity caused by free haemoglobin from the haemorrhage. Sulforaphane, the active ingredient of SFX-01, has been shown to be neuroprotective in multiple models of cerebral damage, including SAH.
Dr Stephen Franklin, Evgen Pharma's CEO, commented: "We are pleased to have received the required approvals to commence this Phase II trial of our novel compound SFX-01 in aneurysmal subarachnoid haemorrhage. There is a very clear unmet medical need in this condition, for which there has been no significant clinical advances for more than 20 years.
"I am also pleased to report that the Company's other programmes in metastatic breast cancer and multiple sclerosis are proceeding as planned and we will provide updates on these programmes in due course."