Evgen Pharma plc (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, is pleased to announce 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."
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About Evgen Pharma plc
Evgen Pharma is a clinical stage drug development company whose lead programmes are in breast cancer and subarachnoid haemorrhage, a type of stroke. It is also carrying out preclinical work in multiple sclerosis and has a clinical interest in prostate cancer. The Company's core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. The lead product, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin.
Evgen Pharma commenced operations in January 2008 and is based in Liverpool, UK, at the Liverpool Science Park. It joined the AIM market of the London Stock Exchange in October 2015 and trades under the ticker symbol EVG. For further information please visit www.evgen.com
About SAH and the SAS (SFX-01 after Subarachnoid Haemorrhage) Trial
Aneurysmal SAH is a brain haemorrhage in which blood from a ruptured aneurysm enters the subarachnoid space, a protective barrier surrounding the brain. Aneurysmal SAH accounts for one in every 20 strokes in the UK and approximately 600,000 individuals suffer from it worldwide each year.
The current standard of care for patients with aneurysmal SAH is to repair the aneurysm surgically to prevent re-bleeding. However, a more severe complication of SAH is secondary ischemia caused by vasospasm of blood vessels in the brain. This can lead to further episodes of stroke, resulting in deterioration of the neurological state impairing recovery and is associated with a poor outcome. The current treatment option to prevent this secondary stroke is the calcium channel blocker nimodipine, which has been generic for more than 20 years during which time no significant clinical advances have been made.
Under the design of the Company's Phase II trial, 45 patients will receive SFX-01 and nimodipine and 45 will receive nimodipine with a placebo. The primary endpoints include safety, pharmacokinetic (cerebral spinal fluid)] and efficacy as measured by Middle Cerebral Artery (MCA) peak flow velocity. The secondary endpoints include disability measures using the modified Rankin Scale, the incidence of Delayed Cerebral Ischaemia (DCI) following SAH, long term outcomes and various biomarker and pharmacokinetic measurements.