First Patient Dosed in Phase II Trial

RNS Number : 9482W

Evgen Pharma PLC

03 May 2016

 

For immediate release	3 May 2016

 

 

Evgen Pharma plc

 ("Evgen Pharma" or "the Company")

First Patient Dosed in Phase II Clinical Trial in SAH

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 the first patient has been dosed in the Company's Phase II clinical trial of SFX-01 in aneurysmal subarachnoid haemorrhage ("SAH"), a form of stroke.

SFX-01 is a synthetic version of sulforaphane, a known neuroprotective and anti-cancer agent, which is stabilised in a novel patented complex using a proprietary manufacturing process.

The Phase II trial, SAS (SFX-01 after Subarachnoid Haemorrhage), is a randomised, double blind, placebo controlled study comparing oral SFX-01 with placebo. The trial will recruit 90 patients, 45 in each treatment arm with all patients receiving nimodipine, the current standard of care. Patients will be dosed within 48 hours of experiencing SAH and approval has also been obtained in this study to provide for emergency dosing prior to consent. The primary endpoints include safety, pharmacokinetics and efficacy.

Nimodipine has been generic for more than 20 years, during which time there have been no significant clinical advances in the treatment of SAH. Whilst SAH is relatively rare, the market potential for this devastating condition, with its high unmet clinical need, is significant.  In October 2015, Credit Suisse (commissioned by a US peer) estimated potential peak sales of $1.7bn by 2032 for a Phase III development product based on the intraventricular delivery of a nimodipine-based formulation.

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. 

It is expected that the SAS trial will report out Q2 2018. Further details of the study are available at: https://clinicaltrials.gov/ct2/show/study/NCT02614742

The Chief Investigator is Mr Diederik Bulters, Consultant Neurosurgeon and Honorary Senior Clinical Lecturer, at the Wessex Neurological Centre in Southampton.              

Dr Stephen Franklin, Evgen Pharma's CEO, commented: "SAH is a rare and devastating condition, with a high unmet clinical need. Mechanistically, SFX-01 targets the principal drivers of the delayed vasospasm and, unlike nimodipine, is not trying simply to treat the vasospasm per se; as such it may represent the first step-change improvement in therapy in over 20 years. The commencement of the trial is a key milestone for the Company and I would like to thank the Chief Investigator, Mr Diederik Bulters, for his dedication and support."

Enquiries:

Evgen Pharma plc Dr Stephen Franklin, CEO www.evgen.com	c/o [phone]
Buchanan Mark Court, Sophie Cowles, Stephanie Watson		[phone]
Northland Capital Partners Limited Matthew Johnson, Gerry Beaney, Margarita Mitropoulou (Corporate Finance) John Howes (Corporate Broking)		[phone]

Notes for editors:

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 other pharmacokinetic measurements.  

 

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