Positive DSMB Review of SAS Trial
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For immediate release |
11 January 2017 |
Evgen Pharma plc
("Evgen Pharma" or "the Company")
Positive DSMB Review of SAS Trial
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 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."
Enquiries:
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Evgen Pharma plc Dr Stephen Franklin, CEO |
c/o +44 (0) 20 7466 5000
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Buchanan Mark Court, Sophie Cowles, Stephanie Watson |
+44 (0) 20 7466 5000
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Northland Capital Partners Limited Matthew Johnson, Gerry Beaney, Margarita Mitropoulou (Corporate Finance) John Howes and Rob Rees (Corporate Broking) |
+44 (0) 20 3861 6625 |
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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.
This information is provided by RNS
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