Evgen Pharma plc - Last patient visit reached in the SAS study, a phase II trial of SFX-01 after subarachnoid haemorrhage.
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Release date- 28082019 - Evgen Pharma (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, announces that the last study visit for the last patient entered in the double-blind, placebo-controlled SAS Phase II clinical trial has taken place.
In the SAS trial, patients are dosed for a maximum of 28 days following a subarachnoid haemorrhage, covering the period at which they are at risk of a Delayed Cerebral Ischaemia (DCI). Patients are then monitored for a further five months to assess their recovery by collecting endpoints including cognitive measurements and MRI scans.
The top line results for the primary endpoints of safety/tolerability and blood flow, along with key secondary endpoints measuring cognition, MRI and biomarkers, are expected to be announced in Q4 2019, as previously communicated.
The trial recruited a total of 104 patients, split into two arms in a randomised, double-blind, placebo-controlled trial. All patients received the current standard of care, a calcium channel blocker called Nimodipine in addition to SFX-01 or the placebo. Nimodipine, first approved in the late eighties, offers a marginal clinical improvement only and there remains a large clinical need to reduce the cognitive deficits that can follow a DCI. The clinical team is now focussed on the cleaning, validation and analysis of the large volume of data collected in this trial.
The SAS trial will be the second Phase II clinical trial readout from Evgen this year after it was announced in March that SFX-01 had successfully met the primary endpoints in the STEM trial - an open label Phase II trial in patients with metastatic breast cancer that had become resistant to hormone therapy and with demonstrable progressive disease.
Steve Franklin, CEO of Evgen Pharma, said: 'We look forward to being able to announce the SAS clinical trial result later this year. There has been no material innovation, in terms of new drugs for treating subarachnoid haemorrhage (SAH), for approximately thirty years and so a positive readout would represent significant news for the pharmaceutical industry. On an annual basis, around 75,000 people have an SAH in the US and EU and, based on the most recent analyst forecast, this could translate into peak sales of approximately $500m. We have already secured orphan drug designation in the US and the SAS trial will enable an application for similar status in Europe.'
Dr Stephen Franklin
Tel: +44 (0) 20 7220 0500
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. 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.
The Company commenced operations in January 2008 and has its headquarters at The Colony, Wilmslow, Cheshire, and its registered office is at the Liverpool Science Park, Liverpool. It joined the AIM market of the London Stock Exchange in October 2015 and trades under the ticker symbol EVG.
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((Distributed via M2 Communications - http://www.m2.com))
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|Date:||Aug 29, 2019|
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