Cancer and neurological condition focused Evgen Pharma said the last study visit had been conducted for the final patient entered into a recent clinical trial of a treatment for subarachnoid haemorrhage, a type of stroke. In the placebo-controlled SAS phase II clinical trial, patients were dosed for a maximum of 28 days following a subarachnoid haemorrhage, covering the period at which they were at risk of a delayed cerebral ischaemia. Patients were 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 and tolerability and blood flow, along with key secondary endpoints measuring cognition, MRI and biomarkers, were expected to be announced in the fourth quarter 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 the treatment -- called SFX-01 -- or the placebo. Nimodipine, first approved in the late eighties, offered a marginal clinical improvement only and there remained a large clinical need to reduce the cognitive deficits that can follow a delayed cerebral ischaemia. The clinical team was now focussed on the cleaning, validation and analysis of the large volume of data collected in this trial. The SAS trial would 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 a STEM trial. That trial involved patients with metastatic breast cancer that had become resistant to hormone therapy and with demonstrable progressive disease. 'We look forward to being able to announce the SAS clinical trial result later this year,' chief executive Steve Franklin said. 'There has been no material innovation, in terms of new drugs for treating subarachnoid haemorrhage, 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.' At 2:59pm: (LON:EVG) Evgen Pharma Plc share price was -1.38p at 16.5p
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