Date: 2017-01-11
Type of information: DSMB assessment
phase: 2
Announcement: DSMB assessment
Company: Evgen Pharma (UK)
Product: SFX-01
Action
mechanism: neuroprotective agent. 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. 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 hemoglobin from the haemorrhage.
Disease: aneurysmal subarachnoid haemorrhage
Therapeutic area: Cerebrovascular diseases
Country: UK
Trial
details: This is a safety, tolerability, pharmacokinetic and pharmacodynamic Study of SFX-01 in subarachnoid haemorrhage, with exploratory evaluations of efficacy. 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. (NCT02614742 )
Latest
news: * On January 11, 2017, Evgen Pharma announced that it has received a positive interim safety review from the independent Data Safety Monitoring Board of its Phase II double-blind, placebocontrolled SAS trial of the Company’s lead product, SFX-01, in subarachnoid haemorrhage. 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. The trial 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. * On May 3, 2016, Evgen Pharma announced that the first patient has been dosed in the Phase II clinical trial of SFX-01 in aneurysmal subarachnoid haemorrhage (“SAH”). 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. It is expected that the SAS trial will report out Q2 2018. * On March 2, 2016, Evgen Pharma announced that it has received the required approvals for the commencement of its Phase II trial of SFX-01 in aneurysmal subarachnoid haemorrhage. 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.
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.
