First Patient Dosed in Phase II Clinical Trial in SAH
News May 07, 2016
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.