Following the American Heart Association’s International Stroke Conference (ISC; 5–8 February, Hawaii, USA), Diffusion Pharmaceuticals announce a poster presented at the conference, outlining the on-ambulance phase 2 study with the Company’s lead drug trans sodium crocetinate (TSC) for the treatment of acute stroke.
The poster is titled “Pre-hospital administration of stroke therapy with trans sodium crocetinate (PHAST-TSC) trial,” authored by Andrew M Southerland, University of Virginia Health System, Charlottesville, USA and colleagues.
The poster presents the design of the randomised, double-blind, placebo-controlled PHAST-TSC trial, which will enrol 80 suspected stroke patients in the active arm (0.25mg/kg of TSC) and 80 suspected stroke patients in the control arm (normal saline) at participating stroke centres/emergency medical services in Los Angeles County and central Virginia. The primary trial endpoint is the extent of disability at 90 days using the utility-weighted modified Rankin Scale. Safety endpoints include serious adverse events and all-cause mortality.
TSC holds promise as a neuroprotective agent in acute stroke as it is expected to off-set the decrease that occurs in brain oxygen caused by stroke from either a clot or a bleed. As part of the PHAST-TSC trial protocol, all patients must be treated within two hours of their first stroke symptoms. Administering TSC while the patient is on the ambulance will start this reoxygenation process as soon as possible after the stroke occurs.
An investigational new drug application has been approved by the US FDA and investigational review board approval is pending at participating sites. EMS training and community education for exception from informed consent is about to begin in Los Angeles County and central Virginia. Anticipated enrolment of the first patient is expected this spring, subject to receipt by Diffusion of the necessary funding for the trial.
The poster also includes references to preclinical data suggesting that TSC has benefit for both ischaemic and haemorrhagic stroke, as well as promise in glioblastoma multiforme (GBM) and peripheral artery disease.