TRI Capital investee Aurum Biosciences has got the official go-ahead for a clinical trial of its innovative stroke technology. The UK’s MHRA regulatory body gave approval for a Phase 2 trial to investigate the ABL-101 technology, which has the potential to save and improve the lives of thousands of people who have had an acute ischaemic stroke (AIS).
The Phase 2 trial will investigate both the safety of ABL-101, and novel penumbral imaging that is expected to predict efficacy in stroke patients, using Aurum’s proprietary MRI technology. The Glasgow company is developing ABL-101 in collaboration with NHS Greater Glasgow and Clyde and the University of Glasgow, as well as the Wellcome Trust.
Aurum’s ABL-101 stroke technology is based on an oxygen carrying perflurocarbon (PFC), which is emulsified for intravenous use. This PFC not only acts as a stroke therapeutic, delivering oxygen beyond the stroke clot, but due to its effect on local oxygenation and in combination with MRI imaging, it is able to detect tissue under metabolic stress.
Thus, ABL-101 has unique dual benefits of reducing brain cell death following acute stroke, while also providing important information guiding the use of further stroke treatments (Aurum preclinical data in press).
Future trials will investigate the effect of ABL-101 on stroke-induced disability both in the overall stroke population, and in thrombectomy patients. The latter is an extremely interesting sub-population of stroke patients in which there have been highly promising recent clinical developments, and which may provide a more rapid route to market for novel stroke therapies.
Aurum Biosciences’ CEO Jim McGuire said: “We are delighted to have received regulatory approval for our ABL-101 stroke trial. Our technology has the potential to significantly improve outcomes for acute stroke patients, not only by delivering oxygen to brain tissue under stress beyond the clot, but by providing acute stroke diagnostics which will direct the use of synergistic acute stroke treatments such as the use of thrombolytics (rtPA) and thrombectomy.”
The Phase 2 trial is expected to start in early 2018.