Aurum Biosciences receives UK regulatory approval for a Phase 2 trial of ABL-101 in stroke patients
Aurum Biosciences Ltd (www.aurumbiosciences.com), a Glasgow-based biopharmaceutical company developing a novel, first-in-class stroke therapy and diagnostic, has received approval from the UK regulatory authority (MHRA) for a Phase 2 clinical trial due to start in Q1 2018. Aurum is developing its innovative ABL-101 stroke technology which has the potential to save and improve the lives of thousands of people who have had an acute ischaemic stroke (AIS). This phase 2 trial will investigate both the safety of ABL-101, and novel penumbral imaging that is expected to predict efficacy in stroke patients, utilising Aurum’s proprietary MRI technology. Aurum is collaborating with the NHS Greater Glasgow and Clyde and University of Glasgow, as well as the Wellcome Trust, to develop ABL-101.
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’s 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.”
Stroke is the second biggest killer worldwide with 1 in 6 people having a stroke by the age or 75. Every two seconds someone in the world will have a stroke. Approximately 15 million worldwide suffer an AIS annually, with the global burden continuing to rise (WHO). However, there is only one authorised medicine to treat acute stroke (alteplase, or rtPA), unlike the dozens of products available to treat other major diseases such as cancer or heart disease. To date, spending on stroke research and development has been low in the UK, with only £48 spent on research per stroke patient, compared to £241 spent on cancer. [State of Nation -Stroke Statistics 2017]
The worldwide acute stroke market was valued at $21.5 billion in 2015 and is forecast to reach $31 billion by 2021 [Zion Research].