Acute Ischaemic Stroke
A clot in the brain vessel of a stroke patient leads to instant death of brain tissue closest to the clot, shown in dark pink. The larger area surrounding the core (shaded) is characterised as the penumbra, tissue which can still be rescued.
MELBOURNE, Australia, Oct. 28, 2020 (GLOBE NEWSWIRE) — The drug afamelanotide will be used for the first time in patients with acute stroke. The study will evaluate the safety and efficacy of afamelanotide, developed by Australian company CLINUVEL, in arterial ischaemic stroke (AIS). The aim is to offer a treatment for patients suffering a stroke who are unable to receive treatment to dissolve or remove the underlying blood clot. AIS accounts for approximately 85% of the 15 million strokes suffered worldwide each year.
“Stroke is most commonly caused by a clot in a patient’s brain which starves surrounding tissue of blood and essential oxygen, causing the destruction of brain cells,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “This brain damage can have an irreversible effect on a patient’s ability to speak, move, and function, and tragically leads to an early death for more than 5.5 million people per annum. It is our aim to show that treatment with afamelanotide can safely reduce and prevent brain damage in the majority of stroke patients who cannot be offered standard therapy.”
Strokes cause death of brain tissue at the site of the clot and lead to a shortage of oxygen in a larger area of the brain, known as the penumbra, which is salvageable brain tissue if treated quickly. The longer the delay in a stroke patient receiving treatment, the greater the potential threat to their life and overall prognosis as tissue within the penumbra becomes irreversibly damaged.
Current stroke therapies rely on early intervention to restore blood flow to the brain by either chemically dissolving or physically removing the clot. In Europe, no treatment can be offered to over 85% AIS patients due to a critical delay between the start of the stroke and presentation of the patient to a hospital. Additionally, the location of the clot within the artery is also an important factor impacting the possibility to offer treatment.
Research has indicated that afamelanotide – which is approved in Europe and the USA for patients with a rare metabolic disorder called EPP1 – may rapidly exert its effects to protect brain tissue, act on blood vessels to optimise blood flow, and reduce the size of swelling in the brain following a stroke. More than 10,000 doses of afamelanotide have been administered to over 1,400 individuals during its development and use across a period of nearly two decades.
The pilot Phase IIa clinical study (CUV801) will be conducted