The Clinuvel Pharmaceuticals Limited (ASX: CUV) share price is on the move again following the release of its third announcement in as many days.
In morning trade the biopharmaceutical company's shares are up 2% to $22.07.
What did Clinuvel announce?
This morning Clinuvel announced that it will trial the drug afamelanotide for the first time in patients with acute stroke.
According to the release, the study will evaluate the safety and efficacy of afamelanotide, which was developed by Clinuvel, in arterial ischaemic stroke (AIS).
The study's 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.
Management notes that AIS accounts for approximately 85% of the 15 million strokes suffered worldwide each year. Furthermore, in the United States alone, recent estimates place the cost of stroke in excess of $34 billion per year.
Clinuvel's Chief Scientific Officer, Dr Dennis Wright, commented: "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. 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," he added.
Why might afamelanotide be a treatment option?
The company notes that research indicates that afamelanotide, which is approved in Europe and the USA for patients with a rare metabolic disorder called EPP, 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.
The pilot Phase IIa clinical study will be conducted at a single expert neurological emergency centre, assessing the safety and effectiveness of an injectable controlled-release implant formulation of afamelanotide in AIS patients. Six adult patients with clots located in the higher segments of the brain and who are ineligible for alternative treatments will be enrolled in the study and evaluated for six weeks.
Dr Wright explained: "The objective of intervention with afamelanotide is to safely assist the restoration of blood flow and oxygen supply to the brain while minimising the traumatic damage and fluid accumulation. For our team, the ultimate aim is to reduce the overall damage stroke does to those patients."
"Having monitored the real world use of SCENESSE in patients in Europe and the USA, we have now collected sufficient safety data to further our clinical programs in life threatening disorders. We look forward to the first study results in the first half of 2021, but also depending on the capacity of hospitals due to the COVID pandemic," the chief scientific officer concluded.
