Clinuvel has announced that its drug afamelanotide has been administered to a first patient diagnosed with an acute arterial ischaemic stroke (AIS) enrolled in a clinical trial (CUV801).
The company said that due to a clot formed in the higher region of the left middle cerebral artery (M2 or above), the patient suffered an acute stroke and was admitted to a specialist neurological hospital in Australia to receive treatment.
In total, six adult AIS patients will be evaluated in the Phase II CUV801 study said the company. The study focuses on the safety and therapeutic potential of afamelanotide in patients who are ineligible for standard stroke therapy.
Stroke is the second most common cause of death and a leading cause of disability worldwide. Yet many stroke patients are unsuitable to receive the current standard of care - clot removal and clot dissolution.
Acute stroke most frequently occurs unexpectedly and without warning. The main reason for AIS is a severe constriction of, and a clot lodged within the brain vessel. AIS leads to an immediate lack of oxygen and glucose supply, resulting in partial death of brain tissue. A stroke patient may suddenly lose consciousness, and typically will experience loss of movement of one side of the body.
Unfortunately, the majority of stroke patients do not receive standard therapy because it cannot be offered within the internationally accepted critical treatment window of four and a half hours, or because the clot is lodged in inaccessible parts of the brain (M2 branch and higher).
“The immediate aim in acute AIS treatment is to bring back the patient’s neurological and muscular functions by improving the blood flow to the affected site of the brain,” said Clinuvel's clinical operations manager, Dr Pilar Bilbao.
“Our unambiguous aim is to develop a treatment for 70% to 80% of the stroke patients who currently have no alternative treatment”.
The company said afamelanotide is known to offer neuroprotection and act as a potent anti-oxidative hormone. The drug possesses further therapeutic benefits, activating vessels, reducing fluid formation, protecting critical nerve and brain tissue, and restoring the blood-brain barrier.