First patients enrolled on study aimed to improve outcome following brain injury.

Formed from around 80-90 billion neurons and with a consistency so soft you could cut

A CT of the head years after a traumatic brain injury showing an empty space marked by the arrow were the damage occurred.
A head CT image taken years after a traumatic brain injury, showing an empty space marked by the arrow were the damage occurred.

it with a table knife, the brain is a delicate vulnerable organ. Unfortunately, despite its hard outer shell (the skull), the brain is still susceptible to many forms of damage, both external and internal. Two common forms of brain damage are subarachnoid haemorrhage (SAH – a type of stroke caused by bleeding in and around the brain) and traumatic brain injury (TBI – occurring when an external force causes injury to the brain, i.e. hitting your head). It is not always possible to prevent this type of injury, however, scientists from Edge Therapeutics, Inc are currently working hard to develop life-saving hospital products capable of improving the outcome of patients following SAH and TBI.

Edge Therapeutics are currently enrolling patients on Phase I/II clinical trials for their pipeline drug EG-1962. Despite its inaccessible name, EG-1962 is designed to perform a unique and possibly life-saving function. The drug is designed to treat a state known as delayed cerebral ischemia (DCI). DCI is a complication and major cause of death and disability which occurs in patients within the first two weeks following brain injury. As the name suggests, DCI causes cellular damage through ischaemia (restriction of blood flow to the tissue). This ischaemia can result from a number of mechanisms stemming from the site of brain injury, including cerebral vasospasm (a narrowing of vessels carrying blood), cortical spreading ischaemia (decreased blood flow caused by mass activation of large populations of brain cells) and microthrombembolism (a blockage of blood flow around small, trauma-induced blood clots).

Cerebral angiogram showing the blood vessels in a brain.

EG-1962, also referred to as nimodipine microparticles, is a novel preparation of the FDA-approved drug nimodipine. This preparation encapsulates nimodipine in a biodegradable coating which can be injected directly at the site of injury, releasing nimodipine steadily over a period of 21 days. This new system is thought to be an improvement on the current method of oral delivery, which is more likely to cause nasty side effects (such as low blood pressure and lung complications) and less likely to supply sufficient drug to areas where it is needed.

E. Francois Aldrich, M.D. (an Associate Professor of Neurosurgery at the University of Maryland and the Chief of Cerebrovascular Surgery) stated that he hopes the study will help select on optimal dose of EG-1962, which could potentially prevent DCI, therefore improving the lives of a number of patients suffering from various forms of brain injury.

The current study, dubbed NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage), will enrol up to 96 patients in approximately 20 centres internationally. This study aims to ensure EG-1962 is safe; to discover the most safely effective dose; and to assess whether EG-1962 offers a significant improvement over oral nimodipine. Results are expected in the first half of this year and Dr. R. Loch Macdonald, Chief Scientific Officer at Edge Therapeutics, hopes that these findings will lead to further advances in the clinical development of the drug.

Although a significant number of drugs undergoing Phase I/II trials will fail to progress any further, it is hoped that this treatment or similar preparations may soon be available to reduce the damage caused by DCI.

Post by: Sarah Fox

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