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NimoGel™ Shows Promise at Preventing Delayed Complications of Sudden Brain Injury in a Preclinical Study

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Edge Therapeutics has announced that NimoGel™, an investigational sustained-release medicine delivered directly to the brain, prevented delayed complications of sudden brain injury in a preclinical study. In an oral presentation at the American Stroke Association's International Stroke Conference, researchers reported that NimoGel effectively prevented cerebral vasospasm, the constriction of blood vessels in the brain, after subarachnoid hemorrhage (SAH), or sudden bleeding in the space between the middle lining of the brain and the brain itself, in a large-animal model.

This was achieved by obtaining sufficient concentrations of drug at the site of injury and low enough concentrations in the blood to avoid complications. Cerebral vasospasm is a leading cause of permanent brain damage and death after brain injury.

"There is a tremendous unmet medical need in treating brain injuries. Treatments available today are only minimally effective in part because the systemically administered doses that can be tolerated by patients are too low to prevent certain types of delayed complications such as cerebral vasospasm," said R. Loch Macdonald, MD, PhD, Keenan Endowed Chair and Head of the Division of Neurosurgery at St. Michael's Hospital, University of Toronto and Chief Scientific Officer of Edge Therapeutics.

Macdonald continued, "This preclinical study suggests that it is possible to achieve adequate and sustained concentrations of nimodipine locally and prevent cerebral vasospasm and other potentially deadly complications after brain injury. Based on these encouraging results in a large animal model, further evaluation of NimoGel in human clinical trials is warranted."

Dr. Macdonald presented this research in a session titled "Effect of site-specific, sustained-release nimodipine on vasospasm after subarachnoid hemorrhage in dogs." In this study, six dogs were randomized to receive placebo or 10 mg or 30 mg doses of NimoGel administered by intracranial injection.

Thirty mg of NimoGel completely prevented vasospasm for up to 14 days after SAH. Seven days is the time when vasospasm peaks, and vasospasm typically resolves in 14 to 21 days. There were no untoward side effects such as hypotension or abnormal behavior, and no evidence of local brain inflammation on pathologic examination.

"We are very encouraged by these preclinical results and are planning to initiate a Phase 2 clinical trial in patients with ruptured brain aneurysms in 2012," said Brian A. Leuthner, President and Chief Executive Officer of Edge Therapeutics. "This clinical data will help us determine the potential role of NimoGel in improving outcomes for patients with sudden brain injuries."