NEWARK, NJ--(Marketwire - February 11, 2011) - Edge Therapeutics announced today 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 today 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. "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 today 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."
About Cerebral Vasospasm
Cerebral vasospasm is a significant delayed complication and a leading cause of permanent brain damage and death following subarachnoid hemorrhage. Vasospasm occurs three to 14 days after subarachnoid hemorrhage and results in other blood vessels in the brain contracting, thereby limiting blood flow to vital areas of the brain. This reduced blood flow can cause a stroke or additional tissue damage.
NimoGel™, also known as EG-1961, is the lead development candidate in the Company's pipeline of site-specific, sustained-release drug candidates being developed to prevent delayed complications following various types of spontaneous and traumatic brain hemorrhages. A locally delivered, sustained-release formulation of the generic calcium channel blocker nimodipine, NimoGel is designed to provide consistent and sufficiently high nimodipine concentrations in the brain to prevent the catastrophic condition of delayed cerebral ischemia while avoiding previous dose-limiting systemic side effects. Nimodipine microparticles are delivered during the surgery required to secure the bleeding aneurysm -- or are administered minimally invasively when surgery is not required -- so NimoGel use does not necessitate a special surgery or additional procedure.
Edge is developing NimoGel in collaboration with SurModics, a leading provider of drug delivery technologies. Under the terms of a licensing agreement announced by the companies in November 2010, Edge will lead and fund development commercialization of the program, and SurModics will provide Edge access to certain proprietary technologies as well as technical and manufacturing expertise.
About Edge Therapeutics
Edge Therapeutics is a privately held specialty biopharmaceutical company founded in 2009 and funded by private investors, the New Jersey Commission on Science and Technology and the New Jersey Economic Development Authority. Edge believes that local, sustained-release delivery of medicine directly to the injury site in the brain will improve patient outcome and reduce healthcare costs in unmet conditions in the central nervous system. By repurposing and transforming well-established off-patent drugs, Edge streamlines the development path while drastically reducing both risk and cost. Edge's lead product, NimoGel, will soon enter into IND-enabling studies to improve patient outcome after subarachnoid hemorrhage. For more information on Edge Therapeutics, Inc., please visit www.edgetherapeutics.com.