Development and Testing of a Neuroprotective Solution

DESCRIPTION (provided by applicant): Central nervous system (CNS) tissue is extremely sensitive to injuries and ischemic insult. Protecting brain and spinal cord has been a pressing goal of neuroscientists for years. To date, a broad spectrum of compounds with disparate mechanisms of action have been considered, from oxygen free radical scavengers, calcium channel blockers, glutamate receptor antagonists to monoclonal antibodies that attempt to curtail inflammatory cascades during brain and spinal cord injuries, yet no real breakthrough has been achieved. What has been overlooked, however, is a "no-reflow" or "low reflow" phenomenon. Targeting this, we have designed a neuroprotective solution. The goal of this project is to further develop this neuroprotective solution and perform animal testing. In the final goal, we anticipate that this neuroprotective solution can be placed on clinical trial and eventually revolutionize the treatment for all acute neurological injuries. In phase 1 of this project, we will optimize this solution and test its neuroprotective efficacy on animals. In phase 2 of this project, we will set the criteria according to FDA's new drug regulation; manufacture samples by GMP standard; perform pre-clinical studies on animals regarding this neuroprotective solution's safety, efficacy, and toxicity. At completion of Phase 1 and Phase 2 work, we will apply for an Investigative New Drug (IND).