NoNO Inc Initiates Phase III Study of NA-1 for Acute Ischemic Stroke

Monday, February 27, 2017 Mental Health News
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A Multicentre, Randomized, Double-blinded, Placebo-controlled, Parallel Group, Single-dose Design to Determine the Efficacy and Safety of Intravenous NA-1 in Subjects with Acute Ischemic Stroke Undergoing Endovascular Thrombectomy (ESCAPE-NA1 trial; NCT02930018)

TORONTO, Feb. 27 2017 /PRNewswire/ - NoNO, Inc., a Canadian biotechnology company and the University of Calgary Stroke Unit announced

today the initiation of its Phase III global clinical trial termed ESCAPE-NA-1 to evaluate the efficacy and safety of the investigational drug NA-1 for reducing functional disability in patients with Acute Ischemic Stroke (AIS) who are candidates for endovascular revascularization.  NoNO Inc. is conducting this trial in collaboration with the University of Calgary Stroke Unit, led by Drs. Michael D. Hill, and Mayank Goyal. The ESCAPE-NA-1 study is based on the successful global clinical trial ESCAPE, conducted by the University of Calgary team (Goyal, M., et al. (2015). "Randomized assessment of rapid endovascular treatment of ischemic stroke." N Engl J Med 372(11): 1019-1030.)

Dr. Michael D. Hill, with the Department of Clinical Neurosciences in the Cumming School of Medicine and member of the Hotchkiss Brain Institute, who is the Coordinating Investigator of ESCAPE-NA-1 and a principal investigator of the ESCAPE trial, stated ""The ESCAPE-NA1 trial is bolstered by our past experience as the global coordinating centre for the successful predecessor study - ESCAPE. We have now set the stage for testing neuroprotection, for the first time, in the human ischemia-reperfusion paradigm. Our experience with ESCAPE will significantly de-risk the operational success of ESCAPE-NA-1."

ESCAPE-NA-1 is a unique clinical trial. Michael Tymianski, M.D., Ph.D., President and CEO of NoNO, Inc., stated "For the first time, neuroprotection will be evaluated in a clinical setting of ischemia-reperfusion in which neuroprotection has the largest treatment effect. ESCAPE-NA-1 addresses the deficiencies of past neuroprotection trials as it is the first study to have a design grounded in- and consistent with- the preclinical science, to minimize subject heterogeneity, to ensure that the treatment effect size is maximized, and to enroll subjects in the correct therapeutic window."

NA-1 belongs to a novel class of drugs termed PSD-95 inhibitors. NA-1 disrupts pro-death signalling pathways that involve postsynaptic density-95 (PSD-95) protein, a major protein found in neuronal synapses.  NA-1 has successfully advanced through Phase 1 and 2 clinical trials in the United States and Canada and currently is recruiting in another Phase 3 trial FRONTIER ( NCT02315443). It has been extensively researched, has a clear mechanism of action, and its efficacy in preclinical studies has been reproduced in multiple indications by several leading laboratories. Preclinical results with NA-1 have been published in leading peer-review journals including Science, Science Translational Medicine and Nature. NoNO Inc. plans to continue developing NA-1, and wishes to thank their collaborators, scientists, investors and the academic stroke community for their continuing support of this important project. 

About NoNO Inc.NoNO Inc. is an Ontario biotechnology company whose focus is on developing therapeutic drugs in areas of unmet medical needs. Its drug pipeline includes therapeutic agents in various stages of development ranging from cellular and molecular discovery to human clinical trials. Its lead projects relate to diseases of the nervous system, including stroke, traumatic brain injury and neuropathic pain. NoNO Inc.'s strategy is to inhibit key protein-protein interactions involved selectively in cellular signals that cause cell damage, but without interfering with normal cell functions.



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