TORONTO, Jan. 30, 2012/PRNewswire-iReach/ -- NoNO, Inc., a Canadian biotechnology company, announced that the final results of the ENACT Phase 2 clinical trial of their novel stroke drug, NA-1, will be presented by the trial principal investigator, Dr. Michael D. Hill, in Session IX: Late Breaking Science Oral Abstracts, Room R03-05 at the International Stroke Conference in New Orleans on February 2, 2012 at 2:24 pm. This trial executed a novel clinical trial protocol aimed at demonstrating safety and statistically significant reduction of stroke burden in human subjects.
The ENACT trial was a 185-patient, randomized, double-blind placebo-controlled study performed to assess the safety and efficacy of NA-1 in reducing small embolic strokes in patients that underwent an endovascular repair of intracranial aneurysms. Such subjects were demographically similar to patients that suffer from acute ischemic strokes. Patients enrolled in ENACT included individuals who had suffered a brain hemorrhage, in order to evaluate the safety of NA-1 in both ischemic and hemorrhagic strokes. NA-1 belongs to a novel class of drugs termed PSD-95 inhibitors. NA-1 disrupts pro-death signaling pathways that involve postsynaptic density-95 (PSD-95) protein, a major protein found in neuronal synapses. Based upon the results to be presented, NoNO intends to initiate later stage clinical trials in multiple stroke indications including acute ischemic stroke and subarachnoid hemorrhage.
Michael Hill, M.D., the principal investigator for the ENACT trial and Director of the Stroke Unit at Foothills Medical Center, Calgary, stated: “There is a huge unmet need for drugs to treat acute stroke and procedurally-induced strokes, which afflict millions of people worldwide. NA-1 comprises one of the most advanced hopes for success with its novel mechanism and compelling research data.”
Michael Tymianski, M.D., Ph.D., Founder and President of NoNO, Inc., added, “I would like to extend my sincere thanks to the excellent teams of physicians, nurses and staff at the outstanding institutions that participated in the ENACT trial as well as to the patients who agreed to be involved. The results of this trial have encouraged NoNO to proceed with the development of NA-1 and to expand the indications for this drug in further clinical trials.”
NA-1 has been granted Fast-Track Designation by the FDA for the reduction of procedurally induced strokes and cognitive impairment in patients undergoing endovascular repair of brain aneurysms. This designation should facilitate the development of NA-1, as it is directed at the treatment of serious or life-threatening conditions and demonstrates the potential to address multiple unmet medical needs.
NA-1 has successfully advanced through Phase 1 and 2 clinical trials in the United States and Canada. It been extensively researched, has a clear mechanism of action, and its efficacy has been reproduced in multiple indications by several leading laboratories. Preclinical results with NA-1 have been published in leading peer-review journals. NoNO Inc. plans to continue developing NA-1, and thanks their collaborators, scientists, investors and the academic stroke community for their continuing support of this important project.
To obtain more information about this topic, or to schedule an interview, please contact:
Dave Garman, Ph.D.
Telephone: (416) 278-0400
E-mail: dgarman@nonoinc.ca
About NoNO Inc.
NoNO Inc. is an Ontario biotechnology company whose focus is on developing therapeutic drugs in areas of great unmet societal 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.
Media Contact: Dave Garman NoNO Inc., 416-278-0400, dgarman@nonoinc.ca
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SOURCE NoNO Inc.
