CoAxia Inc announced the completion of enrolment in its Sentis randomized, controlled, pivotal trial of NeuroFlo Perfusion Augmentation Therapy as an acute interventional treatment for ischemic stroke. The company plans to complete data collection and analysis of results in Q3 of 2010 and, if warranted, submit a PMA to the US FDA.
Ischemic stroke is one of the largest causes of death and disability in the western world, affecting over 650,000 patients annually in the United States alone, and responsible for US$ 70B in annual costs for the long term care of stroke-disabled patients. Whereas in the US approximately 5 per cent of ischemic stroke patients are treated acutely, CoAxia believes that if the NeuroFlo treatment proves safe and effective, as many as 50 per cent of stroke patients may become eligible for treatment - a significant potential benefit to stroke patients and the healthcare system.
The Sentis trial is being performed in the US and Europe under an US FDA IDE, and includes ischemic stroke patients treated within 14 hours of the onset of symptoms. By comparison, the only other approved stroke therapy in the US is the intravenous delivery of the thrombolytic drug tPA, which is approved for a three hour time window. Sentis is a 1:1 randomized, controlled study with a neurological improvement endpoint measured at 90 days after symptom onset. The outcome measure is the Stroke Global Score as defined by the National Institute of Neurological Disease and Stroke (NINDS). With 515 patients enrolled at over 50 stroke centers in 10 countries, CoAxia believes that it will have sufficient patients and site diversity to accurately measure safety and efficacy of the NeuroFlo technology in a broad segment of ischemic stroke patients.
Professor Ashfaq Shuaib, director of Stroke Services at the University of Alberta Medical Center, and Principal Investigator of the Sentis trial commented; "The Sentis trial will provide the safety and efficacy data which stroke neurologists demand for adoption of a new stroke therapy: randomized, controlled data with a 90 day neurological endpoint. CoAxia has conducted this study at the highest level, and I am confident that the quality of the data, if the trial proves positive, will allow clinical adoption of this exciting new technology."
Lorinda Austin, vice president of Clinical Affairs commented, "The Sentis trial is a collaboration between CoAxia and stroke researchers from the US, Canada, Europe and Israel. Completion of enrolment of 515 patients is a key milestone for the trial. It indicates the worldwide clinical interest in the technology, and it signals our new focus: to complete patient data collection and determine our safety and efficacy profile."
Andrew M Weiss, president and CEO commented, "CoAxia has invested more than four years and over US$ 40M in the Sentis trial, and we are excited about the ability to determine the safety and efficacy outcomes of the Sentis trial later this year. If positive, we will have plans in place to submit our PMA to the US FDA as well as initiate commercialization in Europe and around the world."
CoAxia, Inc. is a venture-backed, privately held, clinical-stage company focused on providing perfusion augmentation therapies that improve outcomes for patients with cerebral ischemia resulting from stroke, vasospasm and other conditions.