CoAxia has completed enrollment in its Sentis randomised, 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 FDA.
The Sentis trial is being performed in the US and Europe under an 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 randomised, controlled study with a neurological improvement endpoint measured at 90 days after symptom onset. With 515 patients enrolled at over 50 stroke centers in ten 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.
Ashfaq Shuaib, principal investigator of Sentis trial, said: “The Sentis trial will provide the safety and efficacy data which stroke neurologists demand for adoption of a new stroke therapy: randomised, 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 at CoAxia, said: “The Sentis trial is a collaboration between CoAxia and stroke researchers from the US, Canada, Europe and Israel. Â Completion of enrollment 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 Weiss, president and CEO of CoAxia, said: “CoAxia has invested more than 4 years and over $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 FDA as well as initiate commercialization in Europe and around the world.”