CoAxia Inc. of Maple Grove, MN, announced today that the results of the SENTIS clinical trial – a worldwide, multi-center, randomized study of its NeuroFlo™ catheter – were presented on Saturday, October 16th, by SENTIS Principal Investigator, Professor Ashfaq Shuaib at the 2010 World Stroke Congress in Seoul, South Korea.
Professor Shuaib noted that SENTIS is the first randomized trial of an acute interventional treatment in ischemic stroke patients to signal safety and long term improvement in clinical outcomes.
CoAxia is developing plans to submit trial results to the US FDA and exploring options to initiate marketing of the NeuroFlo technology in Europe, where it has previously received CE Mark.
Professor Shuaib, Director of Stroke Services, University of Edmonton Medical Center, described the SENTIS trial results as follows: whereas the NeuroFlo treatment did not achieve statistical significance in its primary efficacy measure, it did achieve the trial’s primary safety endpoint and demonstrated numerous positive indications of both safety and benefit.
He presented positive safety results in overall mortality and stroke-related mortality, and improved neurological outcomes, as measured by 90 day modified Rankin 0-2 scores, in early-presenting patients, mid-range stroke patients, and patients over 70 years of age.
The SENTIS trial included patients presenting with strokes up to 14 hours after symptom onset with baseline stroke severity NIHSS scores between 5 and 18. Patients were randomized 1:1 to either NeuroFlo treatment or standard medical care.
Patients eligible for either intra-venous tPA (approximately 2-3% of stoke patients) or intra-arterial clot removal (< 1% of stroke patients) were excluded from the trial. The SENTIS endpoints included a range of neurological efficacy and safety measures assessed 90 days after symptom onset.
These measures included the primary efficacy endpoint of a Return to Normal Neurological Status based on the NINDS Global Score, and secondary efficacy measures of Modified Rankin Scores (mRS 0-2 and Rankin Shift).
Safety outcomes included the primary measure of total Serious Adverse Events and additional measures including Mortality and Symptomatic Intracranial Hemorrhage.
A summary of trial results (based on odds ratio comparisons of treatment and control groups) follows:
•Primary Endpoints:
◦Efficacy: 1.17 odds ratio in the NINDS Global Score; p-value of 0.407
◦Safety: Statistically equivalent rate in Serious Adverse Events
•Secondary/Additional Efficacy Endpoints using the Dichotomized Modified
Rankin 0-2 Score:
◦1.34 odds ratio; p-value of .202 in the entire SENTIS population
◦1.95 odds ratio; p-value of 0.085 in patients who presented within 6 hours of symptom onset
◦2.02 odds ratio; p-value of 0.045 in patients over the age of 70
◦1.80 odds ratio; p-value of 0.055 in patients who present with baseline NIHSS stroke scores of 8 – 14
•Secondary/Additional Safety Endpoints:
◦An all-cause mortality reduction with a 1.56 odds ratio; p-value of 0.133
◦A stroke-related mortality reduction with a 2.31 odds ratio; p-value of 0.016
◦No statistically significant increase in Serious Symptomatic Intracranial Hemorrhage rate in treatment patients vs. controls
Professor Shuaib commented, "SENTIS is the first trial of an interventional device treatment which signals a long term patient benefit and strong safety in such a diverse patient group – one which is representative of the stroke patients we clinicians see every day.
I believe that the NeuroFlo technology represents a significant step forward in stroke treatment – especially for the many stroke patients who have no treatment options today."
Ischemic stroke is one of the largest causes of death and disability in the western world, affecting over 650,000 patients annually and responsible for $70B in annual costs for the long term care of stroke-disabled patients in the United States alone.
Whereas in the US less than 5% of ischemic stroke patients are treated acutely, CoAxia believes that the NeuroFlo technology has the potential to address a much larger portion of the stroke population – a significant potential benefit to stroke patients and the healthcare system.
Andrew M. Weiss, President and CEO commented, "CoAxia is grateful for the participation of stroke teams from the US, Canada, Europe and Israel – for their help in conducting this ground-breaking trial. While SENTIS did not achieve statistical significance in its primary efficacy measure, its signals of safety, mortality reduction and long-term benefit in large, meaningful stroke populations is very encouraging, and we plan to pursue efforts which will allow use of the NeuroFlo catheter in acute stroke."
SOURCE CoAxia, Inc.