Navigation Links
CoAxia Announces Results of SENTIS Ischemic Stroke Trial
Date:10/18/2010

MINNEAPOLIS, Oct. 18 /PRNewswire/ -- 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."

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.


'/>"/>
SOURCE CoAxia, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. CoAxia(TM) Announces $11.5M Equity Financing From Existing Investors
2. CoAxia, Inc. Announces $21.5M Series D Financing
3. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
4. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
5. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
6. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
7. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
8. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
9. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
10. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
11. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it ... (procalcitonin) assay as a dedicated testing solution for people ... Roche is the first IVD company in the U.S ... assessment and management. PCT is a sepsis-specific ... blood can aid clinicians in assessing the risk of ...
(Date:6/23/2016)... Bracket , a leading clinical trial technology ... outcomes platform, Bracket eCOA (SM) 6.0, at the 52 ... 30, 2016 in Philadelphia , Pennsylvania.  A ... product of its kind to fully integrate with RTSM, will ... 6.0 is a flexible platform for electronic clinical outcomes assessments ...
(Date:6/23/2016)... LONDON , June 23, 2016 ... environments  Oticon , industry leaders in ... the launch of Oticon Opn ™, the world,s ... world of possibilities for IoT devices.      ... Opn, Oticon introduces a number of ,world firsts,: ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media with ... X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color ... users can now reveal the media of their split screens with growing colorful ...
(Date:6/27/2016)... ... 2016 , ... A revolution is underway. Brooklyn-based company, ... for the millions of people who require these medical transport services annually. ... the use of technology. Now, SmartEMS has put forth an industry-changing app that ...
(Date:6/26/2016)... ... 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic treatment ... Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. This ... of the world’s leading providers of cereal and other breakfast foods. Its residents often ...
(Date:6/26/2016)... ... ... blind and certified personal trainer is helping to develop a weight loss fitness plan that ... the two major problems leading the fitness industry today:, , All ... They don’t eliminate all the reasons people quit their exercise program , ...
(Date:6/25/2016)... ... 25, 2016 , ... Austin residents seeking Mohs surgery services, can now turn ... to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization ... selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction ...
Breaking Medicine News(10 mins):