Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Spectral Announces Results of First Interim Analysis by Data Safety and Monitoring Board

Published: Wednesday, February 06, 2013
Last Updated: Tuesday, February 05, 2013
Bookmark and Share
Enrolment in the EUPHRATES trial is continuing with no safety issues.

Spectral Diagnostics Inc. has announced that the first interim analysis has been conducted on the initial 76 randomized patients in its EUPHRATES trial.

The Data Safety and Monitoring Board (DSMB), consisting of experts in the fields of critical care medicine, infectious disease, nephrology, biostatistics and regulatory affairs, reviewed the totality of the data set for evidence of safety concerns, such as adverse events and/or adverse device effects, related to the use of the Toraymyxin cartridge.

The results from the first interim safety analysis by the DSMB state that there are no safety issues to date concerning the application of the Toraymyxin cartridge to patients in the EUPHRATES trial.

In addition, the results state that the EUPHRATES clinical protocol appears to be defining the correct target patient population for this study.

"We are making consistent progress with our pivotal Phase III trial," said Dr. Paul Walker, Chief Executive Officer of Spectral Diagnostics.

Dr. Walker continued, "We remain committed to our protocol which randomizes only patients in septic shock who are endotoxemic, as they are at greatest risk for a poor outcome and therefore most likely to benefit from our theranostic approach."

There have been 191 patients who have met clinical entry criteria so far. As predicted, approximately 50% of these patients have an elevated level of endotoxin, which is associated with a high rate of mortality in septic shock patients.

The combined 28-day mortality rate remains stable at 35% for patients randomized either to the standard of care with SHAM hemoperfusion event, or to the Toraymyxin cartridge plus standard of care.

This was also commented on by the DSMB as a positive sign and provides further evidence that the correct patient population is being studied.

For those patients with low levels of endotoxin who were not randomized to the trial, the 28-day mortality rate is approximately 25% to date.

The DSMB encourages the continued enrolment of patients into the EUPHRATES trial.

Spectral continues to initiate new sites to the EUPHRATES trial in Canada and the United States. The Company anticipates that it will have 45-50 sites enrolling patients by the end of June, 2013.

Spectral remains on track to achieve the trial's next milestone, which will be a second planned interim analysis after 184 randomized patients have been followed for 28 days.

At the second analysis, the DSMB will advise Spectral on the trial's safety, efficacy or futility, with stopping rules in place for efficacy and futility.

A sample size recalculation will be done if necessary. Management expects to disclose information from the second interim analysis in the first half of 2014.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 4,000+ scientific posters on ePosters
  • More than 5,300+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

U.S. FDA Approves Spectral's Amended Protocol for its EUPHRATES Trial
Additional exclusion criterion added to the clinical protocol.
Thursday, June 05, 2014
Spectral Updates Status of EUPHRATES Trial
Trial to continue with a total of 650 patients.
Tuesday, April 15, 2014
Spectral Announces Fourth Quarter and Fiscal 2013 Results
Company announces fourth quarter highlights and financial review.
Tuesday, April 01, 2014
Spectral Diagnostics Provides Clinical Update on the Euphrates Trial
Company has scheduled the next DSMB meeting for early April 2014.
Thursday, March 13, 2014
Spectral Announces Status of Second Interim Analysis
DSMB evaluates the safety, efficacy and futility of Company’s EUPHRATES trial.
Friday, January 31, 2014
Spectral Announces Third Quarter 2013 Results
Company to disclose information from the second interim analysis in early 2014.
Monday, November 18, 2013
Spectral Announces Second Quarter 2013 Results
Appointment of Dr. Gualtiero Guadagni as the Company's Vice President.
Wednesday, August 14, 2013
Spectral Provides Update on its EUPHRATES Trial
Trial is on track and continues to enroll patients at an accelerated rate.
Monday, August 05, 2013
Spectral Appoints Vice President of Sales and Marketing
Appointment of Dr. Gualtiero Guadagni as the Company's Vice President.
Tuesday, July 09, 2013
Spectral Announces First Quarter 2013 Results
Company's Phase III EUPHRATES trial enrolled by the end of 2014.
Thursday, May 16, 2013
Toray Makes $5 Million Strategic Investment in Spectral Diagnostics
Private placement expected to close at the beginning of April, 2013.
Monday, March 11, 2013
Spectral Announces Third Quarter 2012 Results
U.S. FDA approved an amended protocol for Spectral's Phase III EUPHRATES trial.
Friday, November 16, 2012
Spectral Announces Second Quarter 2012 Results
Spectral to double the number of trial sites for the Company's personalized medicine approach to treating septic shock.
Friday, August 17, 2012
Spectral Diagnostics Provides Update on Euphrates Trial
FDA allows Spectral to double the number of trial sites for the Company's personalized medicine approach to treating septic shock.
Monday, June 25, 2012
Spectral Announces First Quarter 2012 Results
Enrollment of patients into the Company's Phase III EUPHRATES trial.
Thursday, May 17, 2012
Scientific News
Gene Therapy Maintains Clotting Factor for Hemophilia Patients
Following a single gene therapy dose, the highest levels of an essential blood clotting factor IX were observed in hemophilia B patients.
BioCision Forms MedCision
The new company will focus on technologies for the management and automation of vital clinical processes.
First New HIV Vaccine Study for Seven Years Begins
South Africa hosts historic clinical trial of experimental HIV vaccine aiming to safely prevent HIV infection.
Study to Assess Shorter-Duration Antibiotics in Children
Physicians plan a clinical trial to evaluate whether short course anti-biotics are effective at treating CAP in children.
Cancer Gene Predicts Treatment Response in Leukaemia
Study indicates the patients suffering from a lethal for of acute myeloid leukemia may live longer when receiving milder chemotherapy drugs.
Injectable Biologic Therapy Reduces Triglycerides
Study finds first-of-its-kind therapy promising for patients with high triglycerides, cholesterol.
Testing Zika Vaccine in Humans Begins
The first of five planned clinical trials to test ZPIV vaccine in humans has begun.
Combination Therapy Improved Chemoresistance in Ovarian Cancer
The study demonstrates how an existing class of targeted therapies could be used to potentiate the tumor suppression induced by cisplatin.
Gene Therapy for Blistering Skin Disease Shows Promise
Grafting genetically altered skin onto patients’ chronic wounds marks the first time skin-based gene therapy has been demonstrated to be safe and effective in humans.
Alzheimer’s Treatment Moves a Step Closer
Merck scientists have reported the discovery of verubecestat, a structurally unique, orally bioavailable small molecule that has been shown to target the most visible sign of the disease in the brain.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!