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
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 2,400+ scientific posters on ePosters
  • More than 3,700+ 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
Experimental MERS Vaccine Shows Promise in Animal Studies
A two-step regimen of experimental vaccines against Middle East respiratory syndrome (MERS) prompted immune responses in mice and rhesus macaques, report National Institutes of Health scientists who designed the vaccines.
Young South African Women can Adhere to Daily PrEP Regimen as HIV Prevention
NIH-funded study finds men in Bangkok, Harlem also successful in taking daily dose.
Researchers Find Key Player in Diabetic Kidney Disease Through Power of Metabolomics
Discovery could lead to new and better diagnostic marker for chronic kidney disease.
Immunotherapy Shows Promise for Myeloma
A strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
Santhera Announces First Patient Dosing with Omigapil in CMD
Company announces full patient recruitment of CALLISTO study.
Study Shows Promise of Precision Medicine for Most Common Type of Lymphoma
The study appeared online July 20, 2015, in Nature Medicine.
HIV Control Through Treatment Durably Prevents Heterosexual Transmission of Virus
NIH-funded trial proves suppressive antiretroviral therapy for HIV-infected people effective in protecting uninfected partners.
Adaptimmune's Novel Cancer Therapeutics Show Positive Clinical Trial Results
The company has announced that positive data from its Phase I/II study of its affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published.
Early Antiretroviral Therapy Prevents Non-AIDS Outcomes in HIV-infected People
NIH-supported findings illustrate manifold benefit of therapy.
Adaptimmune’s NY-ESO-1 TCR-engineered T-Cells Demonstrate Durable Persistence
Study has been published in Nature Medicine.
Scroll Up
Scroll Down
SELECTBIO

Skyscraper Banner
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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!