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

Spectral Diagnostics Provides Clinical Update on the Euphrates Trial

Published: Thursday, March 13, 2014
Last Updated: Wednesday, March 12, 2014
Bookmark and Share
Company has scheduled the next DSMB meeting for early April 2014.

Spectral Diagnostics Inc. has announced an update on its ongoing EUPHRATES trial.

On January 27, 2014, the Data Safety Monitoring Board ("DSMB") met to review the results of the second interim analysis after 184 patients had been randomized and followed for 28 days in accordance with the Statistical Analysis Plan agreed to with the FDA.

On that date, the DSMB reported that stopping rules for safety, efficacy and futility were not met and that the trial should continue. The DSMB did not, however, provide the planned sample size recalculation at that time.

The DSMB requested that additional analysis be performed by the Contract Research Organization on the original 184 patients prior to the recalculation. This analysis is ongoing and is expected to take several more weeks to complete. In the meantime, the enrollment in EUPHRATES continues with currently 256 patients randomized.

Spectral has scheduled the next quarterly DSMB meeting for early April 2014, at which time it expects to receive the recommendations of the DSMB based on its review of the requested detailed analysis, as well as data from additional patients enrolled since the 184 patient cut off for the second interim analysis.

A sample size recalculation is expected to be performed and reported to the Sponsor, as well as any other recommendations.

The EUPHRATES trial was designed to show a benefit in mortality between the treated group and the control group of between 10% to 15% at a power of eighty percent.

The original sample size of 360 enrolled patients would be required to show a 15% benefit in mortality, while demonstrating a 10% difference could require up to approximately 700 patients.

The Company expects to announce its clinical pathway forward after receiving and evaluating the DSMB recommendations.


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 3,500+ scientific posters on ePosters
  • More than 5,000+ 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 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 Results of First Interim Analysis by Data Safety and Monitoring Board
Enrolment in the EUPHRATES trial is continuing with no safety issues.
Wednesday, February 06, 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
Advanced Lymphoma in Remission After T-Cell Therapy
63% of trial participants who recieved two-drug combination chemo plus intermediate dose of engineered T cells went into complete remission.
New Treatment for Immune Cancers
Clinical trial shows new drug holds promise for treating advanced mastocytosis.
Sickle Cell Gene Therapy Passes Test
Researchers found a precision-engineered gene therapy virus reduced sickle-induced red-cell damage in mice with sickle cell disease.
Opening Door to Oesophageal Cancer Targeted Treatments
Scientists have discovered that oesophageal cancer can be classified into three different subtypes.
Inovio Launches Zika Vaccine Trial
Inovio launches Zika vaccine trial in midst of Puerto Rico epidemic to explore early signals of vaccine efficacy.
Vitamin C May Boost Leukemia Treatment
Studies show that supplementing an epigenetic cancer drug with vitamin C enhanced the drug's effectiveness.
New Hope for Zika Treatment Found in Large-Scale Screen of Existing Drugs
Johns Hopkins researchers join collaborative group to screen 6,000 existing drugs in hopes of finding treatments for Zika Virus infection
FINCH Filgotinib Phase 3 Program Initiated
Galapagos NV reports the initiation of the FINCH global Phase 3 program in rheumatoid arthritis patient populations.
Stem Cell Therapy Heals Injured Mouse Brain
A team of researchers has developed a therapeutic technique that dramatically increases the production of nerve cells in mice with stroke-induced brain damage.
Zika Vaccine Testing in Humans
The NAAID has initiated a clinical trail of a vaccine candidate for the prevention of the Zika virus infection.
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
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!