Spectral Updates Status of EUPHRATES Trial
News Apr 15, 2014
Spectral Diagnostics Inc. has announced that the Data Safety Monitoring Board (DSMB) for the EUPHRATES trial has completed its review of the detailed analysis it had previously requested.
Based on the current recommendations of the DSMB, the sample size has been recalculated and increased from 360 to 650 patients.
This increase in the number of enrolled patients enhances the likelihood of demonstrating, with sufficient power, a statistically and clinically significant effect. The revised sample size falls within the statistical plan already agreed to by the United States Food and Drug Administration (FDA). Spectral will also promptly submit a protocol amendment to the FDA, as recommended by the DSMB, for an additional exclusion criterion.
The EUPHRATES trial has continued to enrol patients and, as of April 11, 2014, 271 patients have been randomized.
"We are pleased with the positive outcome of the second interim analysis," said Dr. Paul Walker, President and CEO of Spectral. "The enthusiasm and support from our clinical trial sites has been outstanding. Based on current enrolment rates and number of sites, we anticipate completion of the trial in the first half of 2016."
PhoreMost and Plexxikon Collaborate to Identify Novel Drug TargetsNews
PhoreMost, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, today announced it has signed a collaborative agreement with Plexxikon Inc., the small molecule structure-guided R&D centre of Daiichi Sankyo.READ MORE
Anti-Malaria Drugs Delivered With CaffeineNews
Many drug delivery systems, such as capsules and tablets, can be difficult to swallow, especially for children. Making delivery systems out of polymer gels is an attractive option, but usually requires hazardous levels of heavy metals to be used. Now, scientists have found a way to build these gels from caffeine molecules.READ MORE
Lonza Opens World’s Largest Dedicated Cell-and-Gene-Therapy Manufacturing Facility in TexasNews
First-of-its-kind, state-of-the-art manufacturing facility with capacity to produce treatment for thousands of patients suffering from rare genetic disorders or life-threatening diseases.READ MORE