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Spectral Medical Inc
Symbol EDT
Shares Issued 179,737,241
Close 2015-03-09 C$ 0.66
Market Cap C$ 118,626,579
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Spectral's Euphrates trial gains DSMB recommendation

2015-03-10 08:06 ET - News Release

Dr. Paul Walker reports

SPECTRAL ANNOUNCES RESULTS OF DSMB MEETING; DATA SAFETY MONITORING BOARD RECOMMENDS CONTINUATION OF TRIAL AND AN ADDITIONAL INTERIM ANALYSIS

Spectral Medical Inc. has released the results of the Data Safety and Monitoring Board recent meeting and its recommendations to Spectral. The DSMB is an independent body of experts in the fields of clinical medicine, biostatistics and trial methodology, which functions via a charter approved by the U.S. Food and Drug Administration to review the accumulated data of Spectral's trial and to provide recommendations to the company on a regular basis.

Key recommendations of recent meeting:

  • The DSMB has recommended that the Euphrates trial proceed as planned.
  • The DSMB has also agreed that an interim analysis be performed on the patients randomized since the last protocol amendment with the amended exclusion criterion.

"We are very encouraged by these recommendations for the Euphrates trial," said Dr. Paul Walker, president and chief executive officer of Spectral. "The added exclusion criterion has focused our trial on a sicker group of patients. Clinical studies from Italy and Japan have shown that sicker patients with a higher mortality risk benefit the most from Toraymyxin therapy for endotoxin removal. Our current composite mortality rate suggests that the sample size needed to determine statistical significance could be significantly smaller than previously calculated due to the much higher event rate."

Spectral will now submit an amended statistical analysis plan to the FDA incorporating an interim analysis. The SAP will include stopping rules for safety and efficacy. This interim analysis will include only patients enrolled in the trial since implementation of the additional exclusion criterion in April, 2014, up to approximately the end of the third quarter of 2015, with results anticipated to be available late in the fourth quarter of 2015.

We seek Safe Harbor.

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