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FDA approves changes to Spectral's septic shock trial
September 26, 2012 / 12:51 PM / 5 years ago

FDA approves changes to Spectral's septic shock trial

(Reuters) - Spectral Diagnostics Inc said the U.S. health regulator approved a change in the design of a late-stage trial of its therapy for septic shock, to increase the study’s ability to detect the treatment’s effects.

The trial, named EUPHRATES, will now have two interim analyses instead of one.

It tests the company’s Toraymyxin, which has been approved for therapeutic use in Japan and Europe, combined with the standard of care.

The company expects the trial to be fully enrolled by the end of 2014.

Septic shock is a potentially dangerous fall in blood pressure because of the presence of bacteria.

Based on the current rate of enrolment, Spectral will disclose results of the first analysis before the end of the first quarter of 2013, it said in a statement.

Shares of the company closed at 24.5 Canadian cents on Tuesday on the Toronto Stock Exchange.

Reporting by Shounak Dasgupta in Bangalore; Editing by Sriraj Kalluvila

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