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Naturlose A New Treatment for Diabetes Begins Phase 3 Trials

Posted: Thursday, December 07, 2006

Naturlose has a beneficial effect on modulating postprandial blood glucose.

Spherix Incorporated (SPEX) completed its dose range-finding study, allowing it to continue with its Phase III clinical trial of Naturlose as a treatment for type 2 diabetes.

The tests were done on human subjects to establish the appropriate dosage and timing to be used in the upcoming trial. The company will now recruit patients for the trial, which will take place in Australia and the United States.

Company officials expect that the first participants will begin the Phase III clinical trial by April 2007.

"The test results so far have been positive," said Spherix President Richard Levin. "Not only did they determine the dose and timing for the trial, but the results corroborate what we have seen in smaller, previous tests - that Naturlose has a beneficial effect on modulating postprandial blood glucose, an important factor in the treatment of Type 2 diabetes.

If the Phase III trial establishes that Naturlose is an effective treatment for diabetes, Spherix will prepare a New Drug Application (NDA) for presentation to the Food and Drug Administration (FDA).

Source: Diabetes In Control: Obesity & Diabetes Week 11/21/2006