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Naturlose A New Treatment for Diabetes Begins Phase 3 Trials

Dec 5, 2006
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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).

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FACT:
A modest reduction in salt intake in children causes immediate falls in blood pressure: To assess the effect of reducing salt intake on blood pressure in children, University of London researchers carried out a meta-analysis of controlled trials. Trials were included if participants were children (18 years), and duration of salt reduction must have been for 2 weeks. They found: When salt intake was reduced by 42%, there were significant reductions in blood pressure: systolic: –1.17 mm Hg (P<0.001); diastolic: –1.29 mm Hg (P<0.0001). Three trials of infants with 551 participants were included (median duration: 20 weeks; range: 8 weeks to 6 months). Salt intake was reduced by 54% (IQR: 51% to 79%). There was a significant reduction in systolic blood pressure: –2.47 mm Hg (P<0.01). The results demonstrate that a modest reduction in salt intake causes immediate falls in blood pressure and, if continued, may well lessen the subsequent rise in blood pressure with age. This would result in major reductions in cardiovascular disease. These results in conjunction with other evidence provide strong support for a reduction in salt intake in children.” Hypertension. 2006;48:861. November 2006. Importance of Salt in Determining Blood Pressure in Children – Meta-Analysis of Controlled Trials,