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Spherix Announces Post-Hoc Analysis of Phase 3 Trial With D-Tagatose in Diabetes
Date:12/2/2010

BETHESDA, Md., Dec. 2, 2010 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq: SPEX), an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis; and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced results from its first Phase 3 trial post hoc analysis in which the higher body mass index (BMI) of the U.S. population relative to the Indian population was a likely key contributor to the more positive effects of D-tagatose in the lowering of HbA1c levels in the U.S. population. Initial results were announced on October 7.

The first post hoc analysis done of the Biospherics Phase 3 NEET clinical trial suggests that the larger reduction in HbA1c observed in the Per Protocol population in the USA may be the result of D-tagatose acting at the level of metabolic control mediated by adipocytes (fat cells). In other words, in patients with sufficient numbers and size of adipocytes for dietary carbohydrate effects to be manifested, there is a role for adipocytes in the mechanism of D-tagatose in the control of blood glucose and plasma triglyceride levels.

"Tagatose appears to be more effective in Type 2 diabetes patients with adipocyte dysfunction that no longer permits the adipocytes to act appropriately as an endocrine organ controlling HbA1c," said Dr. Robert Lodder, President of Spherix.

Results from the first post hoc analysis of the Biospherics Phase 3 70971-004 clinical trial showed a correlation between HbA1c and BMI through all of the monthly visits (v1-v14) in the trial (see Table 1). Results of the Phase 3 trial, as previously reported, showed a greater lowering of HbA1c with tagatose treatment in patients from the US cohort (-1.1 vs. placebo at 10 months of therapy in the Per Protocol population) compared with India (-0.2 vs. placeb
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SOURCE Spherix Incorporated
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