BETHESDA, Md., Oct. 7 /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 that its Phase 3 study of D-tagatose as a monotherapy in Type 2 diabetes showed a statistically significant (p<0.05) reduction in HbA1c levels of 0.4% at 10 months in relatively healthy people with diabetes (U.S. ITT LOCF, n=101 and Global PP, n=92)*. The reduction was even more pronounced among PP patients treated in the U.S., and the reduction in HbA1c generally increased over the 10 months patients were treated (see Table 1).
The NEET (Naturlose® Efficacy Evaluation Trial) data show that D-tagatose was more effective in the U.S. population than in the Indian population, as the PP patients in the U.S. who were treated with Dtagatose had a reduction in HbA1c of 0.4% at two months, 0.6% at six months and 1.1% at 10 months on therapy (p<0.05).
Patients in the study had a low average randomization HbA1c of 7.5% globally. An HbA1c level of 6% or below is considered normal. An 8% level is considered high. The American Diabetes Association recommends a goal of reducing HbA1c to 7% or below in people with diabetes.
"These are promising results and we are pleased with the significant drop in HbA1c levels among patients treated with Dtagatose. As a monotherapy in a patient population with mild disease, this achievement is even more compelling," said Dr. Claire Kruger, Chief Executive Officer of Spherix. "We believe that further development in the Type 2 diabetes indication is merited, and we look forward to engaging a partner to continue this work."
John Amatruda, M.D., a drug-development executive who was
|SOURCE Spherix Incorporated|
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