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Spherix Announces Statistically Significant Results in Phase 3 Study With D-tagatose in Type 2 Diabetes
Date:10/7/2010

formerly Senior Vice President and Franchise Head, Diabetes and Obesity, at Merck Research Laboratories and is now an advisor to Spherix, summarized clinical trial expectations.  According to Dr. Amatruda, "Decreases in HbA1c with drugs to treat Type 2 diabetes are dependent on the baseline HbA1c; the higher the baseline the greater the decrease (Bloomgarden et al, Diabetes Care, Volume 29 Number 9 September 2006).  Generally, one would not expect large decreases in HbA1c if the mean HbA1c at randomization is 7.5%."

Patients with HbA1c levels between 8.0% and 9.0% globally, which are at the high end of the inclusion criteria, showed 0.7% reduction on D-tagatose at 10 months of therapy (PP, not shown in table).  This occurred in a subpopulation of patients using the drug per protocol, but was not with statistical significance (p=0.09) due to the small number of patients (n=30) with HbA1c values at those levels.  "We are very encouraged by the response seen in patients with poorer control of blood sugar as measured by HbA1c in the NEET study," stated Dr. Robert Lodder, President of Spherix.

Tolerability data are still being analyzed, but the number of patients with one or more treatment-emergent adverse events in the active group (163) was comparable to those reported in the placebo group (166).  No serious adverse event was deemed to be treatment related. No episodes of hypoglycemia or pancreatitis were reported in NEET.

*PP = Per-Protocol; ITT = Intent-to-Treat; LOCF = Last Observation Carried Forward

Next StepsSpherix intends to submit a detailed analysis of the Phase 3 data to a peer-reviewed medical journal after the complete study report is received later this year.  Spherix will also post the final trial results on the public NIH ClinicalTrials.gov website as required by law.  In addition, Spherix will begin discussions with pharmaceutical companies and participate in two upcoming industry meeti
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SOURCE Spherix Incorporated
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