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Spherix Completes Enrollment in NEET, a Phase 3 Clinical Trial Evaluating an Oral Drug for Type 2 Diabetes
Date:1/12/2010

BETHESDA, Md., Jan. 12 /PRNewswire-FirstCall/ -- Spherix Inc. (Nasdaq SPEX), an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced the completion of patient enrollment in its global Phase 3 clinical trial NEET (70971-004), which is evaluating the safety and efficacy of D-tagatose as an oral treatment for Type 2 diabetes mellitus.  The company expects the efficacy results to be available as soon as mid-year, with the maintenance phase of the trial continuing through 2010.

Dr. Claire Kruger, Chief Executive Officer of Spherix commented, "This next year will potentially be the most exciting and gratifying time in our Company's history.  If successful and approved by the FDA, D-tagatose will offer a unique oral drug to improve glycemic control in Type 2 diabetes patients.  I am grateful for the hard work of our employees and contractors, which has allowed us to meet this significant milestone; however, much work remains to be done as we progress toward NDA filing."

The NEET (Naturlose (D-tagatose) Efficacy Evaluation Trial) is a global one-year, multi-center, placebo-controlled, double-blinded, randomized, parallel clinical study of 332 patients to evaluate the safety and effectiveness of D-tagatose on glycemic control in subjects with Type 2 diabetes under diet control and exercise.  The duration of the efficacy portion of the trial was reduced from twelve to six months in a protocol amendment submitted to the FDA last September.  The cardiovascular safety-testing portion of the trial totals twelve months.

In December 2008, after the initiation of the Phase 3 clinical trial by Spherix, the FDA issued a Guidance for Indust
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SOURCE Spherix Incorporated
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