Patient enrollment in Spherix's global Phase 3 clinical trial NEET completed

Jan 12 2010

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 Industry(1) which held that sponsors of diabetes drug trials should demonstrate that the therapy will not result in an unacceptable increase in cardiovascular risk.  The FDA has further stated(2) that the duration of the controlled phase in an efficacy trial is an important issue.  In studies of recently approved products that lasted more than one year, sponsors have typically conducted a randomized, controlled study lasting at least six months, followed by an extension phase lasting six months or longer.  In the protocol amendment submitted to the FDA last September, Spherix implemented the six-month randomized, controlled study followed by an extension phase lasting six months to establish the cardiovascular safety of D-tagatose in the treatment of Type 2 diabetes.

Dr. Robert A. Lodder, President of Spherix, noted, "Completion of enrollment in the Phase 3 clinical trial moves Spherix further down the path toward NDA filing.  In addition, the recent signing of a long-term supply agreement for D-tagatose with our DMF (Drug Master File) holder assures that the necessary supply of the drug will be available to Spherix.  Our global Phase 2 trial (70971-005) to determine the minimum dose of D-tagatose affecting the primary and secondary endpoints is progressing rapidly as well.  This single-blind trial offers the Company a valuable opportunity to study the effect of D-tagatose on multiple parameters as the study unfolds. Spherix is pleased with the progress of the drug development process."