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."

SOURCE Spherix Incorporated