Spherix Incorporated (NASDAQ:SPEX) reported that patient recruitment for its Phase 3 clinical trial of its potential type 2 diabetes drug, Naturlose(R), has begun in India. Expectations for India are to provide more than 300 patients spread across 35 sites for the pivotal Phase 3 trial. “Now that enrollment efforts are underway in India, we believe that the Phase 3 trial will be completed on schedule as reported during the May 2008 Annual Shareholders Meeting. This truly represents a tremendous amount of hard work, both internally and externally, to achieve regulatory approval and patient recruitment in such a short period of time,” said Randy W. Brown, Chief of Operations. Global enrollment is scheduled for completion by the end of the first quarter 2009, and the trial is scheduled to be completed in 2010. Spherix Incorporated also announced the signing of a contract with Amarex, a Contract Research Organization (CRO) located in Germantown, MD, to oversee the work of two India CROs hired to execute the trial in India. “It became quite clear that the trial was not executable solely in the United Sates with our known parameters; therefore, India became an obvious, viable solution. I now expect our ultimate deliverable, a new drug application, to be back on schedule,” said Mr. Brown.
