BELTSVILLE, Md., March 23 /PRNewswire-FirstCall/ -- Spherix Incorporated announced that its CEO, its BioSpherix Division Research Manager, and its consultant, ENVIRON International, Inc., just returned from overseas where they met with key staff members and inspected facilities of a clinical research organization. An agreement for a multi-national Phase 3 clinical trial of Spherix’s Naturlose(R) as a Type 2 diabetes drug is being finalized. Preliminary work is underway and patient recruitment is expected to begin before year-end.
Last November, the FDA approved the Phase 1 and Phase 2 clinical trial data submitted by Spherix, and authorized the Phase 3 clinical trial in December (see Spherix’s 12/6/05 press release). In January 2006, the Company placed an order with its manufacturer for bulk Naturlose to conduct the trials, and contracted with ENVIRON, a scientific consulting organization highly experienced in FDA regulatory work, to help plan and oversee the trials (see Spherix’s 1/10/06 press release). Diabetes is debilitating, widespread, and growing, now affecting more than 18.2 million people in the United States and 170 million people worldwide. Type 2 diabetes is the most common form of the disease.
The protocols for the Phase 3 trials are currently under design. While Spherix is prepared to complete the study on its own, it is investigating possible arrangements with a major drug company should one become interested in the trial. Such a company would be very important to the manufacture, promotion, distribution and sale of the product.
Certain statements contained herein are “forward looking” statements as defined in the Private Securities Litigation Reform Act of 1995. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied. Factors that could cause actual results to differ materially from those expressed or implied include, but are not limited to, those discussed in filings by the Company with the Securities and Exchange Commission, including the filing on Form 8-K made on March 3, 1999.
Under its motto, “A World of Solutions,” Spherix’s mission is to create value and increase shareholder wealth through innovations that benefit our clients and the human condition. Spherix offers innovations in information technology, knowledge management, and biotechnology.
Spherix’s Internet address is http://www.spherix.com.
Spherix Incorporated
CONTACT: Spherix Incorporated Investor Relations, +1-301-419-7877, orinfo@spherix.com
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