BELTSVILLE, Md., Jan. 10 /PRNewswire-FirstCall/ -- Spherix Incorporated today announced that it has retained the services of ENVIRON International to help plan and oversee a Phase 3 clinical trial into the use of Naturlose as a treatment for people with Type 2 diabetes. A highly experienced consulting company with a staff of 700 and offices in the United States, Europe, Australia, and Asia, ENVIRON will assist Spherix with protocol development and selection of contract research organizations (CROs) to run the trial. It will also monitor performance and data. Upon successful completion of the trial, ENVIRON will assess the results and help Spherix prepare a “New Drug Application” for submittal to the FDA. Spherix and ENVIRON plan to hold meetings in the coming months to make final selections from the candidate CROs. Spherix has ordered 7 metric tons of Naturlose from the Firm’s licensed manufacturer for the trial.
The clinical trial, expected to begin later this year, could last as little as two years. More than 500 subjects from the United States and abroad will receive oral doses of Naturlose to test its ability to treat Type 2 diabetes. A Phase 3 clinical trial, which gathers evidence regarding effectiveness and safety, is needed to evaluate the overall benefit-risk relationship of new drugs proposed to the FDA. Because Naturlose has already been established as a substance “Generally Recognized as Safe” under FDA regulations, Spherix believes the elapsed time to approval should be shorter than that for most new drugs. A successful Phase 3 trial would permit Spherix to file a New Drug Application with the FDA, the approval of which would be the final step before marketing Naturlose as a diabetes-fighting pharmaceutical. The FDA generally decides on such applications within one year.
Previous Spherix-sponsored Phase 1 and Phase 2 clinical trials led by Thomas W. Donner, MD, Medical Director of the University of Maryland’s Joslin Diabetes Center, showed Naturlose to be a promising treatment for Type 2 diabetes. These results, reviewed by the FDA, were key to the FDA’s activation of Spherix’s Phase 3 status. Dr. Donner will participate as a consultant in the upcoming trial.
Diabetes affects more than 18.2 million people in the United States and more than 170 million worldwide. It is on the increase worldwide. Type 2 is the most common form; people with this chronic condition do not produce enough insulin, or their bodies cannot effectively use the insulin it produces. Untreated, diabetes is debilitating and life-threatening.
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 Investor Relations, +1-301-419-7877, or info@spherix.com
Web site: http://www.spherix.com//
