BELTSVILLE, Md., Oct. 26 /PRNewswire-FirstCall/ -- Spherix Incorporated has successfully completed its dose range-finding study, allowing it to continue with its Phase 3 clinical trial of Naturlose as a treatment for type 2 diabetes (see Spherix news releases dated May 23, 2006, and August 10, 2006). The tests were done on human subjects to establish the appropriate dosage and timing to be used in the upcoming trial. The Company will now recruit patients for the trial, which will take place in Australia and the United States. Company officials expect that the first participants will begin the Phase 3 clinical trial by April 2007.
“The test results so far have been positive,” said Spherix President Richard Levin. “Not only did they determine the dose and timing for the trial, but the results corroborate what we have seen in smaller, previous tests -- that Naturlose has a beneficial effect on modulating postprandial blood glucose, an important factor in the treatment of Type 2 diabetes. We are moving forward with confidence that we have a scientifically sound foundation on which to complete the Phase 3 trial, and to anticipate a favorable outcome.”
Levin said that the Company’s recently announced settlement of a contract dispute (see Spherix’s PR released earlier today) in its reservations business will bolster its financial ability to support Naturlose. In that settlement, Spherix agreed to accept $6 million to end the longstanding legal dispute over the award of the National Recreation Reservation Service contract. Spherix intends to use a portion of that payment to support its efforts to develop Naturlose as a marketable product. Spherix believes these funds, along with existing cash, will ensure its ability to complete the Phase 3 clinical trial.
If the Phase 3 trial establishes that Naturlose is an effective treatment for diabetes, Spherix will prepare a New Drug Application (NDA) for presentation to the Food and Drug Administration (FDA). FDA approval would give Spherix the right to market Naturlose as a diabetes drug. Naturlose has already been shown to be safe.
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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