The BioSpherix Division of Spherix Incorporated (NASDAQ/SPEX), a technology firm headquartered in Beltsville, Maryland, today announced human clinical trials had begun to test Naturlose™, the Firm’s unique, naturally-occurring sugar, in fighting oral plaque. BioSpherix believes that the trials, being conducted by the University of Maryland School of Dentistry, will provide human validation of the Firm’s own laboratory tests[1] <#_ftn1> ,[2] <#_ftn2>. They demonstrated Naturlose’s ability to prevent oral bacteria from forming plaque, and to destroy any plaque already formed. The Firm’s revolutionary product is doubly patented for use as an active drug and as a low-calorie sweetener in drugs to increase their palatability.
In the clinical trials, people known to form dental plaque will be chosen as subjects. At the start of the trial, their plaque levels will be reduced to zero by mechanical dental procedures. Using FDA-approved plaque-measuring techniques, the investigators will monitor and compare the effects of a Naturlose mouth rinse, a water mouth rinse, and a standard plaque-reducing chemical mouth rinse on the teeth and gums. The subjects will not know which mouth rinse they are using. They will be instructed to use only the given mouth rinse, with no tooth brushing, flossing, or other plaque removal technique for the multiple test periods as prescribed by the University of Maryland School of Dentistry investigators. The tests will be performed to FDA standards.
If the results are as the Company expects, additional clinical trials will be run. The data, if supporting the earlier results, would then be submitted to the FDA for approval of Naturlose as a drug for use in oral hygiene products. The BioSpherix Division could then make claims that its recently developed[3] <#_ftn3> mouthwash and toothpaste formulations made with Naturlose prevent and destroy plaque and attack the common gum disease of gingivitis. The Company could offer those products for license, or could license and sell Naturlose, itself, to oral care manufacturers for use in their own brands. Spherix has patents pending for these uses. Naturlose is already approved as “non-cariogenic” by the FDA.
Dr. Gilbert V. Levin, Spherix’s Executive Officer for Science, said, “This is a very important development in line with our newly declared business plan to invest in hastening the commercialization of the higher value applications of Naturlose. This same strategy prompted the research project[4] <#_ftn4> we funded at the Albert Einstein College of Medicine to determine whether Naturlose might increase the shelf life of blood, blood components, and medicinal proteins as independently reported by researchers at this leading blood research institution. Success in either of these endeavors will elevate Naturlose to a new order of value. We are currently considering additional clinical trials with various research institutions and universities for other significant medicinal properties that we have patented for Naturlose.”
There has been much recent emphasis[5] <#_ftn5> on the importance of preventing and removing dental plaque to protect the teeth and gums, and, thereby, to ward off serious oral disease. Furthermore, plaque in other parts of the body has been implicated in a variety of other health problems. Animal and human studies of Naturlose, that established it as a substance Generally Recognized As Safe (GRAS) under U.S. FDA regulations, indicated a number of drug properties[6] <#_ftn6> for the simple, but rare natural sugar. Spherix initially developed it for its low-caloric properties and its table sugar-like taste. Spherix licensed its product for use as a sweetener in foods and beverages to Arla Foods of Denmark, which sells it under the brand name Gaio-tagatose® to brand food product manufacturers, including PepsiCo (in Diet Pepsi Slurpee’s), and to a variety of companies incorporating the sweetener into beverages, chocolate confections and other products.
Spherix retains the rights to all non-food uses of its extraordinary discovery. Several of these applications are under active development by the BioSpherix Division, operating in its new laboratory and office facilities in Annapolis, Maryland. Dr. Levin continued, “Our university research adds great strength to our Division, freeing our scientists to explore new applications of our technology. It also permits them to support the Division’s efforts to sell Naturlose as a sweetener to oral care, pharmaceutical, and cosmetic companies for use in their products. We recently sold[7] <#_ftn7> Naturlose to a major U.S. pharmaceutical company for clinical trials, which, if successful, could result in the product’s first pharmaceutical use.”
Richard C. Levin, a veteran Spherix Officer recently elected as CEO and President, said “The placement of clinical trials and other research activities in major universities is part of our plan to jump-start the BioSpherix Division into a highly value-added position. We believe that success of these studies will attract pharmaceutical companies and other organizations to fund the costly New Drug Application procedures required to gain FDA approval for drug uses. This would permit the BioSpherix Division to become a virtually independent, self-supporting company.”
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.
Our Internet address is http://www.spherix.com.
[1] <#_ftnref1> . Lu, Y. and G. Levin, “Removal and prevention of dental plaque with D-tagatose,” Int. J. Cos. Sci. 24, 225-234, 2002.
[2] <#_ftnref2> . Lu, Y, “D-Tagatose, a Novel Humectant and Sweetener for Toothpastes,” Cosmetics & Toiletries 116, 5, 95-100, 2001.
[3] <#_ftnref3> . Spherix Incorporated Press Release, “Spherix Shareholders Elect Board Members; Prototype Samples of Naturlose™ Toothpaste and Mouthwash Unveiled,” May 20, 2004.
[4] <#_ftnref4> . Spherix Incorporated Press Release, “Naturlose May Extend Blood Shelf Life,” July 22, 2004.
[5] <#_ftnref5> . “Strategies For Combating Bacterial Biofilm, A Leading Cause Of Gum Disease, Explored At IADR Symposium,” http://news.biocompare.com/newsstory.asp?id=71401 , March 14, 2005. [6] <#_ftnref6> . Levin, G.V., “Tagatose, the New GRAS Sweetener and Health Product,” Journal of Medicinal Food 5, 1, 23-36, 2002.
[7] <#_ftnref7> . Spherix Incorporated Press Release, “Spherix Announces First Sale of Naturlose™ for Pharmaceutical Use,” October 14, 2004.