BETHESDA, Md., July 14 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq: SPEX) reported that the Phase 3 clinical trial of its potential type 2 diabetes drug, Naturlose(R), will expand outside of the United States. Several countries with high prevalence of treatment-naive type II diabetics are being considered. "This expansion abroad should allow us to finish enrollment in the first quarter of 2009, which is consistent with the timeline reported at the recent Shareholders Meeting. What makes the sites we are considering so attractive is their ability to gain regulatory approval and recruit a large number of patients in a very short period of time," said Randy W. Brown, Chief of Operations. Mr. Brown reported that, as of June 30, 2008, 155 subjects of the required 450 have been randomized into the trial and are under study.
Recent media reports in the U.S. about the Phase 3 trial have accelerated inquiries by prospective patients who would like to participate in the trial. Stories appeared in Maryland's Baltimore Sun and on Pittsburgh, Pennsylvania's KDKA following publication of a report in the peer-reviewed journal Diabetes, Obesity And Metabolism(1-3). Thomas Donner, M.D., medical director of University of Maryland's Joslin Diabetes Center, said that if the drug works on diabetes, there could be more trials to show efficacy in weight reduction. Dr. Donner has noted that people in previous smaller trials also lost weight.
The Company also announced that it has successfully petitioned the FDA to eliminate the need for pre-mixed solutions for the delivery of study medicine to participants. "This convenient form of dosing reflects the expected delivery method of Naturlose once it gains approval. The change is expected to enhance recruitment and compliance in the trial. This is a significant advancement for the Company, our investigators and their patients," said Mr. Brown.
1. Yongming Lu, Gilbert Levin, Thomas Donner. "Tagatose, a New Anti-Diabetic and Obesity-Control Drug." Diabetes, Obesity and Metabolism. 10, 2008, 109-134.
2. Meredith Cohn, "Sweet Hope, The natural sugar tagatose, once a Slurpee sweetener, could help diabetes patients control blood glucose levels." Baltimore Sun, March 27, 2008.
3. Sugar Treatment Could Help Diabetes Patients, Jun 30, 2008 8:21 pm US/Eastern, http://kdka.com/health/sugar.diabetes.Tagatose.2.760164.html (click on "Related" to watch the video).
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 October 10, 2007.
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 biotechnology, and provides technical and regulatory consulting services to biotechnology and pharmaceutical companies.
Spherix's Internet address is http://www.spherix.com.
|SOURCE Spherix Incorporated|
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