BELTSVILLE, Md., Dec. 6 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq: SPEX - News) today announced that yesterday it received confirmation from the U.S. Food and Drug Administration (FDA) that it has cleared the way for the Company to conduct a Phase 3 clinical trial of Naturlose(TM) to treat Type 2 diabetes. A successful Phase 3 trial would permit the Company to file a New Drug Application (NDA), the final step before marketing its patented product.
In a November 4 meeting with Spherix scientists and consultants, the FDA said that its Center for Drug Evaluation and Research had reviewed pharmacological, toxicological, and efficacy data from Spherix’s completed Phase 1 and 2 clinical trials, and found Naturlose to be qualified for the Phase 3 trial. At the meeting, FDA officials also reviewed the Phase 3 trial protocol recently submitted to the Agency by the Company, and made helpful suggestions.
“The World Health Organization (WHO) estimates that at least 171 million people worldwide have diabetes, a number the WHO expects to double by 2030,” said Dr. Gilbert V. Levin, Executive Officer for Science and Director of the Company’s BioSpherix Division. He added, “according to the Centers for Disease Control and Prevention, 20.8 million Americans have diabetes, nearly one-third of whom have not yet been diagnosed. By any measure, this is a huge and growing healthcare problem. Having an active Investigational New Drug for diabetes treatment is a major step for Spherix. We are now selecting a contract research organization to start the critical Phase 3 trial. Should all go well with the trial, we will file an NDA to enter Naturlose into the diabetes drug market to help combat this global health threat.”
Two Spherix-sponsored clinical trials led by Dr. Thomas Donner, Medical Director of the University of Maryland’s Joslin Center for diabetes, showed Naturlose to be a promising treatment for Type 2 diabetes. The studies were conducted at the University of Maryland School of Medicine.
Naturlose is also being developed for other medical and health uses. Last week Spherix began funding a second year of its research at the Albert Einstein College of Medicine (AECOM) to develop the use of Naturlose to preserve hemoglobin and other blood components, including platelets and various medicinal proteins. AECOM is one of the world’s leading blood research institutions. Spherix and AECOM recently (Spherix News Release, 11/3/05) entered into an agreement for the commercial development and sales of the anticipated products of their joint research.
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.
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.
Source: Spherix Incorporated
