May 2 2007
Spherix Incorporated has announced that it has begun its Phase 3 clinical trial of Naturlose as a treatment for Type 2 diabetes.
The first participants have already been enrolled and the trial has begun. The remaining subjects continue to be enrolled in the United States and Australia for the trial, which is scheduled to finish testing in early 2009. Earlier, at an End of Phase 2 meeting with the Food and Drug Administration (FDA), the FDA accepted Spherix's "proof of concept" for Naturlose as a treatment for diabetes based on its preliminary efficacy and safety data, which indicated that the drug performs the desired function. The Company expresses high hopes that the fact that the compound has already been found GRAS (Generally Recognized As Safe) by the FDA means the frequent pitfall for new drugs, dangerous side reactions, will be avoided.
"This is a major step toward the successful commercialization of Naturlose," said Richard Levin, President and CEO of Spherix. "We've laid a solid foundation to conduct a scientifically sound trial, and I'd like to thank everyone in our BioSpherix Division and our corporate partners who have worked as a team to move the process along. The sale of our InfoSpherix subsidiary, currently scheduled to be completed by the end of the summer (see press release dated April 26, 2007), will come at the perfect time to strengthen the financial foundation of the trial and keep it on schedule."
In addition, the Company is testing several different manufacturing processes as part of satisfying the FDA's chemistry, manufacturing, and controls requirements for the Naturlose new drug application. Spherix has signed contracts and begun pilot plant design for a cGMP (current Good Manufacturing Practices) manufacturing facility to produce Naturlose.
The sale of the InfoSpherix subsidiary will make Spherix exclusively a biotech company with immediate resources to devote to the development and commercialization of Naturlose and other medical, health and environmental products. Dr. Gilbert Levin, inventor of the use of Naturlose as a drug, stated that, "Our first and persistent effort will be to complete the Phase 3 trial and enter Naturlose into the multi-billion dollar market for drugs effective against Type 2 diabetes."
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.