Continuing Supplies Will Be Used For NDA and to Complete Current Phase 3 Trial of Naturlose(R) for Type 2 Diabetes
BETHESDA, Md., June 23 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq: SPEX), an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that it has received its first full-scale production batch of cGMP (FDA Current Good Manufacturing Practice) D-tagatose, USP (U.S. Pharmacopeia) grade. One metric ton of drug was received from the manufacturer, Inalco S.p.A., of Italy. Spherix will use the tagatose in the process of satisfying the CMC (Chemistry, Manufacturing and Control) requirements of its NDA (New Drug Application) to the U.S. FDA. This batch, as well as subsequent batches, will also be used in the on-going Phase 3 clinical trial evaluating the effectiveness and safety of Naturlose as a treatment for Type 2 diabetes.
"Receiving this delivery of D-tagatose from Inalco is a noteworthy event for Spherix as it signifies achievement of several important milestones," said Dr. Claire Kruger, CEO of Spherix. "First, it demonstrates the full-scale cGMP process will be used to produce drug for marketing purposes and for use by patients in our Phase 3 clinical trial. Second, as part of this process, a DMF (Drug Master File) has been submitted to the FDA and Spherix has a Letter of Authorization to refer to the DMF in its NDA. Finally, it demonstrates Spherix's ability to use multiple sources to deliver the high volume of doses of Naturlose(R) that would be needed to meet patient demands should we receive FDA approval. The Company has enough drug to complete all of its clinical trials involving Naturlose as a novel and natural option to treat Type 2 diabetes."'/>"/>
|SOURCE Spherix Incorporated|
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