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."
Inalco, a global supplier/producer of lactulose, 2-deoxy-D-ribose, ampicillin, and amphotericin B headquartered in Milan, Italy, becomes the second manufacturer to supply Spherix with D-tagatose. The new batch was entered into the current Phase 3 clinical trial in the U.S. on June 18. Per FDA guidelines, any manufacturer that produces D-tagatose used successfully in a phase 3 trial will be allowed to supply that product to Spherix in the future should Naturlose be approved by the FDA as a pharmaceutical therapy. In addition to Inalco, Spherix has also received and dosed D-tagatose in patients participating in its Phase 3 trial from material supplied by SweetGredients.
Spherix holds patents on the use of Naturlose as a drug to treat diabetes. Naturlose is D-tagatose, which occurs naturally in small amounts in dairy products. It is a highly soluble white crystal or powder, can be produced with a physical bulk similar to ordinary table sugar, and is 92% as sweet. In the U.S., based on over 10 years of animal, human, and other relevant use and safety data, Naturlose qualified as Generally Recognized As Safe (GRAS) for use in foods under the FDA-regulated program. Naturlose has been formally approved as a "novel food ingredient" in the European Union (EU) without any restriction on usages.
About Type 2 Diabetes
Type 2 diabetes mellitus (T2DM) is a disease that is characterized by elevated blood glucose in the context of insulin resistance and comparative insulin deficiency. While T2DM is often initially managed by increasing exercise in conjunction with dietary modification, medications are usually needed as the disease progresses. There are an estimated 23.6 million people in the U.S. (7.8% of the population) with diabetes, and 17.9 million cases have been diagnosed. Of the diagnosed diabetes cases, 90% are type 2. As T2DM prevalence rates doubled between 1990 and 2005, the CDC characterized the increase as an epidemic. Customarily considered a disease of adults, T2DM is increasingly being diagnosed in children in correlation to increasing juvenile obesity rates.
Spherix Incorporated was launched in 1967 as a scientific research company, under the name Biospherics Research. The company now leverages its scientific and technical expertise and experience through its two subsidiaries -- Biospherics Incorporated and Spherix Consulting, Inc. Biospherics is currently running a Phase 3 clinical trial to study the use of Naturlose as a treatment for Type 2 diabetes. Its Spherix Consulting subsidiary provides scientific and strategic support for suppliers, manufacturers, distributors and retailers of conventional foods, biotechnology-derived foods, medical foods, infant formulas, food ingredients, dietary supplements, food contact substances, pharmaceuticals, medical devices, consumer products, and industrial chemicals and pesticides. For more information, please visit www.spherix.com.
This release contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this release, including statements relating to planned clinical study design, regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products, constitute forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of Naturlose, the FDA may interpret the results of studies differently than us, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends, our continuing efforts to develop Naturlose may be unsuccessful, our common stock could be delisted from the Nasdaq Capital Market, and other risks and challenges detailed in our filings with the U.S. Securities and Exchange Commission, including our current report on Form 8-K filed on October 10, 2007. Readers are cautioned not to place undue reliance on any forward-looking statements which speak only as of the date of this release. We undertake no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.
|SOURCE Spherix Incorporated|
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