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BSN175 Incorporated

Drug Names(s): Naturlose, D-tagatose, BSN 175

Description: BSN175 (Naturlose) is a naturally occurring stereoisomer of D-fructose. The drug is not well absorbed, and only 20% of orally ingested tagatose is fully metabolized, principally in the liver. In an early clinical study, the drug did not reduce blood glucose, but did blunt the increase in glucose after an oral glucose tolerance test (OGTT). It also reduced the increase in insulin after the OGTT in normal individuals, but not diabetics.

Proposed mechanisms of action include interference in the absorption of carbohydrates by inhibiting intestinal disaccharidases (enzymes that break pairs of sugars into individual sugar molecules) and glucose transport, as well as increasing glycogen storage. The latter is proposed to occur through inhibiting glycogen phosphorylase, the enzyme that metabolized glycogen, and promoting glucokinase, which metabolites glucose to glucose-6-P, stimulating its storage as glycogen.

D-tagatose is also proposed to lower VLDL and triglycerides by interfering with fructose metabolism.

Naturlose 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. Naturlose has an established safety profile as an artificial sweetener and has been recognized by the U.S. Food and Drug Administration (FDA) as a GRAS (Generally Recognized as Safe) substance for use in food and beverages since 2001.

Deal Structure: Spherix and Inalco
In April 2008, Spherix announced that it signed letters of intent with Inalco S.p.A. to supply a portion of the D-tagatose used in the Spherix Phase III clinical trial of the unique sugar as a treatment for Type 2 diabetes. Inalco will also provide cGMP (current Good Manufacturing Practice) production batches of D-tagatose for the Spherix New Drug Application (NDA) and will hold a Drug Master File (DMF). Financial terms were not disclosed.

Spherix and UKRF
In June 2010, Spherix announced that its wholly-owned subsidiary, Biospherics, has signed a license agreement with the University of Kentucky Research Foundation (UKRF). The agreement gives Biospherics the worldwide rights to international patents filed on behalf of UKRF for D-tagatose as a lipid-lowering agent for prevention and treatment of atherosclerosis, hypertriglyceridemia, and related dyslipidemias.Also included in the license are five unique drug formulations that include...See full deal structure in Biomedtracker

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