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Spherix Announces Positive Phase 2 Study Results
Date:6/24/2009

l). The LDL:HDL ratio was improved for two of the three dose groups by an average of 0.3.

"The results of this ongoing Phase 2 study are encouraging and reaffirm our belief that Naturlose may be a valuable treatment option for patients with Type 2 diabetes," said Dr. Claire Kruger, CEO of Spherix. "Naturlose, administered at three separate low doses, proved to be effective for at least 6 months in reducing HbA1c, a key indicator of Type 2 diabetes that monitors glycated hemoglobin in the blood. These data, combined with the fact that Naturlose is a naturally occurring compound with no known contraindications to current Type 2 diabetes treatments, continues to lead us to believe that there will likely be a place for Naturlose in the treatment regime as either a stand-alone or an adjunct therapy. In addition, the effect on serum lipoproteins may lead to a role for Naturlose in the treatment of atherosclerosis and the metabolic syndrome."

Phase 2 Study Design

This phase 2 single-blind, prospective, randomized, multicenter study evaluated the minimum oral dose of Naturlose capable of causing a beneficial effect on HbA1c, and the safety of such doses. Naturlose was administered orally with meals (TID) at three different doses, 2.5, 5.0, and 7.5 g. Patients were required to pass specific inclusion criteria at screening and at baseline, including an HbA1c level at screening and baseline between 6.6% and 9.0%. The baseline visit followed an 8-week run-in period in which patients were instructed to follow a weight-maintaining diet and a daily exercise program under the supervision of the investigator. The run-in period was designed to compensate for the effect of diet and exercise on the estimated effectiveness of the drug. The treatment duration was six months and 38 patients have been randomized to one of the three doses to date. Patients with a current or recent history (within the prior 3 months) of treatme
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SOURCE Spherix Incorporated
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