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Isis Initiates Phase 1 Clinical Trial of SGLT2 Antisense Drug
Date:2/5/2009

ISIS-SGLT2Rx - Isis' first kidney-targeted antisense drug for type 2 diabetes enters clinical development

CARLSBAD, Calif., Feb. 5 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today it has initiated a Phase 1 study of ISIS-SGLT2Rx, an antisense drug that inhibits the production of sodium dependent glucose co-transporter type 2 (SGLT2). SGLT2 is the major transporter responsible for glucose re-absorption in the kidney. Decreasing SGLT2 levels promotes glucose excretion in the urine and reduces blood sugar levels, making it an attractive target for the treatment of diabetes. The Phase 1 study of ISIS-SGLT2Rx is a double-blind, placebo-controlled, dose-escalation study conducted in healthy volunteers and is designed to assess the safety and pharmacokinetic profile of ISIS-SGLT2Rx as well as to measure ISIS-SGLT2Rx's activity by evaluating its effect on glucose excretion in urine.

"In several preclinical models, we have demonstrated greater than 80 percent reduction of SGLT2 levels in the kidney at low-weekly doses, which resulted in significant increases in urinary glucose excretion. These changes were accompanied by robust and sustained decreases in blood glucose levels in diabetic animals as well as amelioration of diabetic complications such as cataract formation. Furthermore, ISIS-SGLT2Rx did not reduce blood sugar levels below normal," said Sanjay Bhanot, M.D., Ph.D., Vice President of Metabolic Diseases Research & Development at Isis. "We are encouraged by the preclinical activity of ISIS-SGLT2Rx and the high tissue-specificity observed for our first kidney-targeted drug."

"ISIS-SGLT2Rx is among the most potent antisense drugs Isis has yet evaluated in preclinical models. The enhanced potency we have observed supports the possibility of infrequent injectable dosing or
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SOURCE Isis Pharmaceuticals, Inc.
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