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Arcion Therapeutics' Topical Pain Candidate, ARC-4558, Significantly Reduces Pain Caused by Diabetic Neuropathy
Date:5/7/2009

-Clinical Data Presented at American Pain Society Annual Meeting-

BALTIMORE, May 7 /PRNewswire/ -- Arcion Therapeutics, Inc., a venture backed clinical stage biotechnology company that develops pain therapies, today announced the presentation of data demonstrating that its lead candidate, ARC-4558, significantly reduced pain caused by diabetic neuropathy in a double-blind, placebo-controlled trial. The abstract will be presented in a poster session on May 8th from 4:00-5:30 PM at the American Pain Society Annual Meeting, held May 7-9 in San Diego. ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride for topical administration. Arcion is currently conducting a Phase 2b clinical trial of ARC-4558 for the treatment of painful diabetic neuropathy (PDN).

According to the abstract, patients receiving 0.1% clonidine gel reported significantly greater reductions in pain when compared to placebo (p=0.015). This improvement was demonstrated in the first week of the study (p=0.003). Participants in the 0.2% group did not differ from those in the placebo group, though a trend was observed (p=0.054). The 0.2% results may have been due to the fact that this group received 23% less gel in order to avoid higher systemic dosing. Consistent with this, clonidine blood levels in the 0.2% group were the same as that in the 0.1% group. Responder analysis revealed that 47.2% of patients across both treatment groups combined had 30% or more pain relief compared to 29.3% in the placebo group (p=0.031). Blood levels of clonidine varied from non-detectable to levels several-fold below the threshold required to treat hypertension (the original indication for clonidine). Patients with detectable clonidine in the blood experienced significantly greater pain reduction than patients in whom clonidine was not detected (p<0.05).

"These data demonstrate that ARC-4558 may offer a new approach to treating the pain associated wit
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SOURCE Arcion Therapeutics, Inc.
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