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Arcion Therapeutics' Topical Gel Candidate, ARC-4558, Demonstrates Significant Pain Reduction in Phase 2b Trial for Painful Diabetic Neuropathy (PDN)
Date:7/20/2010

low or undetectable.  No serious or severe adverse events were attributable to ARC-4558 treatment and the topical formulation was well-tolerated at the site of skin application.  

"The top-line data reported today for ARC-4558 provide strong support for Arcion's fundamental approach of applying therapies topically to relieve neuropathic pain by targeting nerve signaling at the level of the skin," said James Campbell, M.D., President and CEO of Arcion. "Through this study, we identified a simple, predictive clinical test to identify non-responders to ARC-4558, which should enable us to optimize subject enrollment in future studies.  Based on our successful End of Phase 2 meeting with the FDA, we believe ARC-4558 will be the first PDN treatment indicated to treat patients who have demonstrable functional nociceptors in the skin.  The full Phase 2b results will be submitted for future peer review and we look forward to advancing the ARC-4558 program in Phase 3 studies."

Michael C. Rowbotham, M.D., Adjunct Professor of Neurology and Anesthesia and Director, UCSF Pain Clinical Research Center, commented, "Painful diabetic neuropathy is frequently a debilitating condition that severely impacts a patient's quality of life and ability to carry out normal day-to-day functions.  There are approved therapies to control the pain, but issues of tolerability and efficacy seriously limit their usefulness.  A novel mechanism-based topical treatment with a low liability of systemic side effects has promise to advance significantly the treatment of this condition and improve the quality of life for a large number of patients."

About the Phase 2b Trial

The Phase 2b study included an adaptive trial design and enrolled a total of 180 adult patients with PDN. Pati
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SOURCE Arcion Therapeutics, Inc.
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