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Unexpected Positive Finding Expands Potential for Quigley QR333 Drug for Diabetic Neuropathy; Findings Suggest Possible Disease Modification
Date:4/30/2009

DOYLESTOWN, Pa., April 30 /PRNewswire-FirstCall/ -- Quigley Pharma Inc., www.quigleyco.com, a wholly-owned subsidiary of The Quigley Corporation (Nasdaq: QGLY) announced today that their recently completed Phase 2 double-blinded, placebo-controlled, clinical trial of diabetic peripheral neuropathy, demonstrated a significant improvement in two key measures of distal sensory nerve function in the group treated with QR333. The compound was applied topically to the feet of subjects suffering from painful diabetic neuropathy and over the course of 12 weeks, it significantly improved both maximal conduction velocity (p=0.05) and compound sensory amplitude (p=0.05) in the sural nerve. These are well established, validated and objective electrophysiologic measures of the onset and progression of diabetic nerve damage. The mean improvement in nerve conduction velocity was 1.5 m/sec, which exceeds the change considered by thought leaders to be "clinically meaningful" in clinical studies. The sural nerve carries sensation from the feet and its pathology is the fundamental cause of foot pain and ultimately foot ulcers and amputation in some diabetic subjects.

The positive findings were detected in compliant patients (approximately 50% of the original intent to treat population) who had measurable nerve activity at both the beginning and end of the study. A more conservative analysis involving approximately 65% of the randomized subjects showed a strong, but non-significant, trend toward benefit for the QR333 treated group. Other nerves evaluated for safety purposes were unaffected. The electrophysiology testing was done as a safety measure and was of interest because of the topical application of the study drug to the area of the sural nerve.

These findings necessitate a cha
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SOURCE Quigley Corporation
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