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Quigley Corporation Announces Final Results of Quigley Pharma's Phase IIb Study
Date:7/22/2009

12 weeks.

Number of patients (planned and analyzed):

The planned sample size of evaluable patients was 70 per arm (140 in total). Two hundred nineteen patients were randomized and enrolled; 109 and 110 patients were randomized to placebo and QR-333 treatment group, respectively.

Diagnosis and main criteria for inclusion:

Patients between the ages of 18 and 70 with a diagnosis of diabetic neuropathy were enrolled in the study.

Duration of treatment:

Treatment commenced at randomization (Visit 2) and continued for 12 weeks; study duration for each patient was approximately 22 weeks.

Endpoints:

Efficacy:

The primary efficacy objective is to demonstrate that treatment with QR-333 improves pain relief, as demonstrated through the VAS pain scale.

The secondary efficacy objective is to demonstrate that treatment with QR-333 improves symptomatic diabetic neuropathy, as demonstrated through the Symptom Assessment Score, Quality of Life questionnaires, and sleep questionnaires.

Safety:

Safety variables included adverse events (AEs), findings from physical and examinations, vital signs, laboratory safety data, 12-lead electrocardiograms (ECGs), and nerve conduction velocity (NCV) assessments.

About The Quigley Corporation

The Quigley Corporation (NASDAQ: QGLY, http://www.Quigleyco.com) is a diversified natural health medical science company. Its Cold Remedy segment is a leading marketer and manufacturer of the COLD-EEZE(R
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SOURCE Quigley Corporation
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