Quigley Corporation Releases Update on Quigley Pharma's Phase IIb Clinical Study of QR-333 in Diabetic Peripheral ...( DOYLESTOWN Pa. Sept. 11 /- The Qu...)

DOYLESTOWN, Pa., Sept. 11 /PRNewswire-FirstCall/ -- The Quigley Corporation (Nasdaq: QGLY) today issued an update on a Phase IIb Clinical Study of QR-333 on Diabetic Peripheral Neuropathy by its wholly owned subsidiary, Quigley Pharma, http://www.QuigleyPharma.com.

The update on the study noted that over 100 subjects have been enrolled, 52 subjects have completed treatment and over 225 subjects have been screened for the Phase IIB study designed to evaluate the safety and efficacy of the topical formulation on subjects with diabetic peripheral neuropathy. Subject screening and enrollment will continue to ensure a 140 evaluable patient study population. Once enrolled, subject treatment time is 12 weeks. To date the in-progress safety profile for this study has been consistent with the findings from the favorable safety results of the previous human proof of concept study conducted in France.

The screening process for enrollment is one of the most crucial aspects of a clinical drug trial, with only the most relevant subject population being selected, thus preventing a compromise of the resultant data and ensuring an accurate measure of the drugs evaluation. Consistent with other diabetic peripheral neuropathy studies, the inclusion/exclusion criteria for this trial are very stringent.

The subjects must:

-- be stable in their diabetes (reflective of their blood glucose levels)

-- have a confirmatory diagnosis of diabetic peripheral neuropathy with a

demonstrated level of pain (40 out of 100 on a visual analogue pain

scale) significant enough to be able to gauge an improvement

-- not have other serious disea
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