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 diseases which would confound the data
-- not be on other medications which would confound the data
-- not so advanced in their neuropathy that they are not capable of
Although the Company believes enrollment should be completed before year end 2007, based on the protocol and stringent criteria submitted to the FDA, it is difficult to predict exactly when the study will be completed.
Currently in the United States, there are approximately 20,000,000 people with Diabetes. Of this population, nearly one half have or will have the symptoms of Peripheral Neuropathy. The company believes that a safe and effective topical product approved by the FDA as a "first line" treatment for diabetic peripheral neuropathy could develop a significant market position in a growing therapeutic category currently dominated by systemic therapies.
The Quigley Corporation makes no representation that the US Food and Drug Administration or any other regulatory agency will allow this Investigational New Drug to be marketed. Furthermore, no claim is made that potential medicine discussed herein is safe, effective, or approved by the Food and Drug Administration. Additionally, data that demonstrates activity or effectiveness in animals or in vitro tests do not necessarily mean the formula test compound; referenced herein will be effective in humans. Safety and effectiveness in humans will have to be demonstrated by means of adequate and well-controlled clinical studies before the clinical significance of the formula test compound is known. Readers should carefully review the risk factors described in filings the Company files from time to time with the Securities and Exchange Commission.
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) family of lozenges, gums and sugar free tablets clinically proven to cut the common cold nearly in half. COLD-EEZE customers include leading national wholesalers and distributors, as well as independent and chain food, drug and mass merchandise stores and pharmacies. The Quigley Corporation has several wholly owned subsidiaries. Darius International markets health and wellness products through its wholly owned subsidiary, InnerLight Inc. Quigley Manufacturing Inc. consists of two FDA approved facilities to manufacture COLD-EEZE(R) lozenges as well as fulfill other contract manufacturing opportunities. Quigley Pharma Inc. (http://www.QuigleyPharma.com) conducts research in order to develop and commercialize a pipeline of patented botanical and naturally derived prescription drugs.
Certain statements in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and involve known and unknown risk, uncertainties and other factors that may cause the Company's actual performance or achievements to be materially different from the results, performance or achievements expressed or implied by the forward-looking statement. Factors that impact such forward-looking statements include, among others, changes in worldwide general economic conditions, changes in interest rates, government regulations, and worldwide competition.
|SOURCE The Quigley Corporation|
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