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The Quigley Corporation Updates Phase II Proof Of Concept Study For Diabetic Neuropathy Formulation

DOYLESTOWN, PA, July 24, 2002 - The Quigley Corporation (Nasdaq: QGLY) announced that the Phase II proof of concept study in France for its patent pending QR-333 formulation for the treatment of diabetic neuropathy is in progress.

The study pertains to the previously announced patent application, "Methods and Composition for Topical Treatment of Diabetic Neuropathy."

The study was delayed from its original start date in order to comply with recently enacted French importation laws requiring testing in France for ingredient safety of all imported drug formulae prior to clinical trials. This testing, required by French legislation enacted in response to post 9/11 concerns, has now been completed, with the safety of the ingredients in Quigley's QR-333 formulation certified by a government-authorized laboratory at The Quigley Corporation's expense.

The study is being conducted in France, an E.U. member country. After approval from the French Advisory Committee on the Protection of Research Subjects, The French Ministry of Health approved a Phase II Proof of Concept Study for the Treatment of Diabetic Neuropathy with Topical QR-333 on April 3, 2002. This multi-center, double blind, Placebo-controlled study is being conducted at three hospital sites in Bondy, Never and Le Gau-du-Roi, France.

In data compiled from 1995 to 1998, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) reported that diabetes afflicts approximately 17 million people in the United States (5.9% of the population) and that 798,000 new cases are diagnosed each year. Of the approximately 17 million patients, 50-70% would suffer from diabetic neuropathy, which may include pain or other disabilities.

The Company's new formulation for relief of diabetes-related pain is a topical treatment and its ingredients are all GRAS listed (Generally Regarded As Safe) as identified in the Code of Federal Regulations.

The Quigley Corporation (Nasdaq: QGLY) is a leading developer and marketer of diversified health products including the Cold-Eeze® family of patented zinc gluconate glycine (ZIGG™) lozenges, gums and sugar free tablets. Cold-Eeze is the only (ZIGG™) lozenge proven in two double-blind studies to reduce the duration of the common cold from 7.6 to 4.4 days or by 42%. In addition to Over-The-Counter (OTC) products, the Company has formed Quigley Pharma Inc. (www.quigleypharma.com), a wholly owned ethical pharmaceutical subsidiary, to introduce a line of patented prescription drugs. The Quigley Corporation's customers include leading national wholesalers and distributors, as well as independent and chain food, drug and mass merchandise stores and pharmacies.

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.

 

 
 
 
 


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