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Torrenzano Group |
The
Quigley Corporation |
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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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