DOYLESTOWN, PA. - March 3, 2004 - The Quigley Corporation (Nasdaq: QGLY)
today announced that the results of its "Phase II Proof of Concept Study For
The Treatment of Diabetic Peripheral Neuropathy With Topical QR-333: A
Multi-Center, Double Blind, Placebo-Controlled Study," has been accepted for
presentation at the Diabetes 2004 Conference, March 23-27, 2004, in Nice,
France. The study concluded that subjects taking QR-333 had 67% of their
symptoms improve, strongly suggesting efficacy.
The Diabetes 2004 Conference is an annual symposium sponsored by ALFEDIAM, the
Association for French Language Studies of Diabetes and Metabolic Illnesses.
ALFEDIAM is an equivalent of the American Diabetes Association in France.
TRIAL DESIGN
The study used a total of 30 patients who were randomized into a double-blind,
placebo-controlled trial. It was a multi-center trial performed in France under
the direction of the Principal Investigator, Professor Paul Valensi, M.D.,
Hospital Jean Verdier, Service d'Endocrinologie, Avenue du 14 Juillet 93143
Bondy Cedex, France.
Efficacy was evaluated by use of the following instruments of evaluation:
Quality of Life questionnaire completed at: baseline, 2 weeks of treatment,
4 weeks of treatment, and 2 weeks post treatment.
Symptom Assessment completed at: baseline, 1 week of treatment, 2 weeks of
treatment, 4 weeks of treatment, and 2 weeks post treatment.
TRIAL RESULTS
Quality of Life:
After four weeks of treatment, the active group substantially outperformed the placebo group in thirteen out of
fourteen Quality of Life parameters.
Symptom Assessment:
Out of a total of 28 Symptom Assessment parameters, patients receiving the active formula fared substantially
better than those on placebo.
Certain key symptoms showed a substantially wider improvement ratio, suggesting that the active formula was
particularly effective for the following symptoms:
Irritation of the feet due to socks or sheets.
Numbness of the feet
Tingling of the feet.
Diabetes afflicts 15. 7 million people in the United States, according to data
compiled from 1995-1998 by the National Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK). According to the NIDDK, the data also found that 60 to
70 percent of diabetics suffer mild to severe forms of nervous system damage
and resultant pain, a condition known as diabetic peripheral neuropathy.
The Quigley Corporation (Nasdaq: QGLY), www.Quigleyco.com, is a leading
developer and marketer of diversified health products including the Cold-Eeze®
family of patented zinc gluconate glycine (ZIGG™) lozenges 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. (http://www.QuigleyPharma.com ), a wholly owned ethical
pharmaceutical subsidiary, to introduce a line of naturally-derived 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.
The Quigley Corporation makes no representation that the U.S. Food and Drug
Administration or any other regulatory agency will grant an IND or take any
other action to allow the aforementioned products to be studied or marketed.
Furthermore, no claim is made that the potential medicine discussed here 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 that 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.
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.
