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.
Guy J. Quigley, Chairman, President and Chief Executive Officer of The Quigley
Corporation commented, "The results from this study were very encouraging in
that they indicate that our QR333 formula may help people with the very painful
condition of diabetic peripheral neuropathy. Efficacy of the proof of concept
study was evaluated by a quality of life questionnaire and symptom assessment."
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.
PLANS FOR SUBMISSION OF IND
Based upon the French Proof of Concept results, The Quigley Corporation is
preparing an IND for submission to the FDA to obtain permission to study and
develop the formula as a prescription drug. A patent application for this
formula was previously assigned to The Quigley Corporation.
No claims are being made for the potential medicine discussed
in this press release to be safe, effective, or approved by
the Federal Food and Drug Administration (FDA).
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(tm)) lozenges,
gums and sugar free tablets. Cold-Eeze is the only (ZIGG(tm))
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 results, 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.
