DOYLESTOWN, PA (September 7, 2005) Quigley Pharma, a wholly owned
subsidiary of Quigley Corporation (NASDAQ: QGLY), announced today that a
preliminary report of QR-333, a topical compound for the treatment of diabetic
neuropathy, was recently featured in the Journal of Diabetes and Its
Complications. Authored by Dr. C. LeFante and Dr. P. Valensi, the article
appeared in the June 1, 2005 issue, and included findings that showed QR-333
reduced the severity of numbness, jolting pain, and irritation from baseline
values.
According to estimates from the American Diabetes Association, in 2001, 5.9
percent of US adults (15.7 million) have diabetes and an additional 6.9 percent
(13.4 million) have impaired glucose tolerance. Longstanding diabetes increases
the risk for an array of chronic health problems, and diabetic neuropathy is
the most common form of peripheral nerve damage, affecting approximately 53
percent of patient who have had Type II diabetes for 25 years and 17 percent
that have had it for less than 4 years.
"Studies suggest that painful diabetic peripheral neuropathy occurs in
about 45 to 54 percent of all diabetes patients," said Dr. Richard
Rosenbloom, Chief Operating Officer, Quigley Pharma. "The pain of diabetic
neuropathy can be managed, but at present, no therapy for diabetic neuropathy
itself is completely effective or without significant side effect
concerns."
Quigley Pharma's QR-333 is a topical compound designed and formulated to
decrease the oxidative stress that contributes to peripheral diabetic
neuropathy and thus alleviate its symptoms. This proof-of-principle study
assessed the efficacy and safety of QR-333 against placebo in a small cohort of
patients with diabetic neuropathy.
The published preliminary report detailed the study design, patients,
treatment, efficacy, safety, results and discussion. Trial results proved to be
significant. QR-333 reduced the severity of numbness, jolting pain, and
irritation from baseline values. Improvements were also seen in overall and
specific quality-of-life measures. QR-333 was well tolerated. Eleven patients
in the QR-333 group reported 23 adverse events (all mild or moderate); 4 in the
placebo group reported 5 events (all moderate). One patient who applied QR-333
noted a pricking sensation twice, the only adverse event considered possibly
related to study treatment.
"We're pleased with the preliminary safety study findings," added
Rosenbloom. "We conclude, as do the abstract authors, that QR-333 may
safely offer relief of symptoms of diabetic neuropathy and improve quality of
life, and that the findings warrant further investigation of this topical
compound."
The Quigley Corporation is the leading developer and marketer of diversified
health products. The company's proven success in launching first-in-category
health solutions supports the Pharma subsidiary in its efforts to develop
strong pharmaceutical compounds targeting diverse conditions such as diabetes
and rheumatoid arthritis with naturally derived compounds and botanicals.
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 compound 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.
About The Quigley Corporation
The Quigley Corporation (Nasdaq: QGLY, http://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. In October of 2004, The Company, through its wholly owned subsidiary,
Quigley Manufacturing, Inc. acquired two FDA approved facilities to manufacture
its COLD- EEZE® branded lozenges. InnerLight Inc., a wholly owned subsidiary,
was formed in December 2000 for the purpose of introducing new products to the
marketplace through a network of independent distributors. 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.
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.
