DOYLESTOWN, PA (October 18, 2005) Quigley Pharma, a wholly owned
subsidiary of the Quigley Corporation (NASDAQ: QGLY), announced today that two
pre-clinical toxicity studies of QR-333, a topical compound for the treatment
of diabetic neuropathy, was determined to be safe for topical application.
QR-333 is designed and formulated to significantly decrease the symptoms
associated with diabetic peripheral neuropathy.
The results of the first study conducted on hairless guinea pigs concluded that
there was no evidence of primary irritancy, photo toxicity, contact
hypersensitivity or photoallergy in response to topical administration of the
placebo or the QR-333 cream at a dose volume as high as 0.6 ml.
The second study conducted on Gottingen Minipigs revealed that there was
essentially no difference in the dermal response to either active or placebo
creams. The incidence and degree of the various parameters were similar in the
control and drug-treated groups. The results of the clinical observations that
included opthalmologic examinations, electrocardiograms, clinical pathology
studies and necropsy did not suggest any event that could be an indication of
an adverse systemic effect.
"Based on the strength of this safety data, we are hoping to secure the
permission of the FDA to begin a Phase II B study to develop the most
efficacious dose range of this topical compound on human patients diagnosed
with diabetic peripheral neuropathy," said Dr. Richard Rosenbloom, Chief
Operating Officer, Quigley Pharma.
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 patients who have had Type II diabetes for 25 years and 17 percent
who have had it for less than 4 years.
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
diversified natural health medical science company. Its Cold Remedy segment is
a leading marketer and manufacturer of the COLD-EEZEŽ family of lozenges, gums
and sugar free tablets clinically proven to cut the common cold nearly in half.
COLD-EEZE customers include leading national wholesalers and distributors, as
well as independent and chain food, drug and mass merchandise stores and
pharmacies. The Quigley Corporation has four (4) wholly owned subsidiaries.
Darius International markets health and wellness products through its wholly
owned subsidiary, InnerLight Inc. Quigley Manufacturing Inc. consists of two
FDA approved facilities to manufacture COLD- EEZE® lozenges as well as fulfill
other contract manufacturing opportunities. Quigley Pharma Inc.
(http://www.QuigleyPharma.com) conducts research in order to develop and
commercialize a pipeline of patented botanical and naturally derived
prescription drugs.
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.
