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Unexpected
positive finding expands potential for
Quigley QR333 drug for Diabetic
Neuropathy
Findings
suggest possible disease modification
Doylestown, PA (April 30,
2009) Quigley Pharma Inc., www.quigleyco.com, a
wholly-owned subsidiary of The Quigley Corporation (NASDAQ: QGLY) announced
today that their recently completed Phase 2 double-blinded, placebo-controlled,
clinical trial of diabetic peripheral neuropathy, demonstrated a significant
improvement in two key measures of distal sensory nerve function in the group
treated with QR333. The compound was applied topically to the feet of
subjects suffering from painful diabetic neuropathy and over the course of 12
weeks, it significantly improved both maximal conduction velocity (p=0.05) and
compound sensory amplitude (p=0.05) in the sural nerve. These are
well established, validated and objective electrophysiologic measures of the
onset and progression of diabetic nerve damage. The mean improvement
in nerve conduction velocity was 1.5 m/sec, which exceeds the change considered
by thought leaders to be “clinically meaningful” in clinical
studies. The sural nerve carries sensation from the feet and its
pathology is the fundamental cause of foot pain and ultimately foot ulcers and
amputation in some diabetic subjects.
The
positive findings were detected in compliant patients (approximately 50% of the
original intent to treat population) who had measurable nerve activity at both
the beginning and end of the study. A
more conservative analysis involving approximately 65% of the randomized
subjects showed a strong, but non-significant, trend toward benefit for the
QR333 treated group. Other nerves evaluated for safety purposes were
unaffected. The electrophysiology testing was done as a safety
measure and was of interest because of the topical application of the study drug
to the area of the sural nerve.
These
findings necessitate a change in the potential outlook for this investigational
new drug. The Diabetic Peripheral Neuropathy market has significant unmet need
for rational, mechanism-based drugs. These clinically significant
findings suggest disease modification in this (12 week) phase II (b)
study. The Company is aware that this is a finding in a subset of the
patient population.
Since the
observations obtained from the study relate to positive effect on nerve
functioning, we may, in the future, be focusing on a broader therapeutic
area.
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-EEZE®
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 several wholly owned subsidiaries; Quigley Manufacturing Inc.
consists of an FDA approved facility 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 potential prescription drugs.
Forward-Looking
Statements
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.
Important
Additional Information
The
Quigley Corporation (“Quigley” or the “Company”) filed a definitive proxy
statement with the Securities and Exchange Commission (the “SEC”) on April 2,
2009 in connection with the 2009 Annual Meeting of Stockholders and began the
process of mailing the definitive proxy statement and a WHITE proxy card to
stockholders. The Company’s stockholders are strongly advised to read Quigley’s
proxy statement as it contains important information. Stockholders may obtain an
additional copy of Quigley’s definitive proxy statement and any other documents
filed by the Company with the SEC for free at the SEC’s website at http://www.sec.gov.
Copies of the definitive proxy statement are available for free at
http://www.amstock.com/Proxy Services/ViewMaterial.asp?Co Number=07814. In
addition, copies of the Company’s proxy materials may be requested at no charge
by contacting MacKenzie Partners, Inc. at 1-800-322-2885 or via email at
quigley@mackenziepartners.com. Detailed information regarding the names,
affiliations and interests of individuals who are participants in the
solicitation of proxies of Quigley’s stockholders is available in Quigley’s
definitive proxy statement filed with SEC on April 2, 2009.