Unexpected Positive Finding Expands Potential for Quigley QR333 Drug for Diabetic Neuropathy; Findings Suggest Possible Disease
April 30 2009 - 7:00AM
PR Newswire (US)
DOYLESTOWN, Pa., April 30 /PRNewswire-FirstCall/ -- Quigley Pharma
Inc., http://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:QGLYNASDAQ: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(R) 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(R) 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 . 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.
CONTACT: Media Investor Relations Karen Pineman Carl Hymans G.S.
Schwartz & Co. G.S. Schwartz & Co. 212.725.4500
212.725.4500 DATASOURCE: Quigley Corporation CONTACT: Media, Karen
Pineman, , or Investor Relations, Carl Hymans, , both of G.S.
Schwartz & Co., +1-212-725-4500, for Quigley Corporation Web
Site: http://www.quigleyco.com/
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