Quigley Corporation Announces Final Results of Quigley Pharma's Phase IIb Study
July 22 2009 - 7:09AM
PR Newswire (US)
DOYLESTOWN, Pa., July 22 /PRNewswire-FirstCall/ -- Quigley Pharma
Inc., a wholly-owned subsidiary of The Quigley Corporation
(NASDAQ:QGLY) http://www.quigleyco.com/, today announced the
results from its Phase IIb double-blind, placebo-controlled, study
of topical compound QR-333 for the treatment of symptomatic
diabetic peripheral neuropathy. The study was completed with fewer
than expected evaluable patients with the final and comprehensive
conclusions revealing that (i) the compound is safe and well
tolerated, and (ii) there were nominal trends, but no statistical
differences, between active and placebo groups for the primary and
secondary endpoints measuring efficacy by (a) the reduction of
pain, (b) symptomatic improvements, (c) improved quality of life
and (d) improved sleep. However, the Company is encouraged by the
positive, clinical and statistically significant improvement for
efficacy in sural nerve conduction velocity and amplitude
unexpectedly found in a sub-set of the patient population,
announced in a press release on April 30, 2009. Those data may
indicate the potential benefit of this compound as a disease
modifying agent which, if validated through additional clinical
trials, potentially broadens the therapeutic market opportunity.
Additional clinical work would be required and future study
considerations might include, a longer duration period to improve
patient compliance as well as an assessment of sural nerve function
and measures of distal nerve sensory thresholds in the feet to
provide more detail to the potential for disease modification.
There can be no assurance the Company will undertake additional
clinical studies or that the results thereof would lead to a
marketable product that can achieve regulatory approvals. A
preliminary analysis of the lack of adequate primary and secondary
end point data indicates that the results may have been attributed
to fewer then expected evaluable patients due to a shortage of drug
and a high number of patients terminated early due to a lack of
compliance with application and usage protocols. "We have recently
hired an independent consultant to conduct a thorough review of the
entire research and development portfolio of potential products in
the Quigley Pharma pipeline," said Ted Karkus, CEO. "We will wait
for this review to be completed before determining the next steps
in the development of QR-333 and other formulations." All required
end of study regulatory and reporting documentation and procedures
will be completed. Consistent with previous announcements and
pending the full review of the product portfolio, the Company will
continue to consider licensing, partnering or collaborative
relationship opportunities to further the development and potential
commercialization of the QR-333 candidate and other formulations.
The ADA estimates that neuropathy occurs in up to 60-70% of
diabetics, and an estimated 5 million Americans are affected by
diabetic peripheral neuropathic pain. The World Health Organization
estimates that more than 171 million people have diabetes
worldwide, a figure that is expected to rise to 366 million by
2030. About the study: Methodology: This was a double-blind,
randomized, parallel-group, placebo controlled study conducted at
22 sites with 1 to 27 patients randomized per site. Patients
between the ages of 18 and 70 years with a diagnosis of diabetes
and symptoms of peripheral neuropathy were eligible for enrollment
into the study. Eligible patients were randomized to 1 of 2 groups
each applying study cream topically to the feet three times daily
(tid) with placebo or QR-333 for 12 weeks. Number of patients
(planned and analyzed): The planned sample size of evaluable
patients was 70 per arm (140 in total). Two hundred nineteen
patients were randomized and enrolled; 109 and 110 patients were
randomized to placebo and QR-333 treatment group, respectively.
Diagnosis and main criteria for inclusion: Patients between the
ages of 18 and 70 with a diagnosis of diabetic neuropathy were
enrolled in the study. Duration of treatment: Treatment commenced
at randomization (Visit 2) and continued for 12 weeks; study
duration for each patient was approximately 22 weeks. Endpoints:
Efficacy: The primary efficacy objective is to demonstrate that
treatment with QR-333 improves pain relief, as demonstrated through
the VAS pain scale. The secondary efficacy objective is to
demonstrate that treatment with QR-333 improves symptomatic
diabetic neuropathy, as demonstrated through the Symptom Assessment
Score, Quality of Life questionnaires, and sleep questionnaires.
Safety: Safety variables included adverse events (AEs), findings
from physical and examinations, vital signs, laboratory safety
data, 12-lead electrocardiograms (ECGs), and nerve conduction
velocity (NCV) assessments. 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 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. CONTACT: Ted
Karkus Media Investor Relations Chairman of the Board, CEO Karen
Pineman Carl Hymans The Quigley Corporation G.S. Schwartz & Co.
G.S. Schwartz & Co. (215) 345-0919 (212) 725-4500 (212)
725-4500 DATASOURCE: Quigley Corporation CONTACT: Ted Karkus,
Chairman of the Board, CEO of The Quigley Corporation,
+1-215-345-0919; or Media, Karen Pineman, , or Investor Relations,
Carl Hymans, , both of G.S. Schwartz & Co., +1-212-725-4500 Web
Site: http://www.quigleyco.com/
Copyright