Quigley Corporation Announces Final Results of Quigley Pharma’s Phase IIb Study
DOYLESTOWN, Pa., July 22 /PRNewswire-FirstCall/ — Quigley Pharma Inc., a wholly-owned subsidiary of The Quigley Corporation (Nasdaq: QGLY) 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:
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.
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 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: 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(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.
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 firstname.lastname@example.org email@example.com
SOURCE Quigley Corporation