DOYLESTOWN, Pa., Nov. 20 /PRNewswire-FirstCall/ -- Quigley Pharma Inc., a wholly-owned subsidiary of The Quigley Corporation announced today that patient enrollment in a phase IIb multi center clinical study of QR-333 for the treatment of symptomatic Diabetic Peripheral Neuropathy (DPN) has commenced. The Phase IIb double blind multi-center study will evaluate the safety and efficacy of QR-333, as compared to placebo-treated patients. The active QR-333 Investigational New Drug and placebo have been prepared for shipment and will be available to clinical investigators to begin treatment starting in December.
The Phase IIb trial will evaluate the safety and efficacy of QR-333 applied three times daily compared to placebo-treated patients over 12 weeks. Efficacy will be determined by Symptom Assessment Scores, a Visual Analogy Scale (VAS), Quality of Life and Sleep Questionnaires. Safety will be determined by medical history, physical examination, vital signs, 12-lead ECG, laboratory tests and nerve conduction studies. The study will involve 150-200 randomized male and female patients with Type 1 & 2 diabetes, as defined by the ADA (American Diabetes Association) and distal symmetric diabetic polyneuropathy.
The Study Chairman is Dr. Philip Raskin, Professor of Medicine University of Texas Southwestern Medical Center at Dallas Texas. The study protocol was approved by the FDA as a part of Quigley Pharma’s IND submission and has been approved by the required Investigational Review Boards. The completion of the study is dependent upon enrollment rates that may affect the overall length of the study and the communication of its results.
About QR-333:
QR-333 is composed of concentrated and standardized nutrient based active compounds, dosed in a topical cream. It is designed to reduce oxidative stress and inflammation associated with Diabetic Peripheral Neuropathy. Although the exact method of action for QR-333 is unknown, the antioxidant and anti-inflammatory characteristics of its active compounds have been well established. DPN is among the most common complications of diabetes, resulting in pain and numbness, skin ulcers, constant pain or extreme sensitivity to stimulus that affects patient sleep, functioning and well being. The pain is often accompanied by unpleasant sensations of buzzing, burning or jolting.
The Quigley Corporation makes no representation that the US Food and Drug Administration or any other regulatory agency will allow this Investigational New Drug to be marketed. Furthermore, no claim is made that potential medicine discussed herein is safe, effective, or approved by the Food and Drug Administration. Additionally, data that demonstrates activity or effectiveness in animals or in vitro tests do not necessarily mean the formula test compound; referenced herein will be effective in humans. Safety and effectiveness in humans will have to be demonstrated by means of adequate and well-controlled clinical studies before the clinical significance of the formula test compound is known. Readers should carefully review the risk factors described in filings the Company files from time to time with the Securities and Exchange Commission.
About The Quigley Corporation
The Quigley Corporation 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. 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(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 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: Media Investor Relations Karen Pineman Carl Hymans G.S. Schwartz & Co. G.S. Schwartz & Co. 212.725.4500 212.725.4500 kpineman@schwartz.comcarlh@schwartz.com
The Quigley Corporation
CONTACT: Media, Karen Pineman, kpineman@schwartz.com, or InvestorRelations, Carl Hymans, carlh@schwartz.com, both of G.S. Schwartz & Co.,+1-212-725-4500, for The Quigley Corporation
