DOYLESTOWN, Pa., Aug. 21 /PRNewswire-FirstCall/ -- Quigley Pharma, a wholly-owned subsidiary of The Quigley Corporation announced today that the Company has been assigned Patent No. US 7,083,813 B2, for its application “Methods For The Treatment of Peripheral Neural and Vascular Ailments” filed in November of 2002. This adds another degree of intellectual property (“I.P.”) support to its lead investigational new drug QR-333 currently in Phase II clinical trials.
The Company filed the patent application based upon observations that subjects participating in the Proof of Concept Study conducted in France using the QR-333 compound had further improvements over and above the existing protocol. A significant observation regarding the improved color of study patient’s feet led the Company to conclude that the topical application of the QR-333 compound may have led to improved peripheral circulation.
Subsequently an immediate data search evaluating the active ingredients indicated that they indeed could have the potential to impact upon the human circulation system as vasodilators. This important new information provided the rationale for the Company to file a separate patent application to protect the Company’s Intellectual Property and allow it to study this further therapeutic benefit.
“The possibility of developing a drug that not only relieves the symptoms of diabetic peripheral neuropathy, but also improves circulation, would fulfill a significant therapeutic need,” stated Dr. Richard Rosenbloom, the COO of Quigley Pharma.
Among the 15 claims cited in the patent are “methods of treating patients having diabetic neuropathy with various effective topical formulation options that can be administered for treating peripheral neural ailments, such as decreasing pain, decreasing tingling, normalizing sensitivity to heat or cold, decreasing cramping, decreasing muscle weakness, decreasing numbness and improving peripheral circulation.” These are medically recognized as significant improvements to patients suffering from this disease state.
The first of two human clinical trials on QR-333 began in May after a FDA review of the IND application for the compound. QR-333 is designed and formulated to decrease oxidative stress that can contribute to the relief of symptoms associated with diabetic peripheral neuropathy.
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 Karen Pineman G.S. Schwartz & Co. 212.725.4500 kpineman@schwartz.com Carl Hymans Investor Relations G.S. Schwartz & Co. 212.725.4500 carlh@schwartz.com
The Quigley Corporation
CONTACT: Media, Karen Pineman, +1-212-725-4500, kpineman@schwartz.com, orInvestor Relations, Carl Hymans, +1-212-725-4500, carlh@schwartz.com, bothof G.S. Schwartz & Co., for The Quigley Corporation
Web site: http://www.quigleyco.com/
