Quigley Pharma Inc. To Commence Human Testing Of Its QR-333 Topical Diabetic Peripheral Neuropathy Investigational New Drug; FDA Finalizes Review Cycle And Gives Quigley Pharma Inc. Go Ahead To Begin Phase II Studies Under IND Number 67,168
DOYLESTOWN, Pa., April 10 /PRNewswire-FirstCall/ -- Quigley Pharma, a wholly owned subsidiary of The Quigley Corporation , announced today that it will be commencing human studies on its investigational new drug, QR-333. Patient screening and enrollment will begin immediately for the first of two human trials designed to determine the safety pharmacokinetics of Quigley's Investigational New Drug, QR-333. A Phase II(b) Dose ranging study will commence after the completion of the pharmacokinetic study.
The Company also announced that in anticipation of receiving this IND, it has previously held its investigators meeting to organize its multi-center phase 2(b) trials. This will allow Quigley to begin these trials as soon as study drug is available.
"We are anxious to start clinical trials for QR-333 within the FDA IND program," said Dr. Richard Rosenbloom, COO and Executive Vice President of Quigley Pharma. "The granting of this IND number is a significant milestone for this company and the result of a significant coordinated effort."
The original proof of concept study, completed in France, showed that the topical compound improved the quality of life as well as improved key symptoms associated with this complication of diabetes. The subjects using the compound had 67% of their symptoms improve, suggesting efficacy. QR-333 has since been evaluated in animal model toxicity experiments previous to the FDA granting this IND.
The Quigley Corporation makes no representation that the U.S. Food and Drug Administration or any other regulatory agency will allow the aforementioned Investigational New Drug to be marketed. Furthermore, no claim is made that the potential medicine discussed here is safe, effective, or approved by the Food and Drug Administration.
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 four (4) 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.
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.
All media inquiries for Quigley Pharma should be directed to: 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 CorporationCONTACT: Media: Karen Pineman, kpineman@schwartz.com; Investor Relations:Carl Hymans, carlh@schwartz.com, both of G.S. Schwartz & Co., for TheQuigley Corporation, +1-212-725-4500