DOYLESTOWN, Pa., Sept. 26 /PRNewswire-FirstCall/ -- Quigley Pharma, a wholly-owned subsidiary of The Quigley Corporation (Nasdaq: QGLY - News) announced today that the results from its human study, titled “Single Center, Dose Escalating, Safety, Tolerability, And Pharmacokinetics Study Of QR-333 In Subjects With Diabetic Peripheral Neuropathy,” demonstrated that QR-333 can be administered safely to patients suffering from diabetic peripheral neuropathy and it will proceed to conducting Phase IIb clinical trials.
The pharmacokinetics trial was the first study in the US conducted under the FDA issued IND. The positive data showed that QR-333 is safe, it is not systemically absorbed and it is well tolerated after multiple doses. These findings are consistent with prior animal toxicity data and the human proof of concept study performed in France.
“Demonstrating that QR-333 can be administered to larger clinical trial populations of patients suffering from the debilitating effects of peripheral diabetic neuropathy is a significant milestone,” added Dr. Richard Rosenbloom, COO, Quigley Pharma. “This gives us great confidence in moving forward quickly on our next Phase IIb study which will evaluate the efficacy of QR-333.”
Based on this positive patient experience, the Company has already manufactured the first large commercial scale-up quantity of the QR-333 compound. Post manufacturing monitoring of the physical and analytical characteristics of the drug product will insure its quality. This essential CMC (Chemistry Manufacturing and Controls) stage will provide the company with the necessary information needed to produce larger quantities of drug for the Phase IIb trial which will involve close to 200 patients.
Quigley will begin the Phase IIb trial once the required positive CMC information is available. The study will take place at some of the nations top diabetic neuropathy research centers. In preparation for the trial, the company has already received initial IRB approval and has begun discussing patient recruitment and screening procedures with the approximately 20-25 trial centers.
About QR-333:
Concentrated and standardized nutrient based active compounds dosed in a topical cream designed to reduce oxidative stress, inflammation and treat symptoms of Diabetic Peripheral Neuropathy, a nerve disorder that can lead to numbness, skin ulcers, constant pain or extreme sensitivity to a stimulus.
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 (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® 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® 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.com carlh@schwartz.com
Source: The Quigley Corporation
