DOYLESTOWN, Pa., May 9 /PRNewswire-FirstCall/ -- Quigley Pharma, a wholly-owned subsidiary of The Quigley Corporation , announced today that it has begun screening patients to start testing their investigational new drug QR-333. Starting May 15th, patients suffering from diabetic peripheral neuropathy will be given doses in an escalating fashion to provide pharmacokinetics data.
This study is being conducted at The Diabetes & Glandular Disease Research Center in San Antonio, under the supervision of Dr. Sherwyn Schwartz. The FDA has reviewed this protocol, as well as the Institutional Review Board assigned to the protocol under the QR-333 IND program. QR-333 has been evaluated in animal model pharmacokinetic experiments prior to the FDA granting the IND.
“We are excited to start the clinical trials for QR-333 in San Antonio,” said Dr. Richard Rosenbloom, COO and Executive Vice President of Quigley Pharma. “We couldn’t be more pleased to be working with such a distinguished investigator as Dr. Schwartz throughout the beginning stages of these trials.”
The original proof of concept study, completed in France, showed that study subjects improved quality of life measures as well as improved key symptoms associated with this complication of diabetes. The subjects tested had 67% of their symptoms improve, suggesting efficacy.
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 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.
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. forThe Quigley Corporation, +1-212-725-4500
