DOYLESTOWN, Pa. July 19 /PRNewswire-FirstCall/ -- Quigley Pharma, a wholly-owned subsidiary of The Quigley Corporation , announced today that it has obtained positive results that support Quigley Pharma's continued progress in developing the natural broad spectrum anti-viral QR-441(a) for use in preventing the spread of avian flu in poultry stocks. The results of the healthy chicken medical feed study confirm that food or water dose forms provide an opportunity for potential commercialization if the compound demonstrates efficacy within these dose forms.
The results clearly showed that the chickens tolerated and consumed all concentrations of QR-441(a) in the medicated feed. They also tolerated and consumed the low concentration of drug in the medicated water. Dr. Timothy Cummings, MS DVM, ACPV, Clinical Poultry Professor, College of Veterinary Medicine, Mississippi State University conducted the trial.
The Company is preparing to test QR-441(a) in chickens infected with H5N1 in challenge studies. These studies will center on the well-tolerated medicated food and water although other dose forms or delivery systems may be considered. To that end, the Company has developed challenge study protocols and has entered into preliminary agreements with several international research facilities that are qualified to conduct challenge testing with such highly infective pathogens. These proposed studies are in support of a previously assigned FDA INAD No. 011427 that allows Quigley Pharma to conduct further in-vivo chicken challenge studies.
"Follow up efficacy challenge studies will be conducted internationally for two reasons, primarily due to the fact that there are few domestic facilities willing to conduct chicken challenge studies with this highly infective pathogen, and secondly, to facilitate the broadest possible distribution in the event of positive results and an eventual outbreak," stated Dr. Richard Rosenbloom, COO, Quigley Pharma.
Should an outbreak of H5N1 occur in the United States, the federal and local government, working in conjunction with the poultry industry, will likely establish a hot zone where all poultry will be slaughtered. Immediately outside the hot zone will be a buffer zone perimeter in which poultry will be at a greater risk of infection by H5N1 than those further outside the hot zone. QR-441(a) is designed specifically for use in the buffer zone perimeter.
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.
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