Sunday, June 04, 2006 1:16:59 AM
Quigley Initiates Development Plan to Test QR-441(A) Against Avian Flu in Poultry Stocks Company Enlists Industry Experts to Assist in the Design of INAD (Investigational New Animal Drug) Bird Challenge Studies
Tuesday March 21, 7:00 am ET
DOYLESTOWN, Pa., March 21 /PRNewswire-FirstCall/ -- Quigley Pharma, a wholly-owned subsidiary of The Quigley Corporation (Nasdaq: QGLY - News), announced today that it is planning a series of controlled experiments designed to test its all natural broad spectrum antiviral compound QR-441 (a) against H5N1 (avian flu) in poultry stocks., The company is also pleased to announce that Dr. Timothy S. Cummings, MS, DVM, ACPV Clinical Poultry Professor at the College of veterinary medicine at Mississippi State University and Thomas G. Voss, Ph.D. Assistant Professor Tulane University school of medicine will be assisting Quigley in the development of the INAD bird challenge studies.
"We are very happy to have two distinguished experts in Dr. Cummings and Dr. Voss involved with the protocol development process," said Dr. Richard Rosenbloom, COO and Executive Vice President. "Their expertise developing poultry veterinary trials will help us to design the most appropriate studies possible."
The announcement follows a lengthy nationwide search for thought leaders in poultry and veterinary science. After negotiations with several potential researchers, the company received commitments from Drs. Voss and Cummings.
The company plans to complete several studies starting with phase I healthy chicken safety studies to be followed by challenge studies in H5N1 infected birds. While the timeline for these studies has not been determined, the company would like to have their studies completed prior to any potential threat to the US Poultry Population.
According to previously announced in vitro testing, QR-441A appears to have the potential to inhibit infectivity of the avian H5N1 virus in poultry populations. The FDA will be consulted under these INADs regarding company generated protocols in order to expedite these studies and the steps that will be required in order to get QR-441A approved as a veterinary drug. An INAD is the equivalent to an IND (Investigational New Drug) for the human ethical drug approval process. The QR-441 avian flu studies in chickens marks the first effort of the Veterinary Division of Quigley Pharma, which will be followed by a canine arthritis development plan for QR-440, a naturally derived broad spectrum anti-inflammatory compound.
About Thomas Gregory Voss, Ph.D.
As Vice President and Chief Scientist of Homeland Security and Infectious Disease Research Division, Southern Research Institute Birmingham between 2002 and 2004, Voss was responsible for biodefense and emerging infectious disease drug and vaccine discovery and development. He developed in vitro antiviral and in vivo animal models program for SARS-CoV infection and small animal models of infection for antimicrobial and vaccine evaluation. He was also responsible for therapeutic and vaccine evaluation using Good Laboratory Practices (GLP) and FDA required data collection and management procedures for new drug or vaccine application.
Membership in Academic and Professional Societies:
American Society for Microbiology, National Member
American Society for Microbiology, Texas Branch Member
American Society for Microbiology, South Central Branch Member
University of Texas-Arlington, Microbiology Society (Student
Organization), Co-founder and President (1989)
About Timothy S. Cummings, MS, DVM, ACPV
As a part of the poultry industry for over 20 years, Professor Cummings has experience in the live production and technical services side of the poultry industry. He teaches poultry diseases and coordinates and oversees the Dual Degree Program for veterinary students. His research has been focused on spray and water vaccination techniques, antimicrobial resistance and lighting effects in poultry.
2001 to present - Clinical Poultry Professor at Mississippi State
University's CVM
1992 thru 2000 - Senior Technical Services Veterinarian for Pfizer Animal
Health
Professional Associations Include:
Diplomate of the American College of Poultry Veterinarians
American Association of Avian Pathologists
American Veterinary Medical Association
AAAP Drugs & Therapeutic Committee, Chair
AVMA Steering Committee on Antimicrobial Resistance
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.
The Quigley Corporation makes no representation that the U.S. Food and Drug Administration or any other regulatory agency will grant an IND for human study or take any other action to allow the aforementioned compound 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.
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
http://biz.yahoo.com/prnews/060321/nytu028.html?.v=45&printer=1
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