DOYLESTOWN, Pa., May 14 /PRNewswire-FirstCall/ -- The Quigley Corporation (Nasdaq: QGLY) announced positive results from a study conducted by its wholly owned subsidiary, Quigley Pharma Inc., which was conducted in chickens to evaluate the anti-viral activity of its compound QR448(a). The compound was administered to chicks that had been infected with Infectious Bronchitis Virus (IBV). The data from the study indicated that QR448(a) is efficacious against an IBV challenge in two week old specific pathogen free (SPF) chicks, confirming previous results indicating that treatment with QR448(a) before or after viral exposure has the potential to lessen or prevent disease.
Preventing and treating infectious bronchitis caused by IBV is a worldwide concern of the poultry industry which calculates its loses due to this disease in lowered weight gains and feed efficiency in broilers, lowered production and quality of eggs in layers and breeders, mortality, clean-up costs and disruption to operations.
The Company initiated its investigations into the effectiveness of this compound based on feedback from poultry industry leaders who expressed an increasing need for additional products to combat Infectious Bronchitis (IBV).
Dr Richard Rosenbloom, Executive Vice President and Chief Operating Officer of Quigley Pharma stated: "With the increased emphasis by the animal health community on prevention as well as treatment of disease, the results from our experiments in chickens have demonstrated that our QR448(a) compound can prevent as well as treat 2 week old SPF chicks from infection when challenged with IBV in a dose response experimental design. We believe this innovative, non-vaccine, broad spectrum antiviral has the potential to offer the poultry industry a natural base solution to this growing problem."
With the completion of this latest study and the current dossier of data the company plans to solicit the poultry industry for additional guidance and potential interest and opportunities for developing this compound jointly toward commercialization.
About the study:
This study was conducted by Dr. Mark Jackwood Professor, Department of
Population Health, College of Veterinary Medicine, University of Georgia
who concluded that based on the results:
-- A 1:20 dilution of QR448(a) given to two week old chickens by aerosol
treatment at a dose of 1ml per bird 2 hours before challenge was
effective in significantly lowering the amount of challenge virus in
the trachea to undetectable levels (less than or equal to 100 EID [for
50%], p less than or equal to 0.2).
-- Aerosol treatment of QR448(a) 2 hours after challenge was effective at
lowering the amount of virus in the trachea to approximately 1 X 10 (to
the 2.5 power) EID (for 50%) (p less than or equal to 0.2), which is
significant, as disease is typically not observed when less than 1 X
10 (to the 3 power) EID (for 50%) is used for challenge.
-- Effective dosing was established between high and low concentrations of
QR448(a). Higher concentrations may have created an environment in the
upper-respiratory tract allowing virus infection to occur. In
addition, the lowest concentrations of QR448(a) appear to be
insufficient for preventing virus infection. The optimum dose was
established in this trial to be 1:20 dilution for success.
Dr. Jackwood stated: "The reduction of clinical signs and detection of fewer virus particles in chickens challenged with an extremely infectious and virulent strain of IBV was quite remarkable. There are many different types of IBV but generally one type of IBV vaccine only protects against the same virus type. The ability to mass deliver this all-natural compound ought to mesh well with a control program for IBV regardless of the type of the virus."
A chronological summary of the data from studies conducted to date on
-- The formulation was initially identified as QR441(a) and for its
anti-viral activity against Highly Pathogenic Avian Influenza H5N1.
-- In-vitro anti-viral activity was shown against IBV at maximum effective
non-toxic concentrations of QR448(a).
-- In embryonating eggs, non-toxic concentrations were shown to cause
100fold reductions in IBV titer with no noticeable adverse effects on
embryo developing chicks.
-- The best route of administration of QR448(a) to challenged 2 week old
SPF chicks was by aerosol spray as opposed to direct intranasal or
addition to drinking water.
-- Aerosol spray treatment of 2 week old SPF chickens with QR448(a) 6 or 2
hours before or 2 hours after challenge with IBV abrogates the course
of the disease by lowering the presence of virus in the trachea to
undetectable levels and reducing the severity of lesions in the
-- A clear and safe dose response has been determined that provides a
significant log reduction in viral titer in the trachea of 2 week old
SPF chickens treated with QR448(a) 2 hours before or 2 hours after
challenge with IBV.
The Quigley Corporation makes no representation that the U.S. Food and Drug Administration or any other regulatory agency will issue an investigational new animal drug number or allow this compound to be marketed for IBV. 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 (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(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 wholly owned subsidiaries; Quigley Manufacturing Inc. consists of two FDA approved facilities to manufacture COLD- EEZE(R) lozenges as well as fulfill other contract manufacturing opportunities and Quigley Pharma Inc. (http://www.QuigleyPharma.com) conducts research in order to develop and commercialize a pipeline of patented botanical and naturally derived potential 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.
|SOURCE The Quigley Corporation|
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