DOYLESTOWN, PA. - November 6, 2003 - The Quigley Corporation (Nasdaq: QGLY)
today announced that an independent study by Retroscreen Virology Ltd, found
that intranasal application by spray of Quigley Pharma's QR-435 was 100 percent
effective in preventing non-infected ferrets in close proximity to an infected
ferret from becoming infected with the influenza A virus (the "prophylaxis
experiment"). The study also found that intranasal application by spray of
QR-435 could prevent an infected animal, when treated, from transmitting the
influenza A virus to other animals in close proximity (the "transmission
experiment"). The ferret is an established animal model for the study of
influenza infection. On the strength of these data, Quigley intends to initiate
a Phase II proof of concept human trial in Europe.
The study examined a total of 50 ferrets. The study determined that the QR-435
test compound was 100 percent effective at preventing infection in the
recipient animals in the prophylaxis experiment, and was partially effective in
the transmission experiment.
In the prophylaxis experiment, a fourfold rise in antibodies against the
influenza A virus, or seroconversion, was used to determine Influenza
infection. The recipient animals receiving QR-435 outperformed a leading
prescription Influenza drug (comparison drug) and the placebo treatment groups.
100 percent of animals in both the (comparison drug) treatment group (eight of
eight) and placebo treatment group (two of two) seroconverted. By contrast,
none of the animals (zero of eight) in the QR- 435 treatment group
seroconverted.
In the transmission experiment, 100 percent of animals in both the placebo
treatment group (four of four) and the (Comparison Drug) treatment group (eight
of eight) seroconverted. By comparison, only 57 percent (four of seven) of
those animals tested in the QR-435 treatment group seroconverted.
Seroconversion was defined as a four-fold rise in antibodies against the
influenza A virus.
Dr. Richard Rosenbloom, Executive Vice President and Chief Operations Officer
of Quigley Pharma Inc., stated, "These results are exciting and provide ample
encouragement to proceed to the next level of development with a goal of
prescription drug approval."
Retroscreen Virology Ltd, an independent research virology company affiliated
with the University of London, conducted the study. Professor John S. Oxford,
the firm's senior scientist, is Professor of Virology at St. Bartholomew's and
The Royal London School of Medicine and Dentistry at the University of London.
He is the co-author of two standard texts on influenza and virology, and has
published 250 scientific papers throughout the world.
Retroscreen specializes in developing anti-viral compounds and vaccines, and
has worked with many pharmaceutical companies to assist them in developing
products that now help to fight viral disease worldwide. Additional information
is available on the company's website at www.retroscreen.com.
The Quigley Corporation makes no representation that the U.S. Food and Drug
Administration or any other regulatory agency will grant an IND or take any
other action to allow the QR formulation to be studied or marketed.
Furthermore, no claim is made that the potential medicine discussed here is
safe, effective, or approved by the Food and Drug Administration.
The Quigley Corporation (Nasdaq: QGLY, http://www.Quigleyco.com) is a leading
developer and marketer of diversified health products including the Cold-Eeze®
family of patented zinc gluconate glycine (ZIGGTM) lozenges and sugar free
tablets. Cold-Eeze is the only (ZIGGTM) lozenge proven in two double-blind
studies to reduce the duration of the common cold from 7.6 to 4.4 days or by
42%. In addition to Over-The-Counter (OTC) products, the company has formed
Quigley Pharma Inc. (http://www.QuigleyPharma.com ), a wholly owned ethical
pharmaceutical subsidiary, to introduce a line of naturally-derived patented
prescription drugs. The Quigley Corporation's customers include leading
national wholesalers and distributors, as well as independent and chain food,
drug and mass merchandise stores and pharmacies.
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.