DOYLESTOWN, Pa., June 20, 2007 /PRNewswire-FirstCall/ -- Quigley Pharma, www.QuigleyPharma.com, a wholly owned subsidiary of The Quigley Corporation announced today that it has completed a follow-up study to evaluate the impact of QR-443 on levels of a pro-inflammatory cytokine Interleukin-6 (IL-6) in a cachexia model. This new data concluded that responding mice had lower levels of serum IL-6 when administered QR-443 orally than mice that received placebo. This reduction in IL-6 suggests a method of action for the delayed onset and reduced severity of cachexia observed in this study as well as the previously conducted cachexia model study.
QR-443 was formulated with the intention to impact metabolic imbalances and chronic inflammation. Cachexia is an extremely debilitating and life threatening, wasting syndrome associated with chronic diseases such as cancer, AIDS, chronic renal failure, COPD and rheumatoid arthritis, where inflammation has a significant impact and patients experience loss of weight, muscle atrophy, fatigue, weakness and decreased appetite.
A reduction in IL-6 is associated with a reduction in inflammation and suggests that QR-443 may have a role in a broad range of chronic inflammatory diseases. The Company has begun developing a human study protocol to evaluate the safety and impact of this compound on specific metabolic processes altered by chronic inflammation and the presence of IL-6.
Chronic inflammation is also associated with other disorders such as rheumatoid arthritis, metabolic syndrome, COPD, AIDS and cancer and can cause physical, metabolic and physiological limitations. Interleukin-6 (IL-6) is a pro-inflammatory cytokine secreted to stimulate an immune response to trauma and disease leading to inflammation. Inflammation and the presence of IL-6 have been shown to negatively effect "normal" metabolic processes and pathways - a disruption of homeostasis.
Dr. Richard Rosenbloom EVP/COO Quigley Pharma, Inc. stated, "We are encouraged by these and previous results and are looking forward to subjecting the compound to more rigorous tests to support eventual commercialization."
About The Study
The study results demonstrated a correlation to the levels of serum IL-6 and the degree of cachexia. Mice responding to QR-443 treatment had much lower levels of serum IL-6 which correlated with reduced cachexia, compared to non responders and the control population who had elevated IL-6 and dramatic weight loss. These findings are in agreement with several previous studies demonstrating the increased presence of IL-6 in the etiology of cachexia and other diseases related to inflammation.
The purpose of the study was to replicate positive oral dose response trials in BALB/C mice as well as to investigate the possible relationship of the levels of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-alpha) and interferon gamma (IFN-gamma) cytokines which have been associated with the severity and progression of cachexia. In this experiment a larger group of mice was used, their weight being recorded and blood being drawn prior to the onset of cachexia and then at the peak of cachexia which marked the end of the experiment. There was no correlation between the levels of TNF-alpha and the severity of cachexia and levels of IFN-gamma were lower than the detectable assay level.
The Quigley Corporation makes no representation that the U.S. Food and Drug Administration or any other regulatory agency will allow the aforementioned Compound to be tested in humans or 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 Reme dy 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 four (4) 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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