Quigley Pharma Inc. Begins Human Trial to Investigate Effects of Broad Spectrum Anti-Inflammatory Compound on Metabolic Syndrome Patients
DOYLESTOWN, Pa., July 30 /PRNewswire-FirstCall/ -- Quigley Pharma, www.QuigleyPharma.com, a wholly owned subsidiary of The Quigley Corporation announced today that based on positive preclinical animal data and Institutional Review Board (IRB) approval it has initiated a human clinical safety trial designed to evaluate the effects of QR-449 on subjects with Metabolic Syndrome. People suffering from Metabolic Syndrome are vulnerable to the most dangerous heart attack risk factors; diabetes, abdominal obesity, high cholesterol and high blood pressure.
The primary objectives for the study are; the determination of safety and to measure the corrective capacity of the compound on the imbalance of important anti-oxidant, nutrient and pro-inflammatory markers as well as other metabolic disturbances, associated with Metabolic Syndrome. Laboratory bio- markers will function to monitor safety as well as efficacy.
The International Disease Foundation has estimated that one quarter of the worlds population have metabolic syndrome (also know as syndrome X). As many as 65 million Americans are effected and the condition is also afflicting an increasing number of children and adolescents as the worldwide epidemic of obesity spreads across all age groups.
QR-449 has been formulated to aid the body in returning to homeostasis, through the modification of levels of pro-inflammatory cytokines and other factors. The Quigley compound has already been shown in previous studies to specifically reduce levels of the pro-inflammatory cytokine Interleukin-6 (IL- 6) whose presence has been linked to a disruption of homeostasis. Chronic inflammation is frequently associated with Metabolic Syndrome. Inflammatory markers that have been associated with Metabolic Syndrome include CRP, TNF-Alpha, fibrinogen, and IL-6, among others.
This patient study is being conducted at The Diabetes and Glandular Research Center of San Antonio, Texas, under the supervision of Lead Investigator, Dr. Sherwyn L. Schwartz.
Dr. Schwartz stated; "Affecting one in four American adults, Metabolic Syndrome, is fast becoming a significant health problem. Inflammation plays a major role in this and several other disorders such as Rheumatoid Arthritis, Cancer and Cachexia. The prospect of having a safe, non-toxic therapy to address these problems would be significant."
Dr. Richard Rosenbloom, Executive VP COO Quigley Pharma, added; "The aim of this protocol, a first in human study, is to better characterize the safety and pharmacologic action of the formulation."
About the Study:
This is an open label, dose ranging study to evaluate the effects of QR- 449 on subjects with Metabolic Syndrome. The study will be conducted at a single sight on fifteen evaluable subjects who have met the diagnosis criteria for Metabolic Syndrome as described by the WHO. Each randomized patient will receive treatment for eight weeks with their blood, urine and physical conditions monitored regularly.
The primary objectives for the study are: -- Determine the safety of QR-449 when administered in a dose ranging fashion -- Determine the effect of QR-449 on metabolic imbalances as determined through blood and urine laboratory markers in a dose ranging fashion.
About Metabolic Syndrome:
As defined by the IDF (International Diabetes Foundation); The Metabolic Syndrome (MetSyn) is a cluster of the most dangerous heart attack risk factors: diabetes and pre-diabetes, abdominal obesity, high cholesterol and high blood pressure. Although the underlying cause of MS is not completely understood, experts believe that insulin resistance, central obesity, genetics, physical inactivity, pro-inflammatory state and hormonal changes as well as ethnicity are believed to be contributing and complicating factors.
The Quigley Corporation makes no representation that if this product is a prescription drug or medical food the US Food and Drug Administration or any other regulatory agency will allow this product to be marketed. Furthermore, no claim is made that potential medicine discussed herein 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.
Forward-Looking Statements
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.comcarlh@schwartz.com
Quigley PharmaCONTACT: Media, Karen Pineman, kpineman@schwartz.com, or InvestorRelations, Carl Hymans, carlh@schwartz.com, both of G.S. Schwartz & Co,+1-212-725-4500, for Quigley Pharma