DOYLESTOWN, Penn., Oct. 3 /PRNewswire-FirstCall/ -- Quigley Pharma, a wholly-owned subsidiary of The Quigley Corporation announced that it has received significant data identifying 50 microliters as the least toxic and most effective radiation protection dose in mice when administered ip (intraperitoneal), po (by mouth) or sc (under the skin) prior to radiation exposure. These experiments were essential for providing the company with data to optimize the formulation for efficacy and route of administration, which is required for filing under the FDA "Animal Efficacy Rule".
In the study, conducted by Dr. William McBride of UCLA, C3H/Sed//Kam mice were treated with doses of the compound determined to be the least toxic, highest tolerated dose. A 50microliter dose was administered to C3H mice ip, po and sc for 5 days before exposing the mice to 8 Gy whole body irradiation using a 137-cesium source. The standard for efficacy is post radiation treatment survival of 30 days. In general 50%-100% of the mice in various groups treated with QR336 were healthy after 30 days. Notably, 40-50% of the mice treated with QR336 were healthy at 35 days with 12.5% of one group being so at 112 days. Conversely and in comparison, all of the non-treated mice became terminally ill within 21 days of radiation exposure.
Commenting on the data, Quigley Pharma's, Chief Operating Officer, Dr. Richard Rosenbloom, said: "These experiments continue to demonstrate that this compound has protective capabilities and this data has helped us better understand the pharmacokinetics and toxicity of the compound. These experiments will assist us in refining the formulation so that our continuing investigations can focus on critical questions such as, synergism of ingredients, optimum route of administration, dose modifying factor and post irradiation treatment all of which the FDA will require for filing an IND."
The Company is currently reviewing protocols with Dr. McBride for the next series of studies which will investigate the individual components of the drug and explore mechanisms of action.
About QR336:
Standardized concentrated nutrient/phytochemical based compound that has been shown in several pre-clinical mouse model studies to decrease the systemic effects of ionizing radiation. This strongly suggests the capability to provide a degree of protection against radiation damage making the compound potentially useful to, healthcare workers such as interventional cardiac surgeons working with fluoroscopic instrumentation, University and industry researchers as well as nuclear industry workers that may be at risk of exposure.
The Quigley Corporation makes no representation that the US Food and Drug Administration or any other regulatory agency will allow this Investigational New Drug to be marketed. Furthermore, no claim is made that potential medicine discussed herein is safe, effective, or approved by the Food and Drug Administration. Additionally, data that demonstrates activity or effectiveness in animals or in vitro tests do not necessarily mean the formula test compound; referenced herein will be effective in humans. Safety and effectiveness in humans will have to be demonstrated by means of adequate and well-controlled clinical studies before the clinical significance of the formula test compound is known. Readers should carefully review the risk factors described in filings the Company files from time to time with the Securities and Exchange Commission.
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.,for Quigley Pharma, +1-212-725-4500
Web site: http://www.quigleyco.com/
