DOYLESTOWN, Pa., June 23 /PRNewswire/ -- The Quigley Corporation said today that it intends to repeat a low-dosage zinc gluconate glycine study originally conducted at the Cleveland Clinic Foundation. The Company feels that the study to be published in the Journal of the American Medical Association (JAMA) on June 24 did not follow the research agreement or the protocol agreed to by The Quigley Corporation and the Cleveland Clinic Foundation. There were 129 protocol deviations involving at least 83 out of the 249 patients enrolled in that study, which can only be considered bad science. "The purpose of the study was to identify whether a lower dosage would be effective," said Company Chairman Guy J. Quigley. "The protocol violations are so significant that no conclusion as to the effectiveness of zinc gluconate glycine in a lower dosage in treating children can be determined. Therefore, we intend to repeat the low-dosage study test at another medical facility," he added. The need to undertake a new study on a low-dosage zinc gluconate glycine formulation is necessary because of the flaws in the Cleveland Clinic Foundation children's study. The Quigley Corporation will not know whether a lower dosage of zinc gluconate glycine will be effective until that study is completed. The original Cleveland Clinic Foundation study published in July of 1996 in the Annals of Internal Medicine relates to the 13.3 mg. zinc gluconate glycine lozenge manufactured by The Quigley Corporation under the trade name COLD-EEZE(R). This study showed that treatment with COLD-EEZE(R) resulted in a 42% reduction in the duration and severity of the common cold symptoms. COLD-EEZE(R) is widely and successfully used by children and adolescents on a daily basis. The low-dosage (10 mg. zinc gluconate glycine formulation) study to be published in JAMA was performed by the Cleveland Clinic Foundation under Dr. Michael L. Macknin. The study states that the lower-dosage zinc gluconate glycine lozenge was not effective in treating common cold symptoms in children and adolescents. 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 results, 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. The Quigley Corporation is the maker of COLD-EEZE(R), the only zinc gluconate glycine (ZIGG(TM)) lozenge proven in two double blind studies to reduce the duration and severity of the common cold symptoms. For detailed information on the 129 protocol deviations, contact Karen Goldman of INFOCUS, Inc. at 609-683-9055 x106.
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