Professor Paul Valensi to Present Research on Quigley's QR-333 at the Diabetes 2004 Conference in Nice, France.Business Editors/Health/Medical Writers Diabetes 2004 Conference DOYLESTOWN, Pa.--(BUSINESS WIRE)--March 3, 2004 The Quigley Corporation (Nasdaq:QGLY) today announced that the results of its "Phase II Proof of Concept Study For The Treatment of Diabetic Peripheral Neuropathy Diabetic peripheral neuropathy A condition where the sensitivity of nerves to pain, temperature, and pressure is dulled, particularly in the legs and feet. Mentioned in: Diabetes Mellitus With Topical QR-333: A Multi-Center, Double Blind, Placebo-Controlled Study," has been accepted for presentation at the Diabetes 2004 Conference, March 23-27, 2004, in Nice, France. The study concluded that subjects taking QR-333 had 67% of their symptoms improve, strongly suggesting efficacy. The Diabetes 2004 Conference is an annual symposium sponsored by ALFEDIAM ALFEDIAM Association de langue française pour l'étude du diabète et des maladies métaboliques ALFEDIAM Association de Langue Francaise pour l'Etude du Diabete et des Maladies Metaboliques (French) , the Association for French Language Studies of Diabetes and Metabolic Illnesses. ALFEDIAM is an equivalent of the American Diabetes Association The American Diabetes Association, or the ADA, is an American health organization providing diabetes research, information and advocacy. Founded in 1940, the American Diabetes Association conducts programs in all 50 states and the District of Columbia, reaching hundreds of in France. TRIAL DESIGN The study used a total of 30 patients who were randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. into a double-blind, placebo-controlled trial. It was a multi-center trial performed in France under the direction of the Principal Investigator, Professor Paul Valensi, M.D., Hospital Jean Verdier, Service d'Endocrinologie, Avenue du 14 Juillet 93143 Bondy Cedex, France. Efficacy was evaluated by use of the following instruments of evaluation: -- Quality of Life questionnaire completed at: baseline, 2 weeks of treatment, 4 weeks of treatment, and 2 weeks post treatment. -- Symptom Assessment completed at: baseline, 1 week of treatment, 2 weeks of treatment, 4 weeks of treatment, and 2 weeks post treatment. TRIAL RESULTS Quality of Life: After four weeks of treatment, the active group substantially outperformed the placebo group in thirteen out of fourteen Quality of Life parameters. Symptom Assessment: Out of a total of 28 Symptom Assessment parameters, patients receiving the active formula fared substantially better than those on placebo. Certain key symptoms showed a substantially wider improvement ratio, suggesting that the active formula was particularly effective for the following symptoms: -- Irritation of the feet due to socks or sheets. -- Numbness of the feet -- Tingling tin·gle v. tin·gled, tin·gling, tin·gles v.intr. 1. To have a prickling, stinging sensation, as from cold, a sharp slap, or excitement: tingled all over with joy. of the feet. Diabetes afflicts 15.7 million people in the United States, according to data compiled from 1995-1998 by the National Institute of Diabetes and Digestive and Kidney Diseases About NIDDK The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), of the U.S. National Institutes of Health, conducts and supports research on many of the most serious diseases affecting public health. (NIDDK NIDDK National Institute of Diabetes and Digestive and Kidney Diseases ). According to the NIDDK, the data also found that 60 to 70 percent of diabetics suffer mild to severe forms of nervous system damage and resultant pain, a condition known as diabetic peripheral neuropathy. The Quigley Corporation (Nasdaq:QGLY), www.Quigleyco.com, is a leading developer and marketer of diversified health products including the Cold-Eeze(R) family of patented zinc gluconate glycine glycine (glī`sēn), organic compound, one of the 20 amino acids commonly found in animal proteins. Glycine is the only one of these amino acids that is not optically active, i.e. (ZIGG(TM)) lozenges and sugar free tablets. Cold-Eeze is the only (ZIGG(TM)) lozenge lozenge /loz·enge/ (loz´enj) [Fr.] 1. troche; a discoid-shaped, solid, medicinal preparation for solution in the mouth, consisting of an active ingredient incorporated in a suitably flavored base. 2. 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 OTC See: Over-the-counter. OTC See over-the-counter market (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. The Quigley Corporation makes no representation that the U.S. Food and Drug Administration or any other regulatory agency regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. will grant an IND or take any other action to allow the aforementioned products 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. Additionally, data that demonstrates activity or effectiveness in animals or in vitro tests do not necessarily mean that 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. Certain statements in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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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