Enamelon Toothpaste Study Indicates Superiority to a Leading Fluoride Toothpaste for Root Caries - Cavities - Prevention in High Risk Patients.
Enamelon, Inc. (Nasdaq NM: ENML), which is using its proprietary "remineralization" technology to develop over-the-counter oral products to help stop cavities before they begin, today announced that recently published interim results of a Tufts University clinical study show Enamelon(R) Anticavity Fluoride Toothpaste to be significantly superior to a leading fluoride toothpaste in the prevention of root caries (cavities) in a high-risk radiation therapy population.
To date, patients using Enamelon(R) Toothpaste in the double-blind, clinical trial showed an average monthly net increase of only 0.06 root-surface caries, versus 0.45 for those using conventional fluoride toothpaste. This means, over a 12 month period, those using a conventional toothpaste would be expected to develop about 5 root surface carious sites, whereas those using Enamelon(R), for the same period of time, would be expected to develop fewer than one root surface carious site. The authors note that the incidence of caries in Enamelon users who have completed 12 months in the study were comparable to results from earlier studies of patients who used daily prescription stannous fluoride mouth trays, a current standard of care for high-risk patients. Unlike the prescription trays, Enamelon is an over-the-counter toothpaste available nationally in leading food, drug and mass merchandise stores.
Dr. Steven R. Fox, CEO and founder of Enamelon stated, "We believe this clinical study is proof that Enamelon's active remineralization technology is a significant breakthrough in caries prevention."
Patients in the study had all completed a specified program of radiation therapy for head and neck cancer, resulting in a reduction or cessation of unstimulated salivary flow. Diminished salivary flow typically results in increased bacteria in the mouth and less available buffer to neutralize acids, both of which lead to increased demineralization (dissolving) of tooth enamel. Additionally, the amount of available calcium and phosphate ions is reduced, resulting in decreased remineralization. Consequently, these patients are at a higher risk for the development of cavities than the general population.
Enamelon(R) All Family Toothpaste and Enamelon Calcium Whitening(TM) System Toothpaste are formulated to enhance remineralization of enamel to prevent caries. Enamelon's patented Liquid Calcium(TM) Formula delivers fluoride along with soluble calcium and phosphate, the building blocks of enamel. Earlier laboratory and human studies have shown Enamelon Toothpaste to be beneficial in the reduction of white spot lesions, and the repair and remineralization of tooth enamel compromised by acidic beverages. In the Tufts study, the authors also noted that a large number of incipient lesions became remineralized during the study.
The interim results of this ongoing study were published in the July edition of Gerodontology, an international peer-reviewed journal. The study is expected to be completed in mid-2000. Enamelon, Inc. is focused on developing and marketing over-the-counter oral products based on proprietary formulations and technologies. The Company's remineralization technologies are designed to provide the active ingredient fluoride in a formulation containing soluble calcium and phosphate to advance the fight against tooth decay. The Company's offices are located in Cranbury, New Jersey.
This release contains forward-looking information and therefore it necessarily involves risks and uncertainties. Factors that could cause actual events to differ materially from these forward-looking statements include, but are not limited to, the following: acceptance of the Company's products by consumers; the inherent limitations of market research and accuracy of syndicated data purchased by the Company; declines in the Company's sales from current levels; the success of the Company's revised marketing program; the Company's ability to produce additional financing, as necessary to maintain its operations until it becomes profitable; and changes in government regulations as they apply to the company's products. These and other risks are described in the Company's filings with the Securities and Exchange Commission, including the Company's Form S-1 and Form S-3 registration statements, Annual Report on form 10-KSB for the year ended December 31, 1998, and 1999 Quarterly Reports on Form 10-Q.
Note: Further information on Enamelon is available through our website on the World Wide Web at http://www.enamelon.com.
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|Date:||Aug 26, 1999|
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