Thursday September 7, 2:50 pm Eastern Time
Press Release
SOURCE: Gum Tech International, Inc.
Zicam(TM) Allergy Relief Pilot Study Published In Peer-Reviewed Online Medical Journal
WOODLAND HILLS, Calif., Sept. 7 /PRNewswire/ -- Gum Tech International, Inc. (Nasdaq: GUMM - news) and Gel Tech, LLC today announced that the online peer-reviewed journal, The Internet Journal of Family Practice, has published the results of a double-blind scientific study on Zicam(TM) Allergy Relief, Gel Tech's over-the-counter homeopathic allergy remedy. According to the pilot study (``Daily Application of the Homeopathic Remedy Zicam(TM) Allergy Relief Significantly Improves the Quality of Life and Impairment in Patients with Seasonal Allergic Rhinitis''), (http://www.ispub.com/journals/IJFP/Vol1N1/zicam.html), the proprietary nasal gel, currently marketed as Zicam(TM) Allergy Relief, reduced the severity of allergic symptoms by 52%, improving the quality of life and impairment in patients with seasonal allergies.
The Internet Journal of Family Practice is an online peer-reviewed journal published by Internet Scientific Publications LLC, whose Web site was selected by the editors of Britannica as one of the best sites on the Internet for quality, accuracy of content, presentation and usability.
``The goal of this pilot study was to test the effectiveness of a new treatment (Zicam(TM) Allergy Relief) for seasonal rhinitis,'' said lead investigator Dr. Sion Nobel, MD, Mission Hills Medical Center. ``In this study, I found that Zicam(TM) was very effective in relieving primary allergic symptoms such as hay fever, nasal and ocular symptoms, experienced by allergy sufferers thereby improving their quality of life. There is an inherent need for safe over-the-counter allergy remedies with a low incidence of side effects; it appears that Zicam(TM) Allergy Relief fills this need.''
``Naturally, we are pleased that an independent pilot study on the effectiveness of our allergy product was accepted for publication by a peer-reviewed journal. This represents another step in substantiating the effectiveness of our products utilizing Zicam(TM)'s unique nasal delivery system. However, the results of the study, while encouraging, are only preliminary. Additional study needs to be done on the product,'' said Brown Russell, Chairman of Gum Tech's Board of Directors. ``We are also delighted that the researcher chose this innovative online venue for publishing his study.''
The Study
The double blind placebo-controlled study was lead by Dr. Sion Noble over a two-week period. Thirty-two outpatients with seasonal allergic rhinitis were enrolled into the study and received either a 0.15ml dosage per application of the proprietary nasal gel containing the active ingredient or a placebo 4 times daily. Efficacy was determined by assessing the improvement in the quality of life as measured by means of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). After the two week trial period, the overall RQLQ scores of the treated patients improved by 52% +/- 7 from the baseline whereas patients receiving the placebo had an overall improvement of 19% +/- 14 (p<.05).
Allergic Rhinitis
According to the National Institute of Health, more than 35 million Americans suffer from seasonal allergic rhinitis, otherwise known as hay fever. Hay fever sufferers alone experience 28 million days of restricted activity, six million days of bed rest, 3.5 million days of work loss, two million lost school days and 8.4 million office visits each year.
An allergy is a strong response by the body's immune system to particles known as allergens. Allergens commonly come from pollen, particular plants, dust particles, and pet dander. Many people are sensitive to one or more allergens. The body's immune system typically responds to the presence of these allergens by causing an allergic reaction, creating symptoms such as runny nose, sneezing, itchy and watery eyes, nasal congestion and sinus pressure.
According to Dr. Sion Noble's research, untreated allergic rhinitis may develop into a chronic state of inflammation and nasal obstruction that can lead to more serious diseases in both the upper and lower airways. It is now recognized that adequate pharmacotherapy for seasonal allergic rhinitis must not only control symptoms but should help patients feel better and function better in their everyday lives.
Zicam(TM)
Zicam(TM) Allergy Relief was developed by Gel Tech, LLC, a joint venture between Gum Tech International, Inc., a publicly held company located in Phoenix, AZ and BioDelivery Technologies, Inc., a privately held biotechnology company. Gel Tech, LLC also developed Zicam(TM) Cold Remedy, a revolutionary homeopathic remedy clinically proven to reduce the duration of the common cold by 71% when taken at the onset of symptoms. Gum Tech and BDT are engaged in the development of unique systems for delivering bioactive compounds.
Zicam(TM) Allergy Relief and Zicam(TM) Cold Remedy are currently available at more than 50,000 drug stores, grocery stores, pharmacies, mass merchants, club stores and convenience stores nationwide. For more information, call 1-877-942-2626 or log onto www.zicam.com.
Gum Tech Forward-Looking Statement:
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expectation that Zicam(TM) Allergy Relief will provide the same benefits to consumers as it did to participants in the study, the anticipated demand for Zicam(TM) Allergy Relief at the retail and consumer level, anticipated favorable customer response for Zicam(TM) Allergy Relief, and the Company's ability to achieve widespread distribution and market acceptance for this new product. These forward-looking statements are based on the Company's expectations and are subject to a number of risks and uncertainties, many of which cannot be predicted or quantified and are beyond the Company's control. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying these forward-looking statements. Factors that could cause actual results to differ materially from the Company's expectations include the possibility that the favorable results received in the study may not be experienced by consumers, the inability to achieve widespread distribution of or the lack of market acceptance for Zicam(TM) Allergy Relief, the inability to accurately anticipate demand for products that are highly seasonal, which may result in delayed shipments if demand is greater than anticipated or in excess inventories if demand is less than anticipated, the Company's ability to produce sufficient quantities of Zicam(TM) Allergy Relief to meet current and anticipated demand, which could result in lower sales of these products, the inability to establish or support the efficacy of the claims made by the Company regarding the use of Zicam(TM) Allergy Relief, and the potential costs and delays associated with defending the patent infringement claim against Gel Tech seeking to prevent future sales of Zicam, which could divert the attention of management from ordinary business operations.
SOURCE: Gum Tech International, Inc. |
