Advance Pharmaceutical Company Ltd. to Fund Study Evaluating Effect of SUGARDOWN(R) on Post-Prandial Hyperglycemia in High-Risk Chinese Subjects With Pre-Diabetes; 300 Million People in China Are Considered Pre-Diabetic or Diabetic
MANCHESTER, NH -- (Marketwired) -- 01/27/15 -- Boston Therapeutics, Inc. (OTCQB: BTHE) today announced that its Hong Kong affiliate, Advance Pharmaceutical Company, Ltd. (APC), received a signed certificate from the Department of Health to initiate a clinical trial at The Chinese University of Hong Kong (CUHK) evaluating SUGARDOWN® in subjects with pre-diabetes. The clinical trial is expected to start this quarter.
David Platt, Ph.D., CEO of Boston Therapeutics, said, "We are eager to learn more about the effects of SUGARDOWN® on individuals with pre-diabetes and are confident we will collect key information as a result of this study. We are happy to have the support of APC for this study, and look forward to potentially helping diabetes and pre-diabetes patients in China."
Boston Therapeutics developed SUGARDOWN® and markets it through APC in Asia and Benchworks in North America. SUGARDOWN® is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. SUGARDOWN® is a proprietary polysaccharide to be taken before meals and works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down complex carbohydrates into simple sugars, reducing the availability of glucose for absorption into the bloodstream.
The single-center, 16-week, randomized, double-blind, placebo-controlled, three-treatment arm pilot trial, to be funded by APC, is designed to evaluate the tolerability, safety and efficacy of SUGARDOWN® in high-risk Chinese subjects with pre-diabetes. The primary endpoint is change in serum fructosamine in subjects treated with low-dose SUGARDOWN® and high-dose SUGARDOWN® compared with placebo from baseline to Week 4. The secondary endpoints include changes in Area Under the Curve_180 and HbA1c in subjects treated with low-dose SUGARDOWN® and high-dose SUGARDOWN® compared with placebo from baseline to Week 4 and Week 16. Changes in HbA1c in subjects treated with low-dose SUGARDOWN® and high-dose SUGARDOWN® compared with placebo from baseline to Week 16. A total of 60 subjects will be recruited for the trial.
Dr. Juliana CN Chan, PRCP is the lead principal investigator and the lead clinical site is the Department of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital.
SUGARDOWN® will be administered as an oral chewable tablet containing either four grams of SUGARDOWN® or matching placebo. All subjects will be instructed to take two chewable tablets prior to meal ingestion. Low-dose SUGARDOWN® consists of one active chewable tablet and one placebo chewable tablet; high-dose SUGARDOWN® consists of two active chewable tablets.
Obesity and Fructose/ Serum Fructosamine
Obesity is a major epidemic and excessive consumption of high-fructose corn syrup (HFCS) in beverages plays a role. The consumption of HFCS increased dramatically in the last several decades. Today, HFCS represents a significant portion of caloric sweeteners added to foods and beverages and is a caloric sweetener used in soft drinks. Sucrose is part glucose and part fructose. These are two "sugars," one the body uses for energy and the other is made into fat if not utilized and converted into glucose. The digestion, absorption, and metabolism of fructose differs from the metabolism of glucose. In addition, unlike glucose, fructose does not stimulate insulin secretion or enhance leptin production (the hormone that signals us to stop eating). Because insulin and leptin act as key afferent signals in the regulation of food intake and body weight, this suggests that fructose may contribute to increased energy intake and weight gain. Furthermore, calorically sweetened beverages may enhance caloric overconsumption. Thus, the increase in consumption of HFCS has a temporal relation to the epidemic of obesity, and the overconsumption of HFCS in calorically sweetened beverages may play a role in the epidemic of obesity.
About Advance Pharmaceutical Company, Ltd.
Advance Pharmaceutical Company is a leading Hong Kong-based pharmaceutical company. Advance Pharmaceutical Company currently sells over 400 types of licensed pharmaceutical products, consisting of prescription and over the counter products to local dispensaries, medicine shops, clinics and hospitals, as well as chain stores, such as 7-11, Wellcome, Park-N-Shop, Mannings and Watson's. Outside of Hong Kong, Advance Pharmaceutical Company has been building and maintaining its marketing network in Macau since 1983 and has many years of experience in exporting and distributing pharmaceutical products to China. Currently, Advance Pharmaceutical Company's products penetrate 90% of dispensaries and drug stores in Macau. Additional information is available at http://www.apc.com.hk/aboutus.php.
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is an innovator in designing compounds using complex carbohydrate chemistry. The company's product pipeline is focused on developing and commercializing therapeutic molecules that address diabetes and inflammatory diseases, including: SUGARDOWN®, a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN, an injectable anti-necrosis drug designed initially to treat lower limb ischemia associated with diabetes. The company also developed and markets sugardown®, a non-systemic complex carbohydrate-based dietary food supplement designed to support healthy blood glucose. More information is available at www.bostonti.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains, in addition to historical information, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as "May," "estimate," "could," "expect" and others. They are based on our current expectations and are subject to factors and uncertainties which could cause actual results to differ materially from those described in the statements. Factors that could cause our actual performance to differ materially from those discussed in the forward-looking statements include, among others, that our plans, expectations and goals regarding our clinical development of SUGARDOWN® are subject to factors beyond our control. We can provide no assurance we or our commercial partner will be able to generate market demand for sugardown®, and thus we may not be able to generate revenue from sugardown® sales.
Moreover, we have incurred operating losses since our inception, and our ability to successfully develop, market, manufacture, distribute and sell drugs or over-the-counter products may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional risk and other factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2013, and our subsequent filings with the SEC.
You should not place undue reliance on forward-looking statements, and actual results may differ materially from the results anticipated in our forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.
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Source: Boston Therapeutics