Experienced Research Program in the University at Buffalo's Center of Excellence for Bioinformatics and Life Sciences to Evaluate the Effect of BTI-320 on HbA1c in General Population and Asian Subjects With Diabetics and Pre-Diabetes
MANCHESTER, NH -- (Marketwired) -- 05/28/15 -- Boston Therapeutics, Inc. (OTCQB: BTHE) signed a Letter of Intent with Dr. Gene D. Morse, Director of the Translational Pharmacology Research Core in the University at Buffalo's Center of Excellence for Bioinformatics and Life Sciences (CBLS) to potentially collaborate on an enrollment program for a preventative clinical trials initiative at several locations in Buffalo, NY and New York City's Chinatown. The purpose of this collaboration initiative is to evaluate the effects of BTI-320 on an individual's HbA1c levels, in particular, who are diabetic and pre-diabetic. HbA1c test provides an overall measurement of blood sugar levels over two to three months.
David Platt, Ph.D., CEO of Boston Therapeutics, said, "We are moving forward in our key strategic development demonstrating the effects of the BTI-320 formulation on individuals who are pre-diabetic and of higher body mass index. We expect these study results to confirm and contribute to the growing body of evidence building on the test results of our two Sydney University Australia trials, where post prandial reductions in both insulin response and glucose response were reported in all of the participants. We are pleased to have established this working relationship with UB's CBLS for the opportunity of this alliance, and look forward to reporting the results. In western New York, it is estimated that approximately 10% of adults have diabetes and 30% are pre-diabetic and the numbers are even higher in Chinatown, where estimates are approximately 30% of adults have diabetes and 50% are pre-diabetic."
The single-center, 16-week, randomized, double-blind, placebo-controlled, three-treatment arm pilot trial, is expected to be funded by BTI, and is designed to evaluate the proof of concept for post prandial glucose management, safety and efficacy of BTI-320 in high-risk general population and Asian subjects with pre-diabetic conditions. The primary endpoint is change in serum fructosamine (indication of glycation of serum proteins) in subjects treated with a variable-dose of BTI-320 compared with placebo from baseline to week 4. The secondary endpoints include changes in Area Under the Curve_180 (with continuous monitoring) and HbA1c in subjects from baseline to week 4 and week 16, and changes in HbA1c in subjects compared with placebo from baseline to week 16. A total of 60 subjects are expected to be recruited for the trial.
Dr. Gene D. Morse, SUNY Distinguished Professor and Associate Director of UB's CBLS has formed a collaboration with Boston Therapeutics during the clinical research planning for BTI's complex carbohydrate research program. Dr. Morse, Director of the Translational Pharmacology Research Core (TPRC) in the CBLS, has extensive experience with designing, implementing and analyzing clinical trials. The collaboration with BTI will create a research coordinating center at the TPRC and foster interactions with UB's Clinical and Translational Research Center and the TPRC, as well as Practice-based Research Networks in upstate New York. The clinical trials will investigate the efficacy of BTI-320 and be conducted at collaborating research sites in upstate New York and in research centers that are part of an emerging collaboration with New York City practitioners.
"The mission of this strategic strength is to develop an interacting matrix of research, teaching and service activities involving basic and clinical biomedical sciences, social science, nursing, public health, education, epidemiology, law, communication, information and engineering technology, architecture, economics, and perhaps other academic disciplines that can improve health, independence and quality of life in individuals and the western New York population throughout the life span," said Dr. Morse.
Obesity and Fructose/ Serum Fructosamine
Obesity is a major epidemic and excessive consumption of high-fructose corn syrup (HFCS) in beverages as well as many food stuffs play a role in the immediate post prandial increases in blood glucose levels. The consumption of HFCS and the processing food to remove fiber have permitted high immediate post consumption of easily absorbed sugar. This has created a dramatic increase in the daily easy and convenient consumption of excess glucose and fructose. Today, HFCS and fast convenience foods represent a significant portion of caloric intake from foods and beverages. Primarily the caloric sweetener used in soft drinks and the fiber less source of sugar from otherwise healthy fruit juices. 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. Additionally increased insulin response signals the body to store sugars as fat. 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.
BTI-320 will be administered as an oral chewable tablet containing either four grams of BTI-320 or matching placebo. All subjects will be instructed to take two chewable tablets prior to meal ingestion. Low-dose BTI-320 consists of one active chewable tablet and one placebo chewable tablet; high-dose BTI-320 consists of two active chewable tablets.
BTI-320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. It also has been indicated in a reduction of insulin response in high body mass index individuals. BTI-320 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.
About UB Center of Excellence for Bioinformatics and Life Sciences
The CBLS fosters economic development by facilitating innovations that drive the growth of life sciences and related high-tech industry. Through funding, research and development, programming and education, we are helping companies find business solutions, accelerate new ideas, and grow by connecting with university resources.
As the designated life sciences center of excellence, CBLS is at the heart of Buffalo's life sciences hub and combine expertise from research and academic institutions that have been around for more than 100 years. With the University at Buffalo (UB), as the lead organization, the Center provides access to other important resources such as the recently launched NYS Center of Excellence in Materials Informatics (CMI) at UB, the UB Center for Advanced Biomedical and Bioengineering Technology (UB CAT) and two research partners, Roswell Park Cancer Institute and Hauptman-Woodward Medical Research Institute.
The Center and its research partners reside in 400,000 square feet of state-of-the-art research facilities in three new interconnected buildings, known as the Buffalo Life Sciences Complex, on the Buffalo Niagara Medical Campus, which is a thriving area of clinical, research and academic operations employing over 8,000 people daily. The Center includes more than 100 scientists with biological, physical and computational expertise engaged in interdisciplinary translational research with Center collaborators.
Bioinformatics, Life Sciences, Economic Development, Government/Academia/Industry Collaboration
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: BTI-320, a non-systemic chewable therapeutic compounds 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 BTI-320 and 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, 2014, and our subsequent filings with the SEC.
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Source: Boston Therapeutics