MANCHESTER, NH--(Marketwired - Mar 4, 2014) - Boston Therapeutics, Inc. (OTCQB: BTHE) ("Boston Therapeutics" or "the Company"), an innovative developer of compounds that address diabetes using complex carbohydrate chemistry, has received Institutional Review Board (IRB) approval to initiate a clinical study of BTI-320 (previously named PAZ320) in the United States. The Company expects the trial to last for approximately three months. The U.S.-based trial is intended to mirror the Company's study of BTI-320 currently enrolling patients in France.
As with the France-based trial, the U.S. trial plans to enroll 24 patients with Type 2 diabetes who are currently being treated with metformin. These patients will be administered BTI-320 using a randomized, double-blind, placebo-controlled, dose-ranging, three-way cross-over study design. Patients' blood glucose will be monitored and their postprandial (after-meal) blood glucose levels will be measured following a test meal. The primary endpoint of the study is the evaluation of the effect of BTI-320 compared to placebo in the area under the curve (AUC) of glucose and secondarily, on insulin levels in the blood for four hours following intake of the meal.
According to the International Diabetes Federation, a body of evidence suggests that reducing post-meal plasma glucose excursions is as important, or perhaps more important for achieving HbA1c goals. The relationship between hyperglycemia and cardiovascular disease is complex with evidence suggesting that an acute increase of glycemia, may have a direct detrimental effect on cardiovascular disease, and that targeting both post-meal plasma glucose and fasting plasma glucose are important strategies for achieving optimal glycemic control.
Yael T. Bobruff, Ph.D., Clinical Affairs Manager, said, "As with our trial being conducted in France, this U.S. trial is designed to build upon the results from our Dartmouth Medical Center trial for BTI-320, published last year in the peer-reviewed journal Endocrine Practice. In the Dartmouth study, BTI-320 was well tolerated in patients taking various anti-diabetic agents, including metformin. The current clinical trials, which focus on patients taking only metformin, are the next steps in the investigation of this compound in patients living with Type 2 diabetes. We believe it is important to better control glucose levels throughout the day, given the many complications that stem from uncontrolled diabetes."
BTI-320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. 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 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 (formerly PAZ320), 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. SugarDown® is a non-systemic complex carbohydrate-based dietary food supplement designed to support healthy blood glucose. More information is available at www.bostonti.com.
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 the clinical trials are subject to factors beyond our control and provide no assurance of FDA approval of any of our future drug development plans. Our clinical trials may not produce positive results in a timely fashion, if at all, and any necessary changes during the course of the trial could prove time consuming and costly. We may have difficulty in enrolling candidates for testing, which would affect our estimates regarding timing, and we may not be able to achieve the desired results. Any significant delays or unanticipated costs in any subsequent drug trial could delay obtaining meaningful results from Phase II studies and/or preparing for Phase III studies with the current cash on hand.
Upon receipt of FDA approval, we may face competition with other drugs and treatments that are currently approved or those that are currently in development, which could have an adverse effect on our ability to achieve revenues from this proposed indication. Plans regarding development, approval and marketing of any of our compounds, including BTI320, are subject to change at any time based on the changing needs of our company as determined by management and regulatory agencies. To date, we have incurred operating losses since our inception, and our ability to successfully develop and market drugs may be affected by our ability to manage costs and finance our continuing operations. For a discussion of additional factors affecting our business, see our Annual Report on Form 10-K for the year ended December 31, 2012, and our subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause our views to change, we disclaim any obligation to update forward-looking statements.