Previously Reported Data Showed That PAZ320 Demonstrated 40% Reduction in the Elevation of Post Meal Blood Glucose With No Serious Adverse Events
MANCHESTER, NH -- (Marketwired) -- 09/04/13 -- Boston Therapeutics, Inc. (OTCQB: BTHE) ("Boston Therapeutics" or "the Company"), a developer of complex carbohydrates to treat diabetes and inflammatory diseases, reports positive results from a Phase II clinical trial that evaluated the safety and efficacy of PAZ320, a complex carbohydrate-based drug designed to reduce the elevation of post-meal blood glucose by blocking the action of carbohydrate-hydrolyzing enzymes is published in the July/August issue of Endocrine Practice, a peer-reviewed journal.
As previously reported, the study evaluated PAZ320 in 24 patients with Type 2 diabetes between the ages of 18 and 75 with a body mass index (BMI) of 25-40 kg/m2 and with HbA1c of less than or equal to nine percent. HbA1c is a lab test that shows the average level of blood sugar (glucose) over the previous three months.
Forty-five percent of patients responded with a 40 percent reduction of post-meal glucose in the blood compared to baseline in a dose-dependent manner. Additionally, results showed the effect of PAZ320 does not correlate with duration of diabetes and works regardless of concurrent diabetes medications. There was no severe hypoglycemia and gastrointestinal side effects were mild. Satiety was also observed. There were no serious adverse events from the data analysis of the open-label dose escalation crossover trial on Type 2 diabetic patients.
David Platt, Ph.D., Chairman and Chief Executive Officer of Boston Therapeutics, said, "These results are very promising. When clinical trial testing is complete, we believe that PAZ320 will be found to be an effective treatment for millions of people who have high blood sugar and diabetes. Given the many complications that stem from uncontrolled diabetes, it is important to better control glucose levels throughout the day."
The published study is available at: http://www.endocrinepractice.org.
PAZ320 is a non-systemic chewable complex carbohydrate-based compound designed to reduce post-meal elevation of blood glucose. PAZ320 is a proprietary polysaccharide designed to be taken before meals and works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down carbohydrates into glucose and release it into the bloodstream.
About Boston Therapeutics, Inc.
Boston Therapeutics, headquartered in Manchester, NH, (OTCQB: BTHE) is a pharmaceutical company focused on the development, manufacture and commercialization of novel compounds based on complex carbohydrate chemistry to address unmet medical needs in the areas of diabetes and inflammatory diseases. The Company's initial product pipeline is focused on developing and commercializing: PAZ320, a non-systemic therapeutic compound designed to reduce post-meal glucose elevation, and IPOXYN™, an injectable anti-necrosis drug designed to treat ischemia. 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 our 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 the trials could delay obtaining meaningful results from Phase II and/or preparing for Phase III 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 drugs, including PAZ320, 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.
Source: Boston Therapeutics