Boston Therapeutics, Inc. Reports Positive Phase ll Clinical Trial Results of PAZ320 in Patients With Type 2 Diabetes
Published: Feb 26, 2013
MANCHESTER, NH--(Marketwire - February 26, 2013) - 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 ll 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. 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.
The abstract for the clinical study is published in Epub ahead of print in PubMed website http://www.ncbi.nlm.nih.gov/pubmed/23425645 and the full article is expected to be published in the July/August issue of Endocrine Practice, a peer-reviewed journal.
Sushela S. Chaidarun, M.D., Department of Medicine, Section of Endocrinology, Dartmouth Medical Center and co-principal investigator for the study, said, "Type 2 diabetes is a growing concern given its rising prevalence. As uncontrolled diabetes can lead to micro- and macro-vascular complications, tighter but safe glycemic control is imperative. Optimal post-meal glucose control is one of the most difficult goals to achieve as Type 2 diabetes progresses, and PAZ320 may be helpful in achieving this goal. Its safety profile is reassuring."
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."
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 Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center (DHMC) is a nationally ranked academic medical center located in Lebanon, New Hampshire in the United States and includes the Dartmouth-Hitchcock Clinic and the Dartmouth Medical School, one of America's oldest and most respected medical schools.
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
Any statements in this news release about future expectations, plans and prospects for the Company constitute forward-looking statements as defined in the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those described in such statements.
More information about those risks and uncertainties is contained and discussed in the Company's most recent quarterly or annual report and in the Company's other reports filed with the Securities and Exchange Commission. The forward-looking statements represent the Company's views as of the date of this news release and should not be relied upon to represent the Company's views as of a subsequent date. While the Company anticipates that subsequent events may cause the Company's views to change, the Company disclaims any obligation to update such forward-looking statements.
Boston Therapeutics, Inc.
Director of Investor Relations