Boston Therapeutics, Inc. Approved in France to Initiate a Clinical Trial With SUGARDOWN® in Patients With Type II Diabetes
Published: Dec 19, 2012
MANCHESTER, NH--(Marketwire - December 19, 2012) - Boston Therapeutics, Inc. (OTCQB: BTHE) ("Boston Therapeutics" or "the Company"), a leading developer of complex carbohydrate therapeutics to treat diabetes and inflammatory diseases, today announced that the French East IV Committee of Protection of Persons (Strasbourg) and the Ministry of Health has approved the Company's filing to initiate a clinical study of the efficacy and safety of SUGARDOWN®, taken together with a standard meal on post-meal sugar and insulin blood levels in patients with Type ll diabetes that have been treated with metformin. The Company expects similar applications to be filed in the U.S., Hong Kong and South Korea in 2013.
"In a clinical study, we saw significant reductions of post-meal elevation of blood sugar in healthy, non-diabetic patients who were overweight," said Dr. Hana Chen Walden, Consulting Medical Director, Boston Therapeutics. "It is important for people, especially those with diabetes, to control their blood sugar levels throughout the day. We believe SUGARDOWN® may help millions of people to better manage their blood sugar."
The Company plans to enroll 24 patients with Type ll diabetes in the French study and expects to start recruiting patients in January 2013, with an estimated total duration of six months (2 patients per cycle of 2 weeks). The primary endpoints of the dose escalating, placebo controlled study is to assess the efficacy and safety of SUGARDOWN® compared to treatment with metformin alone, to assess the effect on post-meal blood sugar levels, and to identify the average blood sugar and insulin concentrations.
SUGARDOWN® is a safe and effective dietary supplement that has been clinically proven to reduce the after meal elevation of blood sugar. Registered with the Food and Drug Administration (FDA), SUGARDOWN® is a chewable tablet that works in the stomach and intestines by blocking the enzymes that break down carbohydrates. Metformin is the most widely prescribed anti-diabetes drug in the world. In 2011, 59 million prescriptions were written for metformin in the U.S. In October 2012, the Company announced that the FDA had approved its petition to file an Abbreviated New Drug Application (ANDA) for a new, chewable tablet formulation of metformin.
About Boston Therapeutics, Inc.
Boston Therapeutics, a pharmaceutical company headquartered in Manchester, NH, (OTCQB: BTHE) is a leader in the field of complex carbohydrate drug design. The Company's initial product pipeline is focused on developing and commercializing therapeutic molecules for diabetes. The pipeline includes: SUGARDOWN®, a non-systemic chewable complex carbohydrate dietary supplement tablet designed to moderate post-meal blood glucose; BTI-7, a new, chewable dose form of the diabetes drug metformin hydrochloride; PAZ320, a non-systemic chewable therapeutic compound designed to reduce post-meal glucose elevation; and IPOXYN™, an injectable anti-necrosis drug specifically designed to treat lower limb ischemia associated with diabetes. More information is available at www.bostonti.com and www.sugardown.com.
The Company's views as of the date of this press release 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. 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," "believe" 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: incurrence of operating losses since our inception, uncertainty as to adequate financing of our operations, extensive and costly regulatory oversight that could restrict or prevent product commercialization, inability to achieve commercial product acceptance, inability to protect our intellectual property, dependence on strategic partnerships, product competition, and others stated in risk factors contained in our SEC filings. We cannot assure that we have identified all risks or that others may emerge which we do not anticipate. 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.
Boston Therapeutics, Inc.