Boston Therapeutics (BTHE) is a pharmaceutical company focused on the development and commercialization of novel compounds based on complex carbohydrate chemistry to address unmet medical needs. An IP portfolio solidifies the company's position in the pharmaceutical industry. BTHE’s current product pipeline, PAZ320 and IPOXYNT, is comprised of therapies developed to treat patient populations with Type 2 diabetes.
PAZ320 is a non-systemic, non-toxic, chewable drug candidate for prevention of diabetes and its complications. PAZ320 inhibits the enzymes that release glucose from complex carbohydrate in foods during digestion. BTHE believes PAZ320 is a safe and effective drug compound for people with pre-diabetes and diabetes in their daily management of blood glucose levels, fulfilling an unmet medical need. PAZ320 has completed a Phase ll clinical trial at Dartmouth Medical Center. 45% of the patients responded with a 40% reduction in the elevation of post meal blood sugar compared to baseline with no serious adverse events.
IPOXYNT, a universal oxygen carrier, is an injectable Rx for prevention of necrosis and treatment of ischemic conditions which may lead to necrosis. This compound is not a biologic, but a second generation New Chemical Entity HBOC (hemoglobin based oxygen carrier). The potential for this product goes well beyond Lower Limb Ischemia into a range of areas from anemia and blood loss (injury), to cardiovascular disease and surgical blood supplementation.
- Lead Product Has Near-Term Opportunity in $35B Diabetes Drug Market
- Company Founder is World Renowned Scientist
- Recently Raised $5.3M to Enhance Drug Development Efforts
- Highly Experienced Management Team, Medical & Scientific Advisory Team
PAZ320 is a non-systemic, non-toxic, chewable drug candidate for prevention of diabetes and its complications. The drug compound is for people with pre-diabetes and diabetes in their daily management of blood glucose levels, fulfilling an unmet medical need. PAZ320 inhibits the enzymes that release glucose from complex carbohydrate in foods during digestion, reducing the amount of available glucose absorbed through the intestine.
The company believes this compound may provide individuals with a means by which to slow the onset of Type 2 diabetes and/or the onset of diabetes complications such as heart disease, stroke, kidney damage, retinopathy and Diabetic Foot.
BTHE’s Phase 2 clinical trial evaluating PAZ320 in 24 patients with Type 2 diabetes shows that 45% of patients responded with a 40% 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.
In Q2 2013, BTHE filed for an IND application meeting with the Food & Drug Administration (FDA); discussions continue regarding the trial design for the company’s international Phase 3 PAZ320 trial for patients with Type 2 diabetes.
PAZ320 will require FDA approval for marketing as a drug and will be subject to extensive regulation by governmental authorities in the United States and other countries.
IPOXYN™, a universal oxygen carrier, is an injectable Rx for prevention of necrosis and treatment of ischemic conditions which may lead to necrosis. IPOXYN™ oxygen carriers are in pre-clinical stage of drug development.
Necrosis occurs following ischemia (shortage of oxygen supply to the tissue due to restriction in blood supply). The only treatment available at present for necrosis is providing oxygen by a high pressure facility. Thus, there is a crucial need to develop drugs for prevention and treatment of this pathology.
Limb ischemia is a chronic condition of severe obstruction of the peripheral circulation that results in severe pain in the extremities. Due to the constriction of blood vessels, especially capillaries, red blood cells (RBCs) are unable to flow through them and this disruption in the microcirculation leads to the deprivation of oxygen, or ischemia. Complications include gangrenous sores and wounds that won’t heal, typically in the legs and feet. If left untreated, these lesions can result in amputation of the affected limb. Lower limb ischemia is a life-threatening complication for patients with poorly-controlled diabetes and affects 10% of the diabetic population.
For decades, oxygen carriers have been developed for perfusion and oxygenation of ischemic tissue. None have yet succeeded. These products failed to secure FDA approval based upon either poor outcomes in clinical trials or poorly formulated product.
Boston Therapeutics’ Approach
BTHE’s injectable drug, IPOXYN™ is a New Chemical Entity (NCE) and not a biologic blood substitute. A significant improvement over hemoglobin-based oxygen carriers (HBOCs), IPOXYN™ prevents methemoglobin formation associated with the adverse effects of vasoconstriction and myocardial infarction. Furthermore, because of IPOXYN™’s extremely small molecular size, roughly 1/5,000th the size of an RBC, IPOXYN™ is able to perfuse constricted, ischemic capillaries which are inaccessible to RBCs. This small molecular size has particular significance in treating vascular complications of diabetes since RBCs may already be enlarged and lower limb vasculature may be compromised.
OxyFex™ is BTHE’s veterinary facsimile to Ipoxyn™. There is currently an unmet need in the veterinary market for blood replacement and oxygen delivery to damaged or ischemic tissue due to trauma, surgery anemia, and other disease conditions.
Diabetes affects 25.8 million people, or 8.3% of the U.S. population, according to the Center for Disease Control (CDC). The disease is the No. 1 cause of kidney failure, nontraumatic lower-limb amputations, and new cases of blindness among adults in the United States.
In the 20-year span of 1990-2010, the annual number of new cases of diagnosed diabetes nearly tripled. The rise in the incidence of type 2 diabetes cases is associated with increases in obesity, decreases in leisure-time physical activity, and the aging of the U.S. population.
By 2018, the worldwide diabetes drug market is expected to grow to $58 billion, up from its current $35 billion.
Total estimated costs of diagnosed diabetes for 2012 is $245 billion, representing an increase of 10% spent directly on diabetes and its complications, and an increase of 20% spent on caring for people with diagnosed diabetes.
BTHE is focused on reversing the rising trend of Type 2 diabetes. PAZ320 has demonstrated a strong safety profile with no serious adverse events (SAE). BTHE’s drug candidate works specifically in the individual’s gastrointestinal track while other diabetes drugs involve interaction with the liver, kidney, pancreas and cells, placing these systems with an unnecessary risk for SAE. PAZ320’s innovative position provides a competitive advantage compared to other anti-diabetic drugs.
As BTHE continues to develop its product pipeline, the company has set out several key objectives for advancement in upcoming years.
The BTHE management and advisory team has extensive expertise in complex carbohydrate chemistry, regulatory affairs, and clinical development, with multiple submissions and approvals to U.S. Food and Drug Administration. Backed by a team with more than five decades of expertise in public and private business management, the company is well positioned to advance its status as a premier developer of complex carbohydrate-based new chemical entities.
David Platt, Ph.D. - Chairman, Chief Executive Officer, Chief Financial Officer and Director
Dr. David Platt is a world-renown expert in carbohydrate chemistry and has founded three publicly traded companies, creating nearly $1 billion for investors. He has lead two drug candidates from concept to human clinical trials. Prior to Boston Therapeutics, from 2001 to 2009, Dr. Platt was a founder, CEO and chairman of the board at Pro-Pharmaceuticals, Inc., SafeScience, Inc. and International Gene Group, all publicly traded companies.
Kenneth A. Tassey, Jr. - President and Director
Kenneth Tassey has served as president of Boston Therapeutics since November 2010. Prior to that, Mr. Tassey co-founded Boston Therapeutics, Inc. and served as CEO and president since its inception in June 2009 and until its merger with Avanyx Therapeutics. From 2007 to 2009, Tassey was president of TKCI, a consulting firm for commercial finance projects. Prior to TKCI, from 2005 to 2007, Tassey served as president of Liberty Shore LLC, as a consultant to businesses and to commercial and residential lenders. Tassey has a background in business management and operations.
Carl L. Lueders - Audit Committee Chairman and Director
Carl Lueders has been a director of Boston Therapeutics since September 2009, has a broad range of experience in finance and operations, short- and long-term planning, forecasting, performance measurement, SEC reporting, and controls. He was CFO for Micronetics, Inc. a manufacturer of microwave and radio frequency products for commercial wireless, defense and aerospace products. Prior to that, he was CFO for Pro-Pharmaceuticals and before that CFO for R.F. Morse & Son, a privately held agri-based company. Prior to that Lueders spent 22 years with publicly held Polaroid in various finance positions, including vice president and controller, Treasurer and acting CFO. Lueders is a CPA and received his B.A. in economics from the University of Massachusetts at Amherst and his MBA from Babson College.
Dale H. Conaway, D.V.M. - Director
Dr. Dale Conaway, a Director of Boston Therapeutics since September 2009, is the chief veterinary medical officer for the Office of Research Oversight, an office within the Veterans Health Administration under the U.S. Department of Veterans Affairs. From 2001 to 2006, Dr. Conaway was the deputy regional director (Southern Region). From 1998 to 2001, Dr. Conaway served as manager of the Equine Drug Testing and Animal Disease Surveillance Laboratories for the Michigan Department of Agriculture. From 1994 to 1998, he was regulatory affairs manager for the Michigan Department of Public Health Vaccine Production Division. Dr. Conaway received a DVM degree from Tuskegee Institute and an MS degree in pathology from the College of Veterinary Medicine at Michigan State University.
Henry J. Esber, Ph.D. - Director
Dr. Henry Esber, has been a principal in Esber D&D consulting since 2005. From 2003 to 2005, Dr. Esber was a senior consultant, Business Development at Charles River Labs, Discovery and Development Services. From 2005 to 2006, Dr. Esber was a consultant and from 2006, he was senior vice president and chief business officer for Bio-Quant. Dr. Esber is the co-founder of BioSignature Diagnostics, Inc. and Advanced Drug Delivery, Inc.
Dr. Rom E. Eliaz, Ph.D., MBA - Director
Dr. Rom Eliaz, a director of Boston Therapeutics since September 2009, has been a CEO of Nasvax, an Israel-based biotech company and president and CEO of JJ Pharma Inc. since September 2009. He has also been CEO and managing director, Elrom Ventures Corp. since May 2007. From January 2007 to October 2007 Dr. Eliaz was a senior director of development at, Intradigm Corp. From March 2004 to December 2006 Dr. Eliaz was a director of development, Pfizer Inc., (Rinat Neuroscience).