Pharmaceutical company Boston Therapeutics, Inc. (BTHE-OTC) announced today that it would be making an important presentation at the American Association of Clinical Endocrinologists’ (AACE) 23^rd Annual Scientific and Clinical Congress in May 2014. The presentation will center on a late-breaking poster for the company’s lead product candidate, BTI320, which is a non-systemic, non-toxic, plant-based chewable tablet being evaluated as a therapy for Type 2 diabetes patients taking metformin.
 
What: the AACE 23^rd Annual Scientific and Clinical Congress
Where: Paris Las Vegas Hotel in Las Vegas, Nevada
When: May 14-18, 2014
Boston Therapeutics’ Presentation: Sat., May 17 from 9:45 to 11:00 AM
For more details or to attend: http://am.aace.com/
 
Boston Therapeutics’ AACE poster addresses the viability of BTI320 as a treatment for glycemic control, and is focused on the molecular mechanism of action of this product candidate.
 
About BTI320 for Diabetes
 
The BTI320 compound—which is currently in Phase II trials—works in the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down carbohydrates into glucose. This reduces the amount of glucose available for absorption into the bloodstream. The majority of anti-diabetes drugs on the market today—hypoglycemic drugs—force blood sugar levels down systemically by targeting organs, such as the pancreas and other cells within the body. This can increase the risk of side effects, as has been shown in recent Food and Drug Administration (FDA) findings. In contrast, BTI320 offers a preemptive approach to blood sugar management by targeting enzymes in the mouth and small intestine to reduce the uptake of glucose during the digestion of carbohydrate foods—which may provide for an improved safety profile.
 
The active ingredient in BTI320 is mannan. Mannans are a group of plant-derived complex carbohydrates, or polysaccharides, which consist mainly of polymers of the sugar mannose. Some of the plants from which mannans are derived include guar, locust bean, fenugreek, barley, and konjac. Published studies on mannans have shown that they possess significant biological activity—ranging from inhibiting cholesterol absorption, promoting wound healing, and inhibiting tumor growth. Studies have also shown that consuming mannan before a meal can reduce the rise in blood glucose subsequent to that meal. Therefore, supplementation with mannan may be beneficial in the management of diabetes by supporting healthy blood sugar levels.
 
The Company entered into a clinical trial at Dartmouth Medical Center in Lebanon, New Hampshire, for BTI320 to measure post-prandial elevation of blood glucose. The goal was to leverage data from this study in the marketing of BTI320. This Phase IIa trial, with results recently published in the peer-reviewed journal Endocrine Practice, showed that BTI320 was well tolerated in patients taking various anti-diabetic agents, including metformin.
 
BTI320’s safety profile has reduced risk due to its Generally Recognized as Safe (GRAS) classification, and as well, has a 505(b)(2) accelerated development pathway for FDA approval. This route permits companies to obtain FDA approval of New Drug Applications (NDAs) by relying, in part, on the FDA’s findings for a previously approved drug. The benefits are many as this method may provide for a more expeditious way of achieving approval for product candidates by employing third-party data in support of a company’s own clinical studies.

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This afternoon, we released a new Executive Informational Overview (EIO) on MetaStat, Inc. (MTST-OTC). This comprehensive, 68-page document updates an earlier EIO published on MetaStat in January 2013. The Company has achieved several significant milestones over the past year and a half, which are each detailed in the new EIO along with current product development and market descriptions for MetaStat’s diagnostic and therapeutic programs.

MetaStat is a life sciences company commercializing a new approach to reliably determine a patient’s individual risk of developing systemic metastatic cancer, and then to help reduce this risk through active intervention of the metastatic process. The Company’s technology is based on a proprietary knowledge of the mechanisms that govern “metastasis” (the spread of cancer away from its primary site in the body).

The technology centers on the role of the Mena protein in tumors, and has over 15 years of study from major medical institutions including MIT, the Albert Einstein College of Medicine of Yeshiva University, Cornell University, and the IFO-Regina Elena Cancer Institute. Recent clinical studies validating MetaStat’s product candidates have also been performed by the Yale University School of Medicine, the University of Toronto, and others.

MetaStat is initially advancing two diagnostic platforms targeting breast, prostate, lung, and colorectal cancers, which could enter the market as early as 2015, as well as a therapeutic program.

• MetaSite Breast. MetaSite Breast is a clinical laboratory assay (or test) to predict the likelihood of an early-stage breast cancer patient’s tumor spreading to distant body parts. An important distinction between MetaStat’s technology and whole genome-based assays such as Oncotype DX® and other approaches is that MetaStat focuses on predicting the risk of cancer metastasis based on the tumor’s underlying mechanisms. Historically, cancer cells have entered the blood vessels via unknown means. The research supporting the Company’s technology has sought to identify the structural and behavioral mechanisms that allow cancer cells to move and determine how this information can be used in prognosis. To MetaStat’s knowledge, its technology is the only technique to focus on such mechanistic markers. 

• MenaCalc. The MenaCalc diagnostic technology platform is intended for use in determining individual levels of variants of the Mena protein (called “Mena isoforms”) in cancer tissue. Mena has at least five isoforms, and measuring the relationship between these variants can help create an individual metastatic profile as early on in disease progression as possible. Over time, patients’ Mena isoform profiles could identify trends and detect stability or progression of disease as well as detect the efficacy of various therapies in real time. MetaStat is developing multiple product candidates based on the MenaCalc platform to target common epithelial cancers: (1) MenaCalc Breast; (2) MenaCalc Lung; (3) MenaCalc Prostate; and (4) MenaCalc Colorectal. 

• MenaBloc. As evidenced by the high mortality rate of metastatic cancers, there is an unmet medical need for therapies based on a solid understanding of the process of metastatic disease, including techniques to kill or stop the spread of metastatic cancer cells or to disrupt individual steps in the metastatic process. A MenaBloc therapeutic may ultimately prevent metastasis among high-risk patients when it is administered as a maintenance therapy after surgery or in conjunction with chemotherapy and other targeted therapies. In December 2013, MetaStat licensed a collection of alternatively spliced therapeutic targets that have a role in the epithelial to mesenchymal transition (EMT) of tumor cells. EMT is an early event in the metastatic process, which also contributes to therapeutic resistance in breast and other cancers. MetaStat believes this discovery presents a novel opportunity for new cancer therapeutics that target alternatively spliced oncogenes. 

The Company believes that its function-based diagnostics can inform better treatment decisions by identifying patients with a high risk of systemic metastasis who need aggressive therapy and sparing patients with a low risk of metastasis from painful and costly therapies. The National Institutes of Health (NIH) recently concluded that a primary goal in cancer research should be to accurately define patient risk categories with the goal of being able to administer the level of treatment needed for a successful outcome. 

Milestones and Report Topics

Click here to download and read the full Executive Informational Overview, which includes a discussion of the recent milestones listed below. 

• Initial sales and marketing plans for MetaSite Breast, which is anticipated to commence sales in 2015
• MetaStat’s December 2013 presentation of results from a large-scale study of its MetaSite Breast test at the San Antonio Breast Cancer Symposium
• Results of a clinical validation of the MenaCalc technology presented at the 2014 Annual Meeting of the U.S. and Canadian Academy of Pathology
• The October 2013 opening of a drug discovery laboratory in affiliation with Stony Brook University
• Recent license agreements with MIT and other institutions for the use of alternatively spliced mRNA and protein isoform markers in the diagnosis, prognosis, and treatment of metastatic, epithelial-based solid tumors—which is central to the Company’s ongoing MenaBloc therapeutic development
• Additions to executive leadership that include a former senior executive from Roche as MetaStat’s new Head of Diagnostics
• Establishment of a highly skilled Scientific Advisory Board for Therapeutics, which includes individuals from Duke University and the Duke-NUS Medical School, the Dana-Farber Cancer Institute, the Cold Spring Harbor Laboratory, and MIT
• Current patent position and strategies
• Most recent historical financial position and fundraising goals

Pressure BioSciences, Inc. (PBIO-OTC), a company that develops, markets, and sells proprietary laboratory instrumentation and associated consumables to the estimated $6 billion life sciences sample preparation market, announced financial results for the three-month period and fiscal year ended December 31, 2013, and provided a business update.