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.

This afternoon, we released a 60-page Executive Informational Overview on New Hampshire-based Boston Therapeutics, Inc. (BTHE-OTC).

Boston Therapeutics, Inc. (or “the Company”) develops products to address the diabetes and inflammatory disease markets using complex carbohydrate chemistry (CCC) technology. The Company’s portfolio includes two development-stage pharmaceutical candidates as well as a marketed over-the-counter (OTC) dietary supplement. The lead pharmaceutical candidate, BTI320 (formerly PAZ320), is a Phase II/III non-systemic, non-toxic, carbohydrate-based chewable tablet being evaluated as a therapy for Type 2 diabetes in patients currently taking metformin. The compound inhibits enzymes that release glucose from complex carbohydrates in foods during digestion—reducing the amount of glucose released from digested complex carbohydrates.

Boston Therapeutics’ second pipeline candidate is Ipoxyn™ (and a veterinary analog of Ipoxyn™, called OxyFex™), which is a carbohydrate-based intravenous solution in development to treat hypoxic conditions caused by a lack of oxygen to living tissue, such as lower-limb ischemia stemming from severe diabetes. The Ipoxyn™ molecule, which is 5,000 times smaller than a red blood cell (RBC), works by picking up oxygen in the lungs and offloading it to tissue that has been oxygen-deprived. The Company is positioned to benefit from two simultaneous paths to market—OTC and pharmaceutical drug development.

Key Points About Boston Therapeutics’ Business

• In a Phase IIa trial, BTI320 showed a 40% reduction in elevation of post-meal blood sugar with no serious adverse events. Enrollment in Phase IIb is underway, with the Company preparing for an IND filing with the FDA for a Phase III study.

Stem cell-based biotechnology company International Stem Cell Corporation (ISCO-OTC) will hold a conference call to update investors on its business and financial results on Wednesday, March 19, 2014. The call will cover results for the year ended December 31, 2013.

This morning, CardioComm Solutions, Inc. (EKG-TSX.V), a developer of software for informational management solutions used within the diagnostic cardiac and telemedicine markets, announced the receipt of an FDA Class II Medical Device Clearance for its proprietary GUAVA II ECG Viewer software.

Upon news that over the past two months, Massachusetts-based Pressure BioSciences, Inc. (PBIO-OTC) has raised an excess of $2.2 million, and seeks to raise more in February 2014, it is time to look closer at the business of this small-cap company. A quick Google search will tell you that Pressure BioSciences makes laboratory instruments for the “sample preparation” market—a market that is integral to life science research in tens of thousands of laboratories worldwide. But what is sample preparation? Is there a market for Pressure BioSciences’ products?

What is Sample Preparation?

We released a new report today--an Updated Executive Informational Overview--on AtheroNova Inc. (AHRO-OTC). AtheroNova is a clinical-stage biotechnology company focused on the research and development of bile acid therapeutic compounds to safely dissolve or regress atherosclerotic plaque and improve patients’ lipid profiles. Atherosclerotic plaque, a buildup of fat, cholesterol, and other substances in the walls of arteries, is the main underlying cause of cardiovascular disease, including heart attacks, strokes, and peripheral artery disease (PAD).

The Company’s most advanced candidate, AHRO-001, works to reduce the incidence and severity of plaque by employing a bile acid to reduce the volume of or stabilize existing plaque deposits and prevent new deposits from forming. The compound also shows significant preclinical lipid panel improvement and has beneficial effects on glucose levels involving multiple mechanisms of action.

If you missed the "Extending Life and Limb" workshop on regenerative medicine held last week at the OneMedForum conference in San Francisco, you can watch the full panel discussion on YouTube at the link below.

If you are in San Francisco today for the JP Morgan Healthcare Conference, the Biotech Showcase, or the 7th annual OneMedForum, we welcome you to stop by the Westin San Francisco on Market Street to visit our booth and hear Crystal Research CEO Jeffrey Kraws speak on regenerative medicine.

Crystal Research Associates is pleased to announce today that we have officially launched our mobile app and our new website. Take a look around at some of the changes...it is now easier than ever to sign up for research notifications and even start a discussion with us about your business's strategic needs. We have also recently expanded our line of products and services, which is now reflected throughout the site.