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  • Leading Companies Being Defined In The Hunt For A NASH Treatment

    The race to develop a treatment for Non-Alcoholic Steatohepatitis (NYSEARCA:NASH) is getting a lot of airtime lately, pointing to the severity of the disease, poor prognosis and desperate need for a treatment. The space has only a handful of competitors, with most seeing rising valuations due to the tremendous peak sales that analysts are projecting for products that make it to market. What is particularly unique to this disease is not only the lack of any approved treatments, but also the influx of attention and growing broad body of research by companies like Intercept Pharmaceuticals (NASDAQ:ICPT), Galmed Pharmaceuticals (NASDAQ:GLMD) and Galectin Therapeutics (NASDAQ:GALT) that shows treatments are on the horizon, which gives these equities considerable upside.

    Intercept has been one of the biggest biotech stories of 2014, with shares mushrooming from around $70 to as high as $497 in January. The catalyst was the disclosure that an interim analysis of data from the Phase 2 FLINT trial of obeticholic acid (OCA) for NASH showed the drug to be performing so well that the trial was halted early as the primary endpoints were already met.

    The data showed that a once daily 25 mg oral dose of OCA in biopsy-proven adult NASH patients improved the NAFLD activity score (based on fat, ballooning hepatocytes, and inflammation) with no change in fibrosis, a milestone for not only Intercept, but also the industry. It was also a reason to stop giving the trial's placebo group a treatment that did nothing.

    Perhaps ironically, NASH is not even Intercept's lead indication for OCA, a bile acid analog and farnesoid X receptor agonist. The drug is also being developed as a second-line treatment for primary biliary cirrhosis (PBC). Data from the Phase 3 POISE trial for this indication was released this month showing that the drug hit its primary and secondary endpoints of reduction in serum alkaline phosphatase and improved liver function, respectively. The stock only rose 3% on the news and gave back all the gains (and then some) the next day. Pressure seemed to come from the need for a confirmatory trial to be conducted and analysts forecasting peak sales of less than $1 billion for PBC, compared to sales of a NASH drug that could be easily top $3 billion, keeping the focus on the NASH indication.

    Intercept said in its latest quarterly report that it expects the final results from the Phase 2 FLINT trial for NASH in July and to initiate a Phase 3 trial in the first half of 2015.

    Galmed is the newest biotech developing a NASH drug to hit the public domain, conducting its IPO on March 12 by offering 2.8 million shares at $13.50. Shares spiked as high as $18.75 on the first day of trading, but have cooled to around $11.50 currently. The little-known Israel-based company got a buzz going around it because of its oral drug candidate aramchol, a synthetic fatty acid and bile acid (FABC) conjugate scheduled to commence a Phase 2b trial for NASH patients also suffering from obesity and insulin resistance in the second half of this year. As shown by Intercept, positive mid-stage data for a NASH drug can certainly serve as a catalyst for a stock price. On that note, the results from the planned multi-center trial are expected in the second half of 2016.

    Clinical studies to date show aramchol to reduce liver fat content without any serious adverse side effects.

    Pegging NASH was a bit of an accident for Galmed. Aramchol was originally being developed (and still is) as a once-daily treatment to solubilize bile stones but was discovered to reduce liver fat infiltration in hamsters and mice with high-fat diets, so the target indication was expanded.

    NASH is a severe form of Non-Alcoholic Fatty Liver Disease (NAFLD), a condition that has become increasingly common in the United States. NAFLD in its simplest state is essentially benign, but as the condition worsens, NASH arises. The cause of NASH may still remain a mystery, but NAFLD commonly presents in patients with diabetes and obesity. With the skyrocketing diagnosis rate of those diseases, subsequently so goes the incidence rate of NAFLD and NASH. Further, NASH is also linked to increased risk of cardiovascular complications, a leading killer in North America. Sadly, liver fibrosis and NASH are not reversible and often lead to the necessity for a liver transplant, of which only about 6,000 actually happen each year.

    These facts make Galectin Therapeutics particularly attractive as early research shows its lead drug candidate GR-MD-02 to actually reverse fibrotic damage. Although the company may trail Intercept and Galmed in stage of human trials at this point, Galectin is only a clinical data set away from a potential leap forward with GR-MD-02. The drug is being developed under a "Fast Track" designation from the FDA, which provides an expedited developmental pathway as well as other benefits.

    Galectin is in a Phase 1 trial of GR-MD-02, a complex carbohydrate drug that targets and inhibits galectin-3, a key protein in the pathogenesis of fatty liver disease. A critical difference in the trial protocol is that Galectin is treating patients with NASH and advanced fibrosis, rather than earlier stages of the disease as other biotechs are. Moreover, in animal models, GR-MD-02 was shown to not only stop liver scarring from worsening; it showed the damage to start to be repaired.

    Shares of GALT got a brief bump on Tuesday when the company announced that it will be reporting results from the eight patients in the first cohort in the Phase 1 trial on Monday, March 31.

    Estimates show that up to 37 million adults in the U.S. have NASH, but this number could be conservatively low because the relatively asymptomatic disease often goes undetected until advanced stages. As estimates stand currently, nearly 10 million NASH patients will progress to develop liver cirrhosis. Halting the progression of fatty liver disease as Intercept has done is certainly a keystone moment in the overall genesis of new therapies, but tackling the disease as it reaches the often-terminal latter stages, as Galectin is aiming to do, will likely capture a far greater market share should regulatory approval be attained by both companies.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Additional disclosure: TDM Financial is a marketing and consulting firm that specializes in creating ongoing communications strategies for public and private companies. For full disclosure please visit: secfilings.com/Disclaimer.aspx

    Tags: GALT, Biotech
    Mar 27 10:15 AM | Link | Comment!
  • Boreal Water Targets The Chinese Market

    Premium bottled water consumption has been on the rise in China, driven by both increasing affluence and increasing health consciousness. According to beverage industry market research firm Canadean, China has doubled its share of the global bottled water market over the past seven years and topped U.S. bottled water consumption in 2013. These figures have ample room to grow given that China's per-capita consumption remains at just one-fifth of U.S. levels.

    Boreal Water Collection Inc. (OTC: BRWC) aims to capitalize on China's growth through a new distribution agreement with Suzhou Hengrun Import & Export Corp. Ltd. The new Chinese distributor will be debuting the company's award-winning premium bottled waters at the Sial China Show on May 13th through 15th 2014 in Shanghai. The trade show anticipates 2,400 exhibitors from 90 countries and regions that will present to more than 45,000 food and beverage professionals.

    In this article, we'll take a look at how the company is positioning itself to capitalize on rising demand in the world's most populous country.

    Rising Incomes & Safety Concerns

    China's gross domestic product ("GDP") per capita has been steadily rising over the past decade from under $1,000 in 2000 to over $6,000 in 2012. According to McKinsey & Company, more than 75% of the country's urban consumers will at least double their income to between $9,000 and $34,000 per year. The growth in the middle class means that sophisticated and seasoned shoppers will be able and willing to pay a premium for high-quality discretionary goods like water.

    The same report states that so-called "Generation 2" ("G2") middle-class consumers are the most Westernized to date. With a population of nearly 200 million consumers in 2012, the G2 group accounted for 15% of all urban consumption in 2012. These spending levels could more than double over the next ten years to 35%, as the group grows to three-times the size of the baby-boomer population that has been shaping U.S. consumption over the past few decades.

    In addition to rising incomes, China's middle class has been growing increasingly aware of health and safety issues related to water supply. China holds just 7% of the world's water supply despite housing about 20% of the global population. These shortages are compounded by the fact that more than half of the country's largest lakes and reservoirs were so contaminated in 2011 that they were unsuitable for human consumption by the government's own estimates.

    Companies like Coca-Cola Inc. (NYSE: KO) have already realized the potential with the launch of products like Ice Dew - one of the top-three Chinese bottled waters. If China reaches U.S.-levels of per-capita bottled water consumption, the existing market could grow five-times from its current levels. Boreal Water Collection aims to capitalize on these dynamics by targeting the niche private-label portion of the market with its award-winning waters from reservoirs in the U.S. and Canada.

    Unique Investment Opportunity

    Boreal Water Collection trades with a market capitalization of just $5.8 million, according to OTC Markets, with about 58 million shares in the float. With a new Chinese distributor onboard promoting its products, the company is well positioned to expand it revenues and move closer to a breakeven point in 2014 and 2015. At the same time, management has successfully reduced its liabilities by 40% in 2013 and put the company on more solid footing moving forward.

    "Since Boreal Water was highly qualified at the International Taste and Quality Institute in Belgium in 2012, the international demand for our products has increased," said Chairman and CEO Francine Lavoie in a letter to shareholders. "Boreal exhibited at the FHC China show in Shanghai in November 2013 and is expecting to start shipping in 2014 some large orders due to all the leads made at that show. In 2014 we will expand our presence in China and we will aggressively build our sales."

    In the end, investors may want to take a closer look at the company after its expansion into China's premium bottled water market. With a unique approach targeting private-label opportunities, the company is well positioned to establish itself in the world's most populous country with its award-winning products. In particular, investors in water stocks, like Coca-Cola or Pepsi-Co (NYSE: PEP), may want to take a closer look at Boreal Water as a niche play in the space.

    For more information, see the following resources:

    1. Company Website
    2. OTC Markets

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Additional disclosure: TDM Financial is a marketing and consulting firm that specializes in creating ongoing communications strategies for public and private companies. For full disclosure please visit: secfilings.com/Disclaimer.aspx

    Tags: BRWC, PEP, KO, Water
    Mar 25 9:30 AM | Link | Comment!
  • Breakthroughs On The Horizon For Chronic Traumatic Encephalopathy And Other Neurodegenerative Disease

    The quest to address long-term neurodegenerative problems associated with traumatic brain injury (NYSE:TBI) and concussions has received plenty of attention recently, in part because of high profile athletes raising awareness and also because of some breakthrough research by Boston University and the University of California at Los Angeles. With any advancement come arguments on both sides of the debate about the accuracy of statements without extensive clinical research, and the sobering reality is that there still are no reliable treatments for diseases like Alzheimer's disease and chronic traumatic encephalopathy (NASDAQ:CTE). All scientific posturing and argumentative rhetoric aside, the fact that companies are making strides in diagnostics and more resources are being devoted to these areas of tremendous unmet medical need are reason for optimism as there are new paths being carved in the evolution of new treatments.

    In the public domain, the majority of companies steer clear of neurological conditions because of the elusive nature of answers and the often non-linear progression of these diseases that can make research extremely challenging. The other side of that coin is that successful research can reap tremendous returns from both corporate and humanitarian perspectives. Companies like Neuralstem, Inc. (NYSE MKT: CUR) and Aethlon Medical, Inc. (OTCBB: AEMD) are not shying away from the challenge and appear to be making substantive progress.

    Neuralstem's lead drug candidate, a neural stem cell product called NSI-566, is a key driver for the company. It is in a phase 2 trial for Amyotrophic Lateral Sclerosis (ALS, or "Lou Gehrig's Disease), a disease where the progressive degeneration of motor neurons erodes communication between the brain, spinal cord and muscles, inevitably leading to death. Neuralstem is seeking a "Breakthrough Therapy" designation from the FDA for NSI-566 for ALS.

    More precise to this article's topic, Neuralstem has NSI-189, a small molecule that in November finished a phase 1b trial in patients with major depressive disorder (NYSEARCA:MDD) and is currently in the midst of a comprehensive data review expected to run through the second quarter. The drug is being developed with the understanding that MDD is no longer believed to be strictly a condition of brain chemistry, but also a physiology, including reduced hippocampal volume. Early research has shown NSI-189 to increase volume of the hippocampus (a home for neural stem cells that is known to atrophy in depression) by up to 20 percent, lending to the hypothesis that stimulating the genesis of new neurons in the hippocampus could treat depression with a different approach than the commonly used selective serotonin reuptake inhibitors. The company is also researching the molecule's effect on conditions like TBI, Alzheimer's and Post-Traumatic Stress Disorder.

    This physiological approach has captured the attention of the National Football League Alumni Association. Neuralstem and the NFLAA are working together on an initiative to develop NSI-189 as a new therapeutic to treat NFL alumni members suffering from traumatic brain injuries. Little development details have been disclosed, but as the data from the phase 1b trial for MDD is analyzed, it could lead to a significant step forward in TBI research at Neuralstem.

    Aethlon Medical's Adaptive Dialysis-like Affinity Platform Technology, or ADAPT for short, is the foundation for their flagship product, called the Hemopurifier®, an extracorporeal filtration device that has been shown to selectively and rapidly remove a wide array of viral pathogens, including HIV, and tumor-secreted exosomes from the circulatory system. The company is furthest along with Hepatitis C research. Aethlon disclosed late in February that it has partnered with contract research organization DaVita Clinical Research, a subsidiary of DaVita HealthCare Partners, to provide clinical management services to support additional upcoming clinical trials of the Hemopurifier in end-stage renal disease patients infected with Hepatitis C virus.

    Aethlon's medical device technology is complemented by the exosome expertise of its subsidiary Exosome Sciences Inc. From a broad perspective, research of exosomes, nano-size extracellular vesicles secreted by most every somatic cell and found in bodily fluids, is a rapidly emerging science that leading institutions, such as MD Anderson, have suggested could lead to revolutionary diagnostic tests. While MD Anderson is focused on oncology applications, recent discoveries indicate that exosomes could play a key role in diagnosing, and perhaps treating, degenerative brain conditions.

    Aethlon and Exosome Sciences have recently made a potential breakthrough by successfully isolating brain-specific biomarkers in the blood that are associated with a variety of neurodegenerative disorders. Because exosomes can pass through the blood/brain barrier, the microscopic cargo haulers can carry vital information about neurodegenerative conditions happening in the brain. The companies' research identified exosomes carrying brain-specific markers, including tau, beta-amyloid and other proteins. Tau is of particular interest in CTE research as the accumulation of tau is a hallmark of CTE, a disease often identified in soldiers exposed to blast injury and attributed to suicides of high-profile athletes Junior Seau, Dave Duerson and Andre Waters that can only be officially diagnosed in an autopsy.

    The potential to conduct a simple blood test to identify proteins that could implicate a condition like CTE or dementia at an early stage presents an opportunity for a new dynamic to identify and manage life-threatening and debilitating diseases. It also opens the door for innovative approaches as cornerstones to a new paradigm of research. This sort of research takes time, there is no denying that, but thanks to the efforts of organizations like Boston University and UCLA, funding support from the National Institute of Health, the National Football League and General Electric (NYSE: GE) and the pioneering efforts of companies like Neuralstem and Aethlon Medical, it's moving faster than ever before.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Additional disclosure: TDM Financial is a marketing and consulting firm that specializes in creating ongoing communications strategies for public and private companies. For full disclosure please visit: secfilings.com/Disclaimer.aspx

    Tags: AEMD, GE, Biotech
    Mar 13 1:02 PM | Link | Comment!
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