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  • Bank Of America Investment Report Highlights The Value In 22nd Century Group

    Early this week, Bank of America/Merrill Lynch published an analyst report on Modified Risk Tobacco Products (MRTPs) detailing the significant impact that MRTPs will have on the $748 billion annual worldwide tobacco industry. "We are on the eve of what we all believe could be a paradigm shift for our industry," Philip Morris International (NYSE: PM) CEO, Louis Camilleri was quoted. The new products have "the very real potential to not only be a game-changer, but also be the key to unlock several hitherto virgin territories, most notably the huge Chinese market."

    Indeed MRTPs could revolutionize the tobacco industry and generate untold profits for the most innovative, consumer-acceptable products. BOA goes into great detail describing "Modified Smoking" products which mimic smoking such as e-cigarettes and heat, not burn, products, and "Alternatives to Smoking" such as snus, dissolvables and nicotine replacement products. Examples are these products are marketed at Lorillard Inc. (NYSE: LO) and Reynolds American Inc. (NYSE: RAI).

    Yet history has shown that the world's one billion smokers are not attracted to the exotic MRTPs catalogued in the BOA report. According to the report, traditional combustible cigarettes account for 92% of the value of all tobacco products sold worldwide. Simply stated: smokers prefer combustible cigarettes and are highly attracted to cigarettes that are potentially less harmful. Yet remarkably, the BOA analyst report does not comment on technology that addresses the 6 trillion cigarettes smoked every year.

    As with many analyst reports covering blue chip companies, Bank of America seems to have overlooked one of the most compelling companies in the space that has headroom for tremendous growth that may be unprecedented compared to goliaths in the tobacco industry. The tiny microcap? A biotechnology-tobacco hybrid, 22nd Century Group, Inc. (OTCBB: XXII). What gives under-the-radar 22nd Century Group credibility? Well, with over 100 patents, mainly on the genes in the tobacco plant that regulate nicotine production, 22nd Century is the only company in the world with the technology to provide the U.S. National Institutes of Health research cigarettes containing an entire spectrum of nicotine content: from very low to high.

    A peer-reviewed research paper just published this week by lead-author Dr. Dorothy K. Hatsukami, a member of the FDA's Tobacco Product Scientific Advisory Committee, (TPSAC), Dose-Response Effects of Spectrum Research Cigarettes (www.ncbi.nlm.nih.gov/pubmed/23178320), summarizes that 22nd Century Group's Spectrum cigarettes "that vary in nicotine content produce an expected dose-response effect." Further, Spectrum cigarettes may represent an opportunity to "scientifically determine if reducing (or increasing) nicotine content in cigarettes may be a viable national policy strategy."

    Indeed, if health awareness and an ever-increasing stranglehold on the number of public places where smoking is permitted aren't enough to lower consumer demand and bolster use of MRTPs, the government is setting initiatives in place through the Tobacco Control Act that could mandate lower levels of nicotine in cigarettes or other related compounds. Regulations of this nature will leave manufacturers reeling to meet compliance requirements and will result in increased pressure by consumers for alternatives to today's conventional cigarettes. In this environment, the holy grail for the industry is modified risk combustible cigarettes.

    The New York-based 22nd Century Group has introduced its own products in the U.S. market, including its RED SUN brand that has relatively high levels of nicotine -- slated for national distribution in 2013 as a super-premium cigarette. The company is also developing consumer-acceptable reduced risk tobacco products and is in late-stage clinical trials with very low nicotine (VLN) cigarettes as a smoking cessation product. What these developments provide for are exponential growth prospects for 22nd Century on both horizontal and vertical planes. While big tobacco seems somewhat paralyzed in trying to make decisions about what direction to move for traditional cigarettes, 22nd Century has held a firm course and developed the technology to modify nicotine levels in tobacco from very low to high. In that respect, the company has no peers as no other company has been able to achieve what they have with either raising or lowering the nicotine levels. This could prove to be invaluable to the industry and smokers - and to shareholders of XXII.

    Further, 22nd Century has supplied its very low nicotine (VLN) cigarettes for a 200-patient clinical trial in London where researchers, in collaboration with Pfizer Inc. (NYSE: PFE), are evaluating Pfizer's Chantix in combination with 22nd Century's VLN cigarettes as an improved smoking cessation therapy. Additional independent Phase II studies are ongoing at the University of Minnesota examining the remarkable benefits of the company's VLN cigarettes.

    22nd Century's technology not only works to reduce nicotine levels in the tobacco plant, but it is also efficient in raising nicotine levels to extremely high levels, a methodology that some experts believe reduces exposure to smoke and tar (the bad stuff) by more efficiently giving the smoker the desired dose of nicotine. Similar to coffee served at Starbucks compared to that of the local diner. Less is required.

    Notwithstanding Bank of America's unintentional snub, 22nd Century Group's unique position in the industry is clear. 22nd Century has ties with the U.S. government that distinguish the company from all others in the tobacco industry. 22nd Century's products are sought after by independent clinical researchers worldwide. According to company news releases, this year 22nd Century began actively pursuing licensing agreements with major pharmaceutical tobacco companies. What's more the company recently announced its intention to file a modified risk tobacco product application with the FDA for two of its products. Given these facts, this under-the-radar company appears ready to shine. A licensing agreement of some nature - either in the biotechnology or tobacco arenas would seem on the horizon and would obviously ignite the stock.

    Apropos, with all of the information on the tobacco industry that is hitting the wires this week, it does not appear that XXII is slipping past the eyes of the investment community. Shares are already commanding a 75 percent premium to the previous Friday's closing price as volume has skyrocketed to record highs. Even with the deserved attention, shares still have plenty of upside potential as they sit a dollar below all-time highs.

    Insiders apparently are seeing the opportunity. Chief Executive Officer, Joseph Pandolfino, and President, Henry Sicignano, have invested more than $300,000 this month purchasing more than one million shares according to company's filings with the Securities and Exchange Commission (secfilings.com/SearchResults.aspx?ticker=XXII). Insiders buying could be equated to "where there's smoke, there's fire" and this company may be ready to (no pun intended), light it up.

    -----------------------

    Disclaimer: Neither otcshowcase.com nor its officers, directors, partners, employees or anyone involved in the publication of the website or newsletters ("us" or "we") is a registered investment adviser or licensed broker-dealer in any jurisdiction whatsoever. Further, we are not qualified to provide any investment advice and we make no recommendation to purchase or sell any securities. The prior article is published as information only for our readers. otcshowcase.com is a third party publisher of news and research. Our site does not make recommendations, but offers information portals to research news, articles, stock lists and recent research. Nothing on our site should be construed as an offer or solicitation to buy or sell products or securities. This site is sometimes compensated by featured companies, news submissions and online advertising. Viper Enterprises, LLC (parent company of OTC Showcase) has received no compensation for this article from and owns no shares of the aforementioned company(ies), but may initiate a position in the next 72 hours. Please read and fully understand our entire disclaimer at www.otcshowcase.com/about-2/disclaimer.

    Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in OTC:XXII over the next 72 hours.

    Nov 29 10:11 AM | Link | Comment!
  • Five Regenerative Medicine Companies Worthy Of Portfolio Addition

    Broadly speaking, regenerative medicine is an innovative new area of medicine that is focused on the development of new therapies that enable healing and repair of the body in ways that overcome the limitations of conventional medical treatments. Regenerative medicine uses a range of approaches, including cell based therapies, stem cells, tissue engineering and others, that represent an exciting alternative to traditional pharmaceuticals and current standards of care that, in many cases, still only treat symptoms - as opposed to addressing the underlying cause of the problem - whether from disease or injury.

    In short, regenerative medicine, as the name implies, seeks to repair, regenerate or replace damaged or diseased tissue that is at the root of the problem, in order to restore function and homeostatic health. It has been a couple of decades in development, but recent advancements in research and growing acceptance in the medical community and among patient groups now position the field of regenerative medicine at a tipping point that could revolutionize medicine across the complete spectrum of indications. In particular, areas where traditional approaches have failed to address unmet needs from inflammatory and autoimmune diseases to neurological injury and disease, to cardiac conditions and back again. In the Ten Commandments of building a diversified portfolio, holding a regenerative medicine company - or two - is a principle of the investing handbook.

    While there are numerous companies advancing interesting regenerative medicine programs, several have emerged as uniquely positioned to have a meaningful impact and build exponential shareholder value in the near term. Each, in their own right, is a standout and contains headroom for market appreciation simply on the merits of what they are already well positioned to accomplish. In this, the first part of a multiple-article exercise, we will examine some of the leaders from an overview perspective to delineate where true value resides. In each case, the companies are dedicated to bringing to market their respective biologics to treat indications with high morbidity and mortality rates or for which current therapies offer little therapeutic option.

    Selecting only a few companies is a daunting task, with outfits such as Biotime, Inc. (NYSE: MKT: BTX), Neostem (NYSE MKT: NBS) and Cytomedix, Inc. (OTCBB: CXMI) presenting unique, early-stage growth propositions, but not making the list. Although a fan favorite of many, Advanced Cell Technology Inc. (OTCBB: ACTC) didn't make the cut because of its relatively high market capitalization compared to peers, large number outstanding shares, and relatively early clinical efforts, while Neuralstem, Inc. (NYSE MKT: CUR) was left-out because of facing stiff challenges in addressing neural indications in the brain and spine.

    Mesoblast Ltd. (ASX: MSB), is clearly positioned as a global leader in regenerative medicine, but was not included because the company trades primarily on the Australia exchange and is already valued far above any peers ($1.7 billion market cap), thereby giving it more limited upside than the companies we have selected.

    A quick synopsis of the five most intriguing portfolio candidates in the regenerative medicine industry (in alphabetical order):

    Aastrom Biosciences, Inc. (NASDAQ: ASTM)(http://www.aastrom.com) - Ann Arbor, Michigan-based Aastrom is focused on cardiovascular disease. The company is currently evaluating its autologous cell therapy approach (i.e. in which cells are isolated from the patient, expanded, and then readministered) in U.S. clinical trials for the treatment of critical limb ischemia, or CLI, (Phase III trial enrolling now) and dilated cardiomyopathy, or DCI, (Phase IIa completed). Critical limb ischemia, the most severe and deadly form of peripheral artery disease, is estimated to affect about 3.5 million patients in the U.S. alone, with the incidence rate expected to nearly double by 2030 due to the aging population and increased prevalence of diabetes. Importantly, CLI is an extremely expensive disease with the inpatient treatments in excess of $55,000 per patient, representing a multi-billion-dollar market opportunity by itself. With the Phase III already in the works and about $28 million in cash, Aastrom is in a solid position.

    Athersys, Inc. (NASDAQ: ATHX)(athersys.com) - Cleveland, Ohio-based Athersys is developing MultiStem, a donor-derived "off-the-shelf" stem cell product that can be manufactured on an industrial scale and is administered like a traditional biotech drug. The company is pursuing development for multiple disease indications, including four different U.S. and/or international clinical trials in the inflammatory & immune, neurological and cardiovascular areas, with a fifth authorized to begin in Germany (for solid organ transplants). In partnership with Pfizer, Inc. (NYSE: PFE), MultiStem is in an ongoing Phase II trial for Inflammatory Bowel Disease, which affects roughly 2.4 million people in the U.S., Europe and Japan. Another active Phase II clinical trial involves MultiStem for ischemic stroke, which represents the leading cause of serious long-term disability, and strikes approximately 15 million people each year globally, including 2 million patients each year in the U.S., Europe and Japan. Other clinical programs include treating complications associated with traditional bone marrow or hematopoietic stem cell transplants, such as Graft Versus Host Disease (GvHD) (the company is planning a Phase II/III study after its recently completed Phase I - and has Orphan Drug designation from FDA); as well as treating damage from heart attack (acute myocardial infarction), where aPhase I has been completed, and the Phase II is authorized by the FDA to start). Athersys, who already had about $10 million in cash and equivalents, recently completed a successful offering that was oversubscribed and added more than $20 million to the company coffers to advance clinical trials. Meanwhile, the company has a modest spend rate, yet more clinical programs than most of its peers, and is pursuing massive markets that tread into tens of billions of dollars annually. Several other factors make Athersys a compelling value, including two orphan drug designations by the FDA; the partnership with Pfizer; multiple analyst coverage with "buy" and "outperform" ratings, and an average price target amongst four leading analysts of $6.50 per share (Thomson Reuters First Call). It's easy to see why the recent offering was oversubscribed with investors.

    Cytori Therapeutics, Inc. (NASDAQ: CYTX)(cytori.com) - Based in San Diego, CA, Cytori is developing therapies based on autologous adipose (fat)-derived stem cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Utilizing adipose-derived stem cells is not an origin point that many companies have focused on, but there are strong possibilities for this method. Cytori is in the midst of several trials throughout Europe and the U.S.: ATHENA, a Phase I/II trial for refractory heart failure in the U.S.; ADVANCE, a Phase II European trial for acute myocardial infarction; PRECISE, which completed a Phase I European trial for chronic myocardial ischemia; and APOLLO, which completed a Phase I European trial for acute myocardial infarction. The company's Phase IV RESTORE 2 trial was recently completed and designed to evaluate the transplantation of ADRC-enriched autologous fat tissue into and around breast deformities. Through its proprietary offerings, including its Celution product line, Cytori makes its treatments available at the point-of-care for physicians and patients. Another relevant component in valuing Cytori is the fact that late in September it was awarded a contract valued up to $106 Million by Biomedical Advanced Research and Development Authority (BARDA) to develop cell therapies for thermal burns combined with radiation injury. With mid and late-stage clinical trials targeting heart attack patients and ischemic conditions, the potential market is large. With $28 million in cash and equivalents, Cytori has plenty of capital to carry-forward with clinical research.

    Osiris Therapeutics Inc. (NASDAQ: OSIR)(www.osiris.com) - Columbia, Maryland-based Osiris currently has two product candidates in clinical trials spanning several indications. Prochymal, an intravenously administered formulation of mesenchymal stem cells, is being evaluated in Phase 3 trials for acute GvHD and Crohn's disease. Prochymal is currently the only stem cell therapy designated by FDA as both an Orphan Drug and Fast Track product, (although this will likely change as competitor programs advance). Prochymal is also being evaluated in Phase 2 clinical trials for the repair of heart tissue following a heart attack, the protection of pancreatic islet cells in patients with type 1 diabetes, and the repair of lung tissue in patients with chronic obstructive pulmonary disease. The company also has Chondrogen in a Phase II clinical trial for arthritis in the knee and Osteocel-XC in Phase I trials for focal bone regeneration. With some similarities to Athersys, Osiris clearly has a pipeline with a robust potential patient population, including a diabetes population of more than 25 million in the U.S. alone. The FDA designations to expedite developments are also a plus in addition to having several pivotal phase 3 trials ongoing. Osiris also has more than $45 million in cash and investments, and recently obtained approval for treating pediatric GVHD in Canada and New Zealand.

    Pluristem Life Sciences Inc. (NASDAQ: PSTI)(www.pluristem.com) - Haifa, Israel-based Pluristem is focused on placenta-based cell therapies. The company's patented PLX (PLacental eXpanded) cells drug delivery platform releases a cocktail of therapeutic proteins in response to a variety of local and systemic inflammatory diseases. Like the Osiris and Athersys product platforms, PLX is an "off-the-shelf" product candidate that requires no tissue matching or immune-suppression treatment prior to administration. With PLX, Pluristem is targeting Peripheral Artery Disease (PAD), neuropathic pain and muscle injuries, with the initial clinical trials designed for PAD. Early clinical trials are complete and a multinational Phase II/III study of PLX-PAD for critical limb ischemia and a Phase II study for intermittent claudication are set to begin under guidance from the FDA and the European Medical Agencies. As mentioned with Aastrom, peripheral artery disease is an expensive disease to treat that has a quickly-growing patient population. Aside from PAD, Pluristem has gone broad with their technology, which, like Athersys, gives it a particular appeal, as all the eggs aren't in one basket. The company has a reasonable amount of cash and marketable securities at its disposal, totaling roughly $39 million.

    A look at the recent share structure and valuations of these companies (as of November 2, 2012):

    With this brief overview, some stark discrepancies immediately surface. For starters, notice how much smaller the market capitalizations are compared to Mesoblast's aforementioned market cap of $1.7 billion. Also the discrepancy of the valuation of Athersys compared with peers is plainly evident and without solid rationale to be so far out of kilter given the company's stout pipeline.

    From a broad perspective, these companies are all basically developmental (i.e. mid to late stage clinical trials) with negligible revenue. Such is the case with most biotechnology stocks regardless of specialty, yet many traditional biotechs command much higher valuations. Even the mighty Mesoblast only generated $38.3 million in revenue during fiscal 2012 while recording a loss before taxes of $48.7 million for the year. To their credit, the company still has $207 million in cash on hand.

    Taking into account pipelines, assets-to-liabilities, partners, stages of clinical development and magnitude of opportunity related to indications, Aastrom, Athersys, Cytori, Osiris and Pluristem possess the largest amount of headroom for near-term share appreciation out of the more than 50 U.S.-listed companies that are focused in the regenerative medicine space.

    Many have proclaimed that regenerative medicine is far from commercialization. In reality, however, there are already regenerative medicine products on the market now, such as Organogenesis Apligraf and Gintuit products, Advanced Biohealing / Shire Regenerative Medicine Dermagraft, treatments for orthopedic repair from Sanofi-Genzyme's Biosurgery division, as well as a few others. Further, many clinical trials are reaching advanced stages, and a few could be shepherded through clinical development in an expeditious manner, as a result of recent FDA initiatives designed to bring innovative products to market faster in areas of serious unmet need. There are certainly regulatory hurdles, but a consistent record of safety and promising signs of effectiveness make it seem like a good bet that at least a few more products will make it onto the market in the reasonably near term. The truth is that the age of regenerative medicine has finally crept upon us and appears ready to gain some steam.

    Big pharma is already jockeying for position that should start to translate into valuation impact for smaller companies. In April, Shire (Nasdaq: SHPGY) acquired the assets of Pervasis to bolster its regenerative medicine division. Terms weren't disclosed, but up to $200 million in potential milestone payments were. In 2011, Shire paid $750 million to acquire Advanced BioHealing to gain access to Dermagraft, a skin substitute that assists in restoring damaged tissue. In February, Baxter International (NYSE: BAX) bought Synovis Life Technologies Inc. for $28 per share, in a deal valued at $325 million to expand "Baxter's regenerative medicine and BioSurgery franchise."

    As major drug makers have not fared well in recent years at developing therapeutics from scratch, it's more than likely that most will follow the path of Shire and Baxter to augment their current regenerative medicine efforts by partnering with, or buying, smaller firms. The potential clinical and market impact of the companies mentioned above, would seem to make them valuable as portfolio additions to funds and individuals, especially as major players seek to re-fuel dwindling pipelines and acquire innovative therapies that can generate billions in annual sales. Companies like Johnson & Johnson (NYSE: JNJ) by itself or through its Advanced Technologies & Regenerative Medicine, LLC division, are "keeping an eye out for new technology," according to Jay Siegel, CBO at JNJ. If they are, investors should be as well.

    Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in ATHX over the next 72 hours.

    Nov 08 5:22 AM | Link | Comment!
  • Breast Cancer News: Geron Drug Fails, Herceptin May Increase Heart Problems, Sunshine Biopharma Heading For Clinical Trials

    Nobody said developing a new cancer drug was easy. Geron Corp. (NASDAQ: GERN) shares took a nosedive last Monday, falling more than 50 percent as the drug maker disclosed that it is discontinuing a randomized Phase II clinical trial of its anti-cancer drug Imetelstat in metastatic HER2-negative breast cancer patients. Menlo Park, California-based Geron said that the median progression-free survival in the Imetelstat arm was shorter than in the comparator arm in the trial. Imetelstat was being evaluated in combination with paclitaxel, compared to paclitaxel alone.

    Worse yet, Geron said that things aren't looking good for Imetelstat hitting its primary endpoint in a study against non-small cell lung cancer (NSCLC) either, although the Phase II trial will still continue. An interim analysis of the study suggests only a modest trend of efficacy in favor of the Imetelstat arm as compared to controls. The outlook at this point is not bright for advancement of Imetelstat to the pivotal third stage of clinical trials against NSCLC.

    The news also had a collateral negative effect because Geron had abandoned its leadership position in stem cell research to focus on cancer studies less than one year ago.

    The silver lining for Geron shareholders is that Imetelstat still has potential. It is also under evaluation in two hematologic malignancies: multiple myeloma and essential thrombocythemia. The company anticipates releasing top-line results from these studies in the fourth quarter of this year. Geron also has GRN1005 which is currently in phase II studies for brain metastases arising from non-small cell lung cancer and breast cancer. Interim data from the GRN1005 breast cancer trial is expected in early December. Positive data there could provide resurgence in share value.

    It is also noteworthy that the company - which is now valued at $174.5 million after the Monday plunge - still has $122 million in cash and investments on hand as of the end of the second quarter. This certainly can wend way for speculation that the firm is now undervalued with its drugs still in development.

    Also in the news recently was a new study by the Group Health Research Institute in Seattle which determined that Herceptin® (trastuzumab), the monoclonal antibody that interferes with the HER2/neu receptor from Swiss drug maker Roche Holding AG (OTCQX: RHHBY), increases the risks for heart problems in breast cancer patients significantly more than originally thought. Used either alone or in combination with chemotherapy, Herceptin® is one of the most widely used drugs in the world to combat breast cancer.

    Roche, the world's biggest cancer drug manufacturer, relies heavily on Herceptin® as its third largest drug in sales annually. Herceptin® sales tallied $5.5 billion last year. Sales in the first half of 2012 have risen to about $3 billion. The big biotech is expecting results from 19 clinical trials in the next 18 months to offset any potential decrease in sales of Herceptin® as it faces its latest hurdle and patent expiration in 2014. Twelve of its 19 late-stage trials involve new drugs for a variety of indications.

    In November 2011, the FDA revoked the approval of Roche's Avastin® (bevacizumab) as a treatment for breast cancer, but it still retained its indications for colon, kidney, lung and brain cancer.

    Erin Aiello Bowles, an epidemiologist at the Group Health Research Institute and lead author of the study published in the Journal of the National Cancer Institute, explained that the data collected in clinical trials excluded many women that receive the treatment in the real world. The women, generally older or with a pre-existing conditions, were not allowed to be part of the clinical trials.

    Bowles' study, which examined 12,500 women diagnosed with breast cancer, found that the overall risks of developing heart failure or cardiomyopathy when trastuzumab was taken alone are greater than chemotherapy alone. As a combination therapy with chemo, the risks proved to be even greater than trastuzumab as a stand-alone treatment.

    "These drugs are toxic. They kill cancer cells, and sometimes kill other cells in the body, too," commented Bowles. Not discounting the efficacy, though, Bowles continued, "These drugs are still important for women with breast cancer to use because we know they improve survival. But as with any drug, people need to be aware of the risks, too."

    Bowles also explained that the risks were also correlated to age, with elderly patients experiencing a greater likelihood of serious heart complications.

    Education could also be a driving force to help fight subsequent long-term side effects. According to the American Cancer Society estimates, there are more than 12 million cancer survivors alive in the United States. The problem lies in secondary battles with life-threatening effects from cancer treatments. Recent data from a June meeting at The American Society of Clinical Oncology showed that 94 percent of primary care doctors are unaware of the potential long-term effects of commonly used drugs to treat breast and prostate cancer.

    Geron and Roche have been focused on HER2 (human epidermal growth factor receptor 2). The HER2 gene makes HER2 proteins, receptors on breast cells that normally help control how a healthy breast cell grows, divides, and repairs itself. But in about 25 percent of breast cancers, the HER2 gene is dysfunctional and makes too many copies of itself which leads to breast cells growing and dividing in an uncontrollable fashion.

    The other gene commonly associated with aggressive forms of breast cancer is TOP2 (Topoisomerase II). TOP2 enzymes are critical in transcription, replication and chromosome segregation which has made them a topic for anti-cancer drugs, but the pathway has been somewhat elusive to date. TOP2 is also an important target for many other cancer lines in addition to breast cancer, including prostate, colon, lung, stomach and ovarian. Currently, the drug of choice targeting TOP2 in cancer patients is etoposide; marketed as Etomedac®/Eposin by Medac and by Bristol Meyer Squibb (NYSE: BMY) as Etopophos® and Vepesid®.

    Looking to move down the regulatory pathway focused on TOP2 in breast cancer patients is Sunshine Biopharma (OTCBB: SBFM) with its Adva-27a drug candidate. Published laboratory data show that Adva-27a is a true TOP2 inhibitor and is significantly more effective at killing multidrug-resistant breast cancer cells (MCF-7/MDR) and small-cell lung cancer cells (H69AR) than etoposide.

    Sunshine has taken delivery from the Contract Manufacturing Organization (NYSE:CMO) and is now conducting a series of requisite biological tests to ensure that the newly manufactured batch is identical to the original, not only in terms of chemical structure but also in terms of biological activity. The company plans to initiate Phase I clinical trials for Adva-27a in 2013 at the Jewish General Hospital, Montreal, Canada, one of McGill University's Hospital Centers.

    The American Cancer Society estimates that in the United States there will be about 230,000 new cases of breast cancer diagnosed in 2012 and about 40,000 deaths from the disease. Roche's Herceptin® may be facing some obstacles in the near term and the patent cliff in 2014, but sales have been steadily increasing since its 2006 FDA approval. Notably, the drug only targets about 15 to 20 percent of breast cancer patients. Gauging potential market value for Sunshine's Adva-27a from Roche's sales of Herceptin, it is discernible that its market capture could be far greater being that the TOP2-positive breast cancer patient population is much larger.

    ---------------

    Disclaimer: Neither otcshowcase.com nor its officers, directors, partners, employees or anyone involved in the publication of the website or newsletters ("us" or "we") is a registered investment adviser or licensed broker-dealer in any jurisdiction whatsoever. Further, we are not qualified to provide any investment advice and we make no recommendation to purchase or sell any securities. The prior article is published as information only for our readers. otcshowcase.com is a third party publisher of news and research. Our site does not make recommendations, but offers information portals to research news, articles, stock lists and recent research. Nothing on our site should be construed as an offer or solicitation to buy or sell products or securities. This site is sometimes compensated by featured companies, news submissions and online advertising. Viper Enterprises, LLC (parent company of OTC Showcase) has received no compensation for this article from and owns no shares of the aforementioned company(ies). Please read and fully understand our entire disclaimer at http://www.otcshowcase.com/about-2/disclaimer.

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

    Sep 20 2:55 PM | Link | Comment!
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