New Peer Review Credibility From Johns Hopkins Could Drive Star Scientific Shares Higher

Jul.25.12 | About: Rock Creek (RCPI)

Hypothesis no longer: Johns Hopkins scientists now believe they know why Star Scientific's (CIGX) anatabine compound Anatabloc works. Newly presented thyroid research from the peer reviewed journal Endocrinology makes the case. The implications could drive shares sharply higher as peer reviewed substantiation brings new heights of credibility to the science. See below for context and amplification.

This is important breakthrough news from Johns Hopkins University School of Medicine (where the thyroid research and studies have been funded by a grant from the Walton Family Foundation), so slip on your science hat and stay with me on this. The implications from the medical community will now carry new weight as they will be able to officially discern the kind of conditions that anatabine/Anatabloc could be effective in treating.

Autoimmune (so-called "Hashimoto") thyroiditis, first reported in 1912 and considered a rarity until the mid-1950s, has now become the most common of over 100 autoimmune diseases. The list is available here. A Google search of thyroid disease brought up 7,500,000 results.

What is especially interesting is that these autoimmune conditions are precisely those Anatabloc seems to benefit. The multitude of users of Anatabloc already know that it works - so now it becomes "official." Get the picture? Read on.

I have been following and writing about CIGX for over two years, and the shares have gone up over this time frame from just over $1.00 to Friday's close of $4.05 (the shares traded above $5.00 last year and more recently in early July). Obviously the stock has been a big winner, and the science supporting the story has developed to ever more established heights of the 'nigh astonishing': it has progressed from the genesis of discovery to testing, to peer review, to more testing and now to explanation in the leading journal Endocrinology as to "why" it's believed to work.

Human studies remain to be announced; however, Star has said in this regard: "The current impressive results achieved by the Johns Hopkins team strongly support the first look at the thyroid data in man, which we anticipate will be available in the third quarter."

It should be noted that nonbelievers are plentiful regarding the shares of CIGX, as there is a big short interest of 23,622,933 shares, a large percentage of which has been around for well over two years. The number of shares short is up 1,789,378 shares from the last reporting period of two weeks prior. My comment is that much has changed over the last year with the above mentioned impressive news related to anatabine / Anatabloc and it's now a whole new ball game. Shorts should be worried as the remarkable science continues to advance.

Last Tuesday, July 17, in the freshly released Endocrine Society journal Endocrinology, a peer reviewed research abstract was published by the Department of Pathology, Divisions of Endocrinology and Metabolism, Department of Medicine, Johns Hopkins University School of Medicine, and the Feinstone Department of Molecular Microbiology and Immunology (P.C.) of the Johns Hopkins Bloomberg School of Public Health.

The Endocrine Society is the world's oldest (founded in 1916), largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology.

It can be stated that the aforementioned institutions, their leading scientists, and one of the world's leading medical journals (and throw in the funding by the Walton Foundation) didn't, as my dad use to say, "just fall off a turnip truck."

As most followers of CIGX know, significant and ongoing research is underway in nine clinical sites in Michigan, Texas, New Jersey, Illinois, and Florida, referred to as the Anatabloc Supplementation Autoimmune Prevention thyroid study. Human study results are due in Q3, as mentioned above.

Another study in Pisa, Italy (500 thyroid patient participants), is orchestrated by Johns Hopkins scientists as well at the University of Pisa Medical School. Extraordinary is that the University of Pisa (founded in 1343) is where Galileo, often called the "father of science," attended and later taught.

Briefly, the just released research abstract gives a brief history of the several studies that have shown:

  • that smoking (think anatabine / Anatabloc) has also been associated with a few apparent "salutary" (beneficial) actions;
  • what's in tobacco - over 4,000 components;
  • that nicotine is known to possess anti-inflammatory properties;
  • how nicotine affects the central nervous system and (more recently described) the immune system;
  • validation of the human observations with mice studies;
  • the detail of how the research was conducted in terms of dosage levels, body weight, etc.;
  • the histopathology (post-mortem) outcome;
  • the assessment of results.

It is here that we delve into the all-important but deeply misty genetic / cellular jargon of the molecular biologist that I will try, in brief, to make understood.

Rather than forcing some correlated statistical analysis of multiple linear regressions with generalized estimating equations into your hopefully pleasant daily routine, know that key genes IL-1, IL-R2, and IL-18 were quieted and restored to normal, and this may explain the amelioration of thyroiditis incidence.

The Johns Hopkins team found that anatabine profoundly reduced the incidence of thyroiditis in the mice; nearly 100% of the untreated mice developed disease while only 62% of the anatabine-treated mice were found to have developed thyroid disease. Furthermore, in the mice that did develop disease, the severity of the disease was markedly reduced relative to the animals that did not receive anatabine. In fact, the mice that received no anatabine developed thyroiditis that was four times more severe than the mice that were treated with anatabine, as indicated by a thyroiditis severity ranking of 0.5 versus 2.0. These results demonstrate that anatabine was able to completely prevent the disease in many mice and significantly reduce the severity of disease in the entire population that received the treatment.

In addition, and key to finding the "why" of anatabine's mechanistic effect, the Ladenson team analyzed numerous important biomarkers of inflammation in the mice. They found that the treatment with anatabine significantly reduced the presence of numerous proinflammatory agents such as interluken-1 receptors, interluken-18, COX2, and others. These findings indicate that anatabine acts far enough upstream in the biochemical pathway to effect an orchestrated and broad-based response to inflammatory disease such as thyroiditis.

Overall, the findings of the Johns Hopkins team are important in that they not only demonstrate the potential efficacy of anatabine in treating Hashimoto's disease, but they also begin to make clear the mechanistic underpinnings of how anatabine works and suggest that this compound may be useful to treat other autoimmune and inflammatory diseases beyond thyroiditis.

Indeed there's something in the tobacco plant that's good for you...

If you would like a full copy (in pdf format) of the Johns Hopkins abstract, "Anatabine Ameliorates Experimental Autoimmune Thyroiditis" (containing colored slides / graphs and electron microscopy of the genes) from the journal Endocrinology, please email me your request and I'll shoot it to you... Dr.Faessel@onthemar.com

Of particular note: At a meeting at the Roskamp Institute which I attended in June 2011, Dr. Paul Ladenson, Director of the Division of Endocrinology at Johns Hopkins stated that, "aside from RCP-006 (anatabine - now known as Anatabloc) there is no known compound that stops thyroiditis."

A Google search of "thyroid symptoms" brought up 19,600,000 results.

Also of note: During a Q & A at a large scientific meeting on October 27, 2011 in Newport Beach CA, Dr. Ladenson was asked pointedly by a Big Pharma senior scientist who I know well (Ph.D. biochemist), "What is the mechanism of the action?" (i.e. "why" it works). Ladenson responded, "They didn't know yet." Now they believe they know. Dr. Ladenson is one of the Johns Hopkins scientists who authored the study.

Johns Hopkins University endocrinologist Paul Ladenson had conducted studies in 2004 among a group of flight attendants and found reduction of thyroiditis / Hashimoto's disease related to inhalation of second hand cigarette smoke. The data showed a reduction of the disease, although the study (which showed smoking could be good for you) was 'put aside' because of the many ills of tobacco. However, once alerted to the new Roskamp studies, Johns Hopkins scientists began new research on the anatabine compound.

Over and above the aberrant autoimmune conditions Star states in their patent application (International Publication Number - WO 2011/119722 A2) that anatabine / Anatabloc positively correlates with reduction of inflammatory activity associated in 100's of other conditions, including both cardiovascular disease and cancer.

Striking is that page 11 of the patent application mentions 130 different types of cancer that may be addressed with anatabine. In addition "anatabine can be administered to reduce and/or reverse cellular senescence (aging)."

Another more recent use for anatabine / Anatabloc is for the general aches and pains resulting from exercise and just plain old wear and tear. Many pro athletes are now taking it to reduce inflammation and from what I hear word is spreading like mad about its benefits. A few months ago pro golfer Fred Couples became an Anatabloc spokesperson. Prominently, Anatabloc is an over the counter anti-inflammatory product, has none of the deleterious steroidal side effects, nor is it a forbidden, pharmacologically active "doping" anti-inflammatory substance banned by the sports authorities.

In conclusion, consider this question: With this just published Johns Hopkins abstract delineating in scientific terms the mechanism of action (and results), would you envision the Johns Hopkins-orchestrated thyroid studies in Pisa, Italy, and the 9 studies in the USA (results due shortly) to be anything but positive?

Another item in closing: Eight years ago I was diagnosed with hypothyroidism and have been treated for the disease since then. I just received my lab results back from my internist. My Thyroid Stimulating Hormone test was 1.84, the lowest reading in 8 years and down from 6.29 (hypothyroidism) when I began my treatment. Since I began taking Anatabloc last year my TSH has fallen from 3.3 to the new low of 1.84.

Disclosure: I am long CIGX. I have bought shares the open market and have no affiliation with the company.