Please Note: Blog posts are not selected, edited or screened by Seeking Alpha editors.

Star Scientific - The Science In Ascendancy - Update On The ‘Corrected' Human Study Results

|Includes: Rock Creek Pharmaceuticals, Inc. (RCPI)

Dr. John L. Faessel


Commentary and Insights

Update on the 'Corrected' Human Study results

The Science in Ascendancy

Star Scientific (STSI)

Let's update the evolving anatabine science as recently published exceptional human study results will have significant bearing on Star Scientific going forward. Anatabine is the active ingredient in Anatabloc™.

Star Scientific, in collaboration with both the Johns Hopkins University School of Medicine and the Roskamp Institute, currently has three active clinical trials in humans subjects evaluating the safety and efficacy of Anatabloc in medical conditions driven by inflammatory components: Alzheimer's disease, autoimmune thyroiditis (Hashimoto's disease), and generalized systemic inflammation.

These three human studies are registered with the US FDA and the details may be seen at the FDA website

using the clinical trial ID numbers:

NCT01607619 link here

NCT01551498 link here

NCT01669876 link here

In a series of recent press releases, Star Scientific announced interim results from one of their anatabine clinical trials, the FLINT study (NCT01607619). This study was designed to measure the reduction of C - reactive protein (NYSE:CRP) levels in human subjects with elevated CRP levels. CRP is an important biomarker for inflammation and autoimmune conditions, and is associated with many debilitating diseases such as rheumatoid arthritis, autoimmune thyroiditis, ulcerative colitis, Crohn's disease, Lupus, multiple sclerosis, and many others. For a more comprehensive list see here.

An independent committee from The Roskamp Institute found that Anatabloc was safe and well tolerated, but more importantly that the drug effected a decrease in C-Reactive Protein (CRP) levels in a large percentage of the study population after only one month of dosing at the 1 mg dose. Especially striking was the effect among diabetic patients, where a drop in CRP levels was observed in 61% of the participants.

The word "safe" is important because a huge number of drug candidates fail for safety concerns (e.g. Vioxx, etc). One advantage of anatabine is that, as a natural component of common foods, Star can skip the time and expense of early safety trials and go right to the important stuff - does it work.

The results of study are extremely significant as elevated CRP levels have a strong clinical correlation to the onset and progression of diabetes, and studies have been published in top medical journals documenting this effect, including, and in addition:

The Journal of the American Medical Society, link here.

The Journal of Clinical Endocrinology and Metabolism, link here.

Considering the well-established link between elevated CRP and a panoply of debilitating diseases, these interim results suggest that Anatabloc may be useful the prevention and treatment of many common inflammatory conditions.

Overall, the results from the Star Scientific FLINT study are extremely significant, and the progress of this and other Anatabloc trials will no doubt be closely watched by the medical and scientific community.

Important for investors in Star shares is that these exceptional results will allow a whole 'new' group of institutional investors who previously were not able to invest in companies that did not have successful human trial to do so.

Additionally, the successful human studies will bring new analysis from the investment banking community and other writers and analysts who comment on companies and markets. (I'm thinking for example of John Mauldin who introduced the Star Scientific 'story' to Patrick Cox - Mauldin has over one million subscribers)

Perhaps even more relevant going forward is that successful human trials will open the door for Star, who is working with McColl Partners LLC on "structuring a controlled auction for bidding by pharmaceutical companies, for licensing and/or co-venturing relationships."

McColl Partners is an independent investment banking firm co-founded by Hugh McColl, former Chairman of Bank of America (NYSE:BAC).

It is well known in the scientific community that many Big Pharmas are eagerly pursuing research on both anabasine (the analog of anatabine) and alpha-7 nicotinic receptor agonists, (which is what anatabine is.) Because of the huge market potential companies such as Pfizer, Abbott, Novartis, Lilly, Roche, etc are in the hunt. A small-cap like (STSI) with an effective and safe agent / drug / compound could be a buyout target with possible bidding war evolving.

The companies I mentioned above all have published papers or initiated clinical trials for alpha-7 agonists. For more detail on alpha-7 agonists from the National Institutes of Health > National Library of Medicine link here.

If you would like me to forward two of the OPEN ACCESS documents in pdf form (extremely heady and very technical) from The Journal of Medical Chemistry and The Open Medicinal Chemistry Journal that address these issues and in fact name the Big Pharma companies and the thrust of their research please send me an email here.

I am sure that with the recent new ground being broken because of the successful human trials (of what could be novel treatments for type-2 diabetes and thyroiditis) we can expect additional research to follow from others in the scientific and medical community plus major media coverage. From my enquiries re the new results with endocrinologists and bio scientists from Big Pharma there is a building interest in the anatabine story. One endocrinologist suggested that the study's dramatic results could change the way type 2 diabetes's is treated "straightaway", especially in that there are little if any side effects from the compound. All who hear the story wants to know more…

Re the Johns Hopkins thyroid study on humans

The Star press release of October 24th said that the company anticipates completion by the statistical team in December 2012.

The key quotes:

1. "The research, which has moved from analyzing animals to analyzing humans, was designed to see if any of the changes observed in the mice could be observed in subjects with autoimmune thyroiditis. A per protocol, scheduled, blinded (Treatment A versus Treatment B) interim look was recently completed, with data available for approximately 48 of the 165 randomized subjects at the time of the interim look."

2. "The raters who reviewed the data agreed that there were sufficiently large enough intertreatment differences, in both anti-thyroid antibody and interleukins, that the study was likely to reach its designed objectives. The statistical team that conducted the interim look recommended continuing the study as planned, and the company anticipates completion and data base lock in December 2012."

While we know in the hierarchy of scientific investigations that animal studies do not carry the weight of human studies there is an approximate 80% correlation. Interesting for example is that 99% of mouse genes have an equivalent in humans making mice ideal for studying. (Look below for a fascinating story of how Alexander Fleming, Ernest Chain and Howard Florey used mice to discover the workings of penicillin.)*

We know from the above mentioned Johns Hopkins animal studies that;

"Anatabine ameliorates disease in a model of autoimmune thyroiditis, making the delineation of its mechanisms of action and potential clinical utility worthwhile."(More detail on the mice studies below.)**

Now, the new human data from the Johns Hopkins thyroid study (funded by a grant from the Walton Family Foundation), demonstrates that the treated and untreated test subjects show significant differences. In addition, as in the animal studies the interleukins associated with thyroiditis are seemingly reduced.

While we have to wait until December to see the Johns Hopkins human thyroiditis results, in my opinion they will be similar to those of the already completed study on mice that showed reversal of thyroid disease. 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."

* In 1928, Alexander Fleming noticed that staphylococcus bacilli would not grow on a culture medium accidentally contaminated with a mold, Pencillim notatum. But test tube experiments failed to show the antibiotic properties he expected. Ten years later, Oxford chemists Ernest Chain and Howard Florey were working on antibacterial substances. Penicillin wasn't a top priority. But when Chain injected two mice with it, they remained healthy. Delighted by this apparent lack of toxicity, Florey then decided to give his full attention to penicillin. Only by 1940 was enough penicillin available for testing. Eight mice were infected with a deadly dose of 110 million streptococci bacteria. One hour later, four of them were injected with penicillin. These survived but the untreated ones died. Florey said, "It looks like a miracle". Indeed it was…

** 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 teams animal studies 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.

If you missed any of my previous reports more specific in detail and scope to each of Star's themes please send me an email here.

Disclaimer; I bought shares of Star Scientific in the open market and have no relationship with the company.