Author's Note (Feb. 4, 2013): Due to Dr. Paul Ladenson's appointment as Director of Endocrinology and Metabolism at Johns Hopkins, I made the assumption that Johns Hopkins was therefore associated at the institutional level in Star Scientific's ASAP Thyroid clinical trial. It has now become clear that while Dr. Ladenson is the head clinical consultant to Star for the ASAP trial, the relationship between Dr. Ladenson and Star Scientific does not extend to Johns Hopkins as an institution. I regret any confusion, and I am pleased to correct this error below.
Massive Risk Reduction
Last Monday's press release regarding the proof of concept and efficacy of anatabine as employed in human thyroiditis trials by Rock Creek Pharmaceuticals in conjunction with Dr. Paul Ladenson, who acts as a key clinical consultant for Star, clarifies to a large degree the science risks of Star Scientific's (STSI) over-the-counter compound Anatabloc. Because of the $20 million money raise in October, the company's cash now totals about $30 million and its burn rate has been recently cut roughly in half. The science and financial risk potential has now been all but muted.
Risk #1 - The New Data from Human Trials
The Science in Crescendo
a. A steady increase in intensity or force
b. The climactic point or moment after such a progression
Dr. Paul Ladenson is the lead clinical consultant for the so-called ASAP* trial. The ASAP (Anatabloc Supplementation Autoimmune Prevention) Human Thyroid Study (in nine locations) analyzes the impact of anatabine dietary supplementation on thyroid health. The ASAP thyroid study was planned as a human follow-up of a successful animal study, "Anatabine Ameliorates Experimental Autoimmune Thyroiditis, Endocrinology. 2012 September. Dr. Ladendon said:
Data from this rigorously conducted, placebo-controlled, double blind trial show that anatabine-treated subjects had progressive decreases in circulating thyroglobulin antibody levels, which became significant by the end of the trial.
[Initial results for all study subjects suggest that dietary supplementation with anatabine ameliorates the immune system's targeting of the thyroid gland in autoimmune thyroiditis.]
Dr. Ladenson has previously stated that:
Aside from RCP-006 [anatabine - now known as Anatabloc] there is no known compound that stops thyroiditis.
Risk #2 - Efficacy and Proof of Concept
Prior to Monday's press regarding the successful Rock Creek / Johns Hopkins human trials of anatabine there was always the possibility that the Star compound would not be effective in humans even though there are numerous corroborating animal studies and extensive anecdotal personal testimonials to that effect. That concern is now off the table. We now KNOW that anatabine works, and it has worked on all study subjects. To be sure, the human study results have yet to be peer-reviewed, but that will come. Next will be the submissions to the New England Journal of Medicine, Journal of Clinical Endocrinology and the European Journal of Pharmacology, etc... With Dr. Ladenson tendering of the human study/data result, peer review acceptance, review and publication in an important journal, should follow in due course.
Risk #3 - Money
Last October, several of Star's major shareholders converted 18.5 million warrants at $1.00 a share and 1.0 million warrants at $1.50 a share. The new shares brought the total shares outstanding from 146.3 million to the current 165.8 million and Star's cash, from what was previously about $10 million, to almost $30 million. There remain another 16.5 million warrants and 17.7 million options, which, when exercised, would bring Star's current 165.8 million shares to about 200 million shares. The additional 34.2 million shares would add another $78 million of new cash and would bring the cash to near $100 million and help with marketing, promotion, advertising on a much greater scale. Even using the $30 million number, cash should be sufficient to get Star comfortably into 2014 when the company should be cash flow positive, as its burn rate has recently been cut approximately in half. Star's current market-cap is $435 million.
The Quantum Leap & Where We Are Now
So the science has now advanced, demonstrating proof of concept and efficacy in human subjects in trials orchestrated and supervised by Dr. Ladenson, as senior endocrinological consultant for the study.
The totality of this newly reported research on human subjects with active autoimmune thyroid inflammation demonstrates the ability of anatabine to throttle back only the harmful immune system components of inflammation without destructive immune system suppression. This is a quantum leap forward and a breakthrough of historic proportions in the treatment of inflammatory auto-immune thyroid conditions.
Importantly, autoimmune diseases of the thyroid are but one of a near one hundred autoimmune conditions where current treatment consists of treating the symptoms rather than the illness itself. The potential for further anatabine studies on these conditions is near absolute. And because anatabine has been found to be safe, one can expect that many people who suffer from these conditions, and they are in the multimillions, will avail themselves of anatabine / Anatabloc.
Star Scientific currently has three active clinical trials on human subjects evaluating the safety and efficacy of Anatabloc on medical conditions driven by inflammatory components. The studies, being conducted in collaboration with both Rock Creek Pharmaceuticals and the Roskamp Institute, include trials on Alzheimer's disease, autoimmune thyroiditis (Hashimoto's disease), and generalized systemic inflammation.
In a series of press releases in October, 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 (CRP) levels in human subjects with elevated CRP levels. 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 levels in a large percentage of the study population after only one month of dosing at the 1 mg dose, a very low dosage. 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 an enormous number of drug candidates fail for safety concerns, e.g. Vioxx. One advantage of anatabine is that it is a natural component of common foods.
CRP is an important biomarker for inflammation and autoimmune conditions, and its elevation 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.
And finally, referencing the provisional patent application WO 2011/119722 A2 discloses that "S- (-) - anatabine positively correlates with reduction of the inflammatory activity."