Successful Human Trials Of Star Scientific's Anatabloc Clarifies Risk And Could Drive Share Price
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
cres·cen·do
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.
