GLEN ALLEN, Va., Jan. 28, 2013 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ: STSI) commented today on a January 23, 2013, column appearing on TheStreet.com. That piece contains numerous false and misleading statements regarding the Company's anatabine research and the initial results of the ASAP Human Thyroid Health Study released by Star Scientific on January 7, 2013.
As reported in the Company's January 7, 2013, press release: "The preliminary examination of the primary outcomes shows a clear and statistically significant difference in the treated group as compared to the placebo group by the end of the trial, with declines in anti-thyroglobulin antibody levels. Anatabine subjects also tended toward a reduction in thyroid gland vascularity on ultrasound relative to placebo."
The ASAP study, which examines the impact of anatabine dietary supplementation on thyroid health, was conducted by Rock Creek Pharmaceuticals, the Company's subsidiary. The study was not sponsored by the Johns Hopkins School of Medicine, and the Company never reported otherwise. Indeed, when Star Scientific first announced IRB approval of this study on February 9, 2012, it noted that the study was being conducted by Rock Creek Pharmaceuticals at sites in Texas, Illinois, and Florida. The Company also consistently referenced that this study was being conducted by Rock Creek Pharmaceuticals at multiple sites in subsequent press releases, including the January 7, 2013, release. Any implication by the author of the article in TheStreet.com that Star Scientific stated otherwise is patently false.The statement that there is no science backing that anatabine reduces inflammation similarly is completely false. Since 2011, Rock Creek Pharmaceuticals and researchers at the Roskamp Institute have completed and reported on a number of studies designed to assess the ability of the Company's anatabine compound to lower chronic inflammation in a variety of pre-clinical (non-human) and clinical (human) settings. One study conducted by the Roskamp Institute and reported in The Journal of European Pharmacology in 2011 showed that anatabine lowered levels of amyloid production both in the test tube and when administered to mice vulnerable to accumulation of amyloid which, at excessive levels damages brain tissue. A second manuscript written by the same researchers and published online in The Journal of European Pharmacology in 2012 and in manuscript form in January 2013 further characterized the anti-inflammatory effects of anatabine in several types of animal tissues, in human cells, and in human whole blood. The Roskamp Institute also presented results of pre-clinical studies of anatabine in mouse models of multiple sclerosis, traumatic brain injury, and Alzheimer's disease at the Neuroscience 2012 conference held in New Orleans in October 2012. In January 2012, Rock Creek Pharmaceuticals reported research on the first clinical trial demonstrating that Anatabloc ® lowers chronic inflammation measured by CRP levels in the blood. The reported results were obtained in connection with an in-house study undertaken by Rock Creek that involved a group of smokers who had been using Anatabloc ® on an extended basis. In October 2012, Rock Creek reported on an interim look at the CRP results in a study sponsored by the Roskamp Institute and designed to assess the safety, tolerability, dosing, and biological effects of anatabine citrate. Currently, a clinical study of individuals with mild to moderate Alzheimer's disease is being sponsored by Rock Creek Pharmaceuticals and conducted at the Roskamp Institute. Prior to the introduction of the Company's first dietary supplement, research scientists at Harvard University's McLean Hospital completed extensive research, which was funded by Rock Creek Pharmaceuticals, relating to the safety of anatabine as well as its non-nicotinic effects in connection with development of the product. Furthermore, The Street.com article's implication or suggestion that Johns Hopkins has had no involvement in anatabine research is also false. As previously reported, a preclinical investigator-initiated and independently funded study from Johns Hopkins examined the effect of anatabine supplementation on autoimmune thyroiditis in a mouse model and that research was recently published in an article entitled, "Anatabine Ameliorates Experimental Autoimmune Thyroiditis" in the Endocrine Society's journal, Endocrinology. (Endocrinology. 2012 Sep; 153(9):4580-7.) All three of the published articles referenced in this press release were peer reviewed anonymously by experts in the field chosen by the editors of the journals. Star Scientific notes that the author of the article in TheStreet.com, Adam Feuerstein, has published a number of negative articles regarding the Company and its research on anatabine. The Company believes that investors and consumers of its Anatabloc® product would be well advised to view any such articles by this author or publications regarding the Company in TheStreet.com with substantial skepticism, given the misstatements and misinformation that the author disseminates. Star Scientific takes its responsibilities to provide and present accurate information about and to respond to false statements about its products very seriously. This press release and communications that are being sent to The Street and its author by Star Scientific's attorneys are examples of that effort.