GLEN ALLEN, Va., Oct. 31, 2013 /PRNewswire/ -- Star Scientific,
Inc. (NASDAQ: STSI) and Rock Creek Pharmaceuticals, Inc. announce
the publication of a peer-reviewed article reporting results from
the Company's ASAP (Anatabloc® Supplementation Autoimmune
Prevention) clinical trial in patients with Hashimoto's
thyroiditis. The article, entitled, "Anatabine supplementation
decreases thyroglobulin antibodies in patients with chronic
lymphocytic autoimmune (Hashimoto's) thyroiditis: A
randomized controlled clinical trial", was published October 31, 2013 as a Brief Report in The
Journal of Clinical Endocrinology & Metabolism
(JCEM). JCEM is a publication of The Endocrine
Society, and is described on their website as, "the world's leading
peer-reviewed journal for clinical research and practice reviews in
endocrinology."
(Logo:
http://photos.prnewswire.com/prnh/20130319/PH79245LOGO )
The ASAP study was a three-month, IRB-approved, five-visit,
double-blind, randomized, placebo-controlled, multi-site study
evaluating the impact of anatabine dietary supplementation in
patients with Hashimoto's thyroiditis, one of the most common
autoimmune diseases and a frequent cause of thyroid
dysfunction. A total of 146 patients, 70 receiving anatabine
and 76 placebo, completed the study at nine sites in the United States. Anatabine lozenges (9-24 mg
per day based upon body weight) or placebo, each containing
vitamins A and D3, were administered orally, three times a day for
three months, with patients returning at four-week intervals for
laboratory testing and/or ultrasonography of the thyroid.
The primary outcomes tested whether dietary supplementation with
anatabine ameliorates the immune system's targeting of the thyroid
gland in cases of autoimmune thyroiditis. The results showed
that anatabine reduced the patients' immune reaction against their
own thyroid gland. Patients taking anatabine had a
significantly greater reduction from baseline in serum
thyroglobulin antibody levels compared to patients on placebo (p=
0.027). Similarly, more patients in the anatabine group had a
greater than 20% drop in thyroglobulin antibodies than patients on
placebo (p=0.023). Finally, the percentage of patients on
anatabine with reductions in thyroglobulin antibodies of at least
25, 50, 75, or 100 WHO units was significantly greater than that of
patients on placebo (all p < 0.05 at all cut-off levels). There
were no significant changes or treatment group differences in serum
thyroid function tests, thyroperoxidase antibody, inflammatory
biomarkers, or ultrasonography measures.
Overall, as the study concludes, the anatabine supplement was
safe and well tolerated, although it was associated with more minor
adverse events on initial dose adjustment. The most common
MedDRA adverse events upon starting anatabine supplementation were
mild dizziness (36%), nausea (8%), headaches (7%), and paresthesia
(7%); most of the events were resolved with simple dose adjustment.
Very few patients withdrew from the study due to adverse events (7
on anatabine and 1 on placebo). There were no significant
abnormalities in clinical laboratory values attributed to
anatabine, and no clinically significant effects of
supplementation, either with anatabine or placebo, on vital sign
measures.
Curtis Wright, MD, MPH, Medical
Director of Rock Creek Pharmaceuticals, commented, "The concept for
this clinical trial originated after receiving reports from
individuals that the addition of anatabine, a Solanaceous alkaloid,
to their diet improved their thyroid inflammatory disease.
The idea was supported by multiple recent epidemiological studies
showing that exposure to Solanaceous alkaloids or other compounds
from tobacco, had 'beneficial effects' in Hashimoto's
thyroiditis. Finally, an experimental study in mice reported
that anatabine ameliorates disease in a model of Hashimoto's
thyroiditis. The results of the trial show that dietary
supplementation with anatabine induces a statistically significant
reduction in thyroid autoimmunity. We believe that continued
supplementation (beyond the three months of this study) will show a
progressive improvement in overall autoimmune responses."
The "Early Release" manuscript is currently available and may be
obtained by clicking the following link:
http://jcem.endojournals.org/content/early/recent
Certain statements contained in this release constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to statements identified by words such as
"believes," "expects," "anticipates," "estimates," "intends,"
"plans," "targets," "projects" and similar expressions. The
statements in this release are based upon the current beliefs and
expectations of our company's management and are subject to
significant risks and uncertainties. Actual results may differ from
those set forth in the forward-looking statements. Numerous factors
could cause or contribute to such differences, including, but not
limited to, results of clinical trials and/or other studies, the
challenges inherent in new product development initiatives,
including the continued development and market acceptance of our
nutraceutical dietary supplements products, the effect of any
competitive products, our ability to license and protect our
intellectual property, our ability to raise additional capital in
the future that is necessary to maintain our business, changes in
government policy and/or regulation, potential litigation by or
against us, any governmental review of our products or practices
and the outcome of the ongoing investigations as well as other
risks discussed from time to time in our filings with the
Securities and Exchange Commission, including, without limitation,
our annual report on Form 10-K for the fiscal year ended
December 31, 2012 and our quarterly
reports on Form 10-Q for the quarters ended March 31, 2013 and June
30, 2013. We undertake no duty to update any
forward-looking statement or any information contained in this
press release or in other public disclosures at any time.
About Star Scientific
Star Scientific, Inc. is a technology-oriented company with a
mission to promote maintenance of a healthy metabolism and
lifestyle. Through its wholly owned subsidiary, Rock Creek
Pharmaceuticals, Star Scientific has been engaged in the
manufacturing, sale, and marketing of two nutraceutical dietary
supplements, cosmetic products, and the development of other
nutraceuticals and pharmaceuticals. The company also continues to
pursue the licensing of the technology behind its proprietary
StarCured® curing process and its related products. Rock Creek
Pharmaceuticals has scientific and research offices in Gloucester, MA, and a regulatory office in
Washington, DC. Star Scientific
has a Corporate and Sales Office in Glen
Allen, VA, and an Executive, Scientific & Regulatory
Affairs office in Washington,
DC.
Contact:
Talhia T. Tuck
Vice President, Communications and Investor Relations
Star Scientific, Inc.
(202)887-5100
ttuck@starscientific.com
SOURCE Star Scientific, Inc.