Star Scientific, Inc./Rock Creek Pharmaceuticals Report Positive Initial Results of ASAP Human Thyroid Health Study Showing

   Star Scientific, Inc./Rock Creek Pharmaceuticals Report Positive Initial
 Results of ASAP Human Thyroid Health Study Showing Benefits in Immune System
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PR Newswire

GLEN ALLEN, Va., Jan. 7, 2013

GLEN ALLEN, Va., Jan. 7, 2013 /PRNewswire/ --Star Scientific, Inc. (NASDAQ:
STSI) announced today the preliminary results of the Company's ASAP (Anatabloc
Supplementation Autoimmune Prevention) Human Thyroid Study that analyzes the
impact of anatabine dietary supplementation on thyroid health.

(Logo:http://photos.prnewswire.com/prnh/20120301/NE62741LOGO )

The study is a three-month, five-visit, double-blind, placebo-controlled study
of the impact of anatabine dietary supplementation in humans with autoimmune
disease of the thyroid. The study was conducted at nine sites and builds upon
previous epidemiological and animal experimental studies. 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.

Subjects in the study were screened initially to establish the presence of
active autoimmune thyroid inflammation. Baseline thyroid sonography, thyroid
antibody levels, and cytokine levels were collected from the subjects who were
determined to have active autoimmune thyroid inflammation. Thyroid function
tests and routine safety monitoring were also done in these subjects.
Eligible subjects were enrolled in the study and then received
weight-appropriate doses of anatabine or placebo, ranging from nine to
twenty-four mg of the anatabine supplement or placebo per day. Subjects
received treatment for three months, returning at four-week intervals for
repeat laboratory testing and/or sonography of the thyroid.

One-hundred forty-eight subjects completed the study, of which one-hundred
forty six complied with all treatment, visits and required tests. 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 full report of the study is still being completed and will soon be
submitted for peer review. Therefore, it is unavailable at this time.
However, these promising initial results prompted Curtis Wright, MD, MPH,
Medical Director of Rock Creek Pharmaceuticals, to comment, "It is remarkable
that dietary supplementation is able to help lower the thyroid antibody
activity. To see antibodies that may have been elevated for years beginning
to come down in a significant way after three months of supplementation is
exciting. Given the rate of decline over three months, it is quite reasonable
to expect that the effect may continue with longer use, which has already been
observed in individual cases. I look forward to following subjects over a
longer period in order to establish how profound and clinically meaningful the
effect is going to be. The thyroglobulin levels in some patients returned
entirely to normal in this three month study."

Dr. Paul Ladenson, senior endocrinological consultant for the study, stated,
"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.Current treatment for autoimmune thyroiditis is limited to end-stage
disease when irreversible gland damage necessitates lifelong thyroid hormone
replacement. The prospect of a novel nutritional or pharmaceutical
intervention that could preserve thyroid health represents an encouraging
advance. Further clinical studies are now warranted."

The title of the study is, "A Multi-Site, Double-Blind, Randomized,
Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Potential
Effects of the Dietary Supplement Anatabine on Antithyroid Autoantibodies and
Thyroid Function in Subjects with Autoimmune Thyroiditis". The full study
report will be available after all secondary analyses have been completed and
is planned to be submitted for scientific presentation and publication later
in the year.

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
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, 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, 2011. 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. Over the last
several years, through its wholly owned subsidiary, Rock Creek
Pharmaceuticals, Star Scientific has been engaged in the manufacturing, sale,
and marketing of two nutraceutical dietary supplements, 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.

Website: http://www.starscientific.com
 
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