Star Scientific Announces Successful First Look at the "Flint" CRP Human Study
and Provides Updated Report on ASAP Human Thyroid Study
GLEN ALLEN, Va., Oct. 24, 2012
GLEN ALLEN, Va., Oct. 24, 2012 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ:
STSI), announced today that the Roskamp Institute has reported positive
findings in its analysis of 100 subjects who completed the "Flint" CRP study
that analyzes the effects of dietary supplementation with Anatabloc® in
humans. The Company is also reporting additional information relating to its
ASAP human thyroid study.
(Logo: http://photos.prnewswire.com/prnh/20120301/NE62741LOGO )
"Flint" CRP Study
The "Flint" study titled, "A Single-blind, Multi-site Trial of the Dietary
Supplement Anatabine (RCP006) to Determine the Effects on Peripheral Markers
of Inflammation in Patients with Elevated Levels of C-reactive Protein (CRP)",
is a multi-site study of the safety, tolerability, dosing, and biological
effects of the anatabine citrate used in Rock Creek Pharmaceutical's
Anatabloc® product. Subjects in the study are individuals with high levels of
C-reactive protein (CRP) in the blood, which is a marker of systemic
inflammation in a number of common medical conditions. The subjects were
screened for eligibility and then were studied for three months. In the first
month they were given placebo, in the second month they were given the
Anatabloc® supplement, and in the third month they were given placebo again.
Blood samples were taken at the beginning of the study and also were taken
after each treatment period. The blood samples were analyzed for CRP,
anatabine, multiple markers of inflammation referred to as interleukins
(cytokines), as well as routine clinical labs for safety. The intent of the
study is to determine if the Anatabloc® supplement is helpful in lowering CRP.
The committee reviewing the data found that the administered doses of
anatabine were safe, well-tolerated, and showed clear evidence of a biological
effect on CRP and the immune system, as manifested by CRP and an inflammatory
marker called Tumor Necrosis Factor Alpha (TNF-alpha). The committee also
found a signal that the supplement may have an important effect in the most
common form of adult onset diabetes. Anatabine citrate, the active ingredient
in Anatabloc®, is found in common food plant species and is a natural compound
that activates the Alpha7 nicotinic acetylcholine receptor. Alpha7 receptors
are believed to be important in a number of inflammatory conditions, including
the characteristic systemic inflammation seen in diabetes.
The subjects who showed relative reductions in CRP were diabetics on
metformin, the most common drug used to treat diabetes. The diabetics were
twice as likely to have a reduction in CRP levels, as compared with other
subjects in the "Flint" study who had other non-diabetes medical disorders.
After one month of supplementation, CRP levels dropped in 26% of the subjects
with diabetes, compared with a drop in CRP levels in 12% of the general trial
population of subjects who did not have diabetes. The goal of the study was
to find specific sub-populations in which the Anatabloc® supplement might be
of benefit; therefore, this finding, though based on a small number of
diabetics (18 in the total study population), is very encouraging. The
investigators are currently evaluating whether to modify the rest of the study
or conduct a study focused on diabetes.
Elevated CRP is predictive in other studies for the onset of both metabolic
syndrome as well as overt diabetes, and elevated CRP is a significant risk
factor for cardiovascular disease both in diabetics and non-diabetics.
Lowering CRP would be strong evidence of a potential benefit in reducing the
inflammatory component in adult onset diabetes, an epidemic problem in the
Dr. Michael Mullan, MD, PhD, of the Roskamp Institute that sponsored the
study, said, "We are still looking at the data to define which interleukins
are most strongly affected, but when we conducted the CRP breakout analysis by
disease, the late onset diabetics showed a strong statistical trend to have
lower CRP with anatabine treatment compared to the non-diabetics. It will take
more work beyond this interim look to confirm this in a larger sample."
464 subjects have been screened for the "Flint" study, and 117 subjects have
completed the study.
Rock Creek Announces Update on Multi-Site Clinical Trial Studying Anatabloc®
Formulation and Thyroid Health
Rock Creek Pharmaceuticals has additional information to report on its "ASAP"
(Anatabloc Supplementation Autoimmune Prevention) thyroid study in humans. The
150 patient study titled, "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", is fully enrolled
and expected to complete in December of this year. The purpose of the study is
to investigate the potential role of Anatabloc® formulations for nutritional
supplementation in supporting the health of the human immune system. The ASAP
thyroid study was planned as a human follow-up of a successful animal study,
"Anatabine Ameliorates Experimental Autoimmune Thyroiditis, Endocrinology.
2012 Sep; 153 (9):4580-7." In the initial animal study, mice receiving
anatabine had lower incidence and severity of experimental autoimmune
thyroiditis, lower anti-thyroid antibody levels, and lesser declines in serum
thyroxine as compared with untreated mice.
The research, which has moved from analyzing animals to analyzing humans, was
designed to see if any of the changes observed in the mice could be observed
in subjects with autoimmune thyroiditis. A per-protocol, scheduled, blinded
(Treatment A v. Treatment B), interim look was recently completed, with data
available for approximately 48 of the 165 randomized subjects at the time of
the interim look.
The raters who reviewed the data agreed that there were sufficiently large
enough inter-treatment differences, in both anti-thyroid antibody and
interleukins, that the study was likely to reach its designed objectives. The
statistical team that conducted the interim look recommended continuing the
study as planned, and the Company anticipates completion and data base lock in
Dr. Curtis Wright, MD, MPH, Senior Vice President and Medical/Clinical
Director of Rock Creek Pharmaceuticals Inc., stated, "I am greatly encouraged
about the findings in the Flint study, which are consistent with other
information about anatabine in diabetes, and the interim look in the Thyroid
Paul L. Perito, Esq., Rock Creek's Chairman and CEO commented, "We are pleased
with the progress of the thyroiditis study and remain optimistic about the
final analysis, which we anticipate will be concluded during the fourth
quarter." Perito further commented, "Anatabloc® is available in GNC stores in
all 50 states and online at www.anatabloc.com."
To date, 230 subjects have been screened for the ASAP study and enrollment is
complete with 100 subjects having completed the study.
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, the challenges inherent in new
product development initiatives, including the continued development and
market acceptance of our nutraceutical and low-TSNA tobacco 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, including with respect to our
nutraceutical and low-TSNA tobacco products, 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, as well as to reduce the harm
associated with the use of tobacco at every level. 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 has continued to pursue the development,
implementation, and licensing of the technology behind its proprietary
StarCured® tobacco curing process, which substantially prevents the formation
of carcinogenic toxins present in tobacco and tobacco smoke, primarily the
tobacco-specific nitrosamines, or TSNAs and related low-TSNA dissolvable
tobacco 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; Executive,
Scientific & Regulatory Affairs offices in Bethesda, MD, and Washington, DC;
and a manufacturing facility in Chase City, VA.
Talhia T. Tuck
Vice President, Communications and Investor Relations
Star Scientific, Inc.
(202) 887-5100 firstname.lastname@example.org
SOURCE Star Scientific, Inc.
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