Star Scientific and Rock Creek Pharmaceuticals Report on the Beneficial
Nutritional Effects of Anatabine in an Animal Model of Ulcerative Colitis
GLEN ALLEN, Va., March 19, 2013
GLEN ALLEN, Va., March 19, 2013 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ:
STSI), through its wholly owned subsidiary, Rock Creek Pharmaceuticals, Inc.,
announced today that it has received positive preliminary results from a study
investigating the effects of anatabine in an animal model of idiopathic
inflammatory bowel disease, Crohn's disease and ulcerative colitis. This
study, performed by researchers in the Department of Medicine at the
University of Virginia, assessed the effects of anatabine administration on
clinical and histologic manifestations of colitis in a mouse model of colonic
inflammation that has many features of a major form of human inflammatory
This animal model of inflammatory bowel disease, in which bowel inflammation
is induced in mice by the administration of a chemical known as DSS (dextran
sodium sulphate) in the drinking water, was chosen because it is a very well
established and highly reproducible model of colonic inflammation. More
importantly, this model allowed for an examination of the effect of anatabine
on the development and severity of inflammation (colitis prevention), as well
as on the recovery from inflammation and repair of tissue damage (colitis
Preliminary results from the prevention phase of the study showed that animals
given anatabine in their drinking water had a statistically significantly (p <
0.05) lower score in the primary clinical disease activity index as compared
to the score of mice receiving only DSS. The disease activity index is the
summation of scores from three parameters assessed daily: weight loss, stool
consistency, and blood in the stool (hematochezia). Lower scores represent
lower levels of disease activity. Anatabine treatment significantly reduced
diarrhea and watery stool during induction of the inflammatory condition.
Anatabine supplementation after inflammation was established was less
conclusive because mice in both the anatabine and control groups decreased the
amount of water they drank by almost 50% during the first few days of the
recovery regimen. Therefore, the amount of anatabine received by the
anatabine treated group of mice was much lower than intended during recovery.
The initial results of this study suggest that anatabine dietary
supplementation may prevent the recurrence (flare up) of ulcerative colitis or
reduce the severity of symptoms in vulnerable individuals. Although the
results from the longer-term treatment phase of the study were inconclusive,
the significant reduction in clinical manifestations of some features of bowel
inflammation with preventative treatment suggests that anatabine
supplementation may interfere with the excessive and prolonged production of
inflammatory molecules that leads to these clinical outcomes. Work at the
University of Virginia is ongoing to determine whether anatabine
administration interfered with the expression of pro-inflammatory cytokines
and other markers of inflammation in gastrointestinal tissue samples. Based
on the initial primary results of this pre-clinical study, a study of the
safety and effects of anatabine supplementation in human ulcerative colitis
may be warranted.
Dr. Curtis Wright, Medical and Clinical Director of Rock Creek
Pharmaceuticals, said, "Animal models of human disease are not always
predictive of benefits in humans, but when individual patient reports are
consistent with an animal model in a controlled laboratory study the findings
reinforce each other. We provided the study materials and appropriate funding
to the University of Virginia in support of the investigators' interest in
this area, and are very pleased with the results, which are consistent with
the individual case reports of benefit we have received from physicians and
patients describing their experiences with Anatabloc®. We hope the University
may consider that the time has come for a human clinical trial and we will
follow their research closely."
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 and
any governmental review of our products or practices, 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. 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 Scientifichas been engaged
in the manufacturing, sale, and marketing of two nutraceutical dietary
supplements, a cosmetic facial cream, 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.
Talhia T. Tuck
Vice President, Communications and Investor Relations
Star Scientific, Inc.
SOURCE Star Scientific, Inc.
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