GLEN ALLEN, Va., April 26, 2012 /PRNewswire/ -- Star Scientific,
Inc. (NASDAQ: CIGX) through its wholly owned subsidiary, Rock
Creek Pharmaceuticals, Inc., announces that it has received IRB
approval of the first human clinical study of the safety and
effects of nutritional supplementation with Anatabloc® in
individuals with Alzheimer's disease. The study will be
undertaken in conjunction with the Roskamp Institute of
Sarasota, Florida, which has been
acting as a research partner in assessing the impact of Anatabloc®
on Alzheimer's.
(Logo:
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This study developed out of Roskamp's earlier research work
published in the European Journal of Pharmacology (Paris D et
al. Anatabine lowers Alzheimer's AB production in vitro and
in vivo, Eur J Pharmacol. 2011 Nov 30;670(2-3):384-91) and
multiple reports of use of the supplement in users with Alzheimer's
disease. Both Rock Creek's and Roskamp's medical teams agreed that
enough preliminary data was now available to initiate the
study.
The study, entitled "A Three Month, Single-Site or Multi-Site,
Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial
to Evaluate the Safety, Tolerability and Potential Effects of the
Dietary Supplement Anatabine in Subjects with Alzheimer's Disease"
is a six-visit, double-blind, randomized, placebo-controlled,
parallel-group trial to evaluate the safety, tolerability, and
potential effects of anatabine dietary supplementation in subjects
with mild to moderate Alzheimer's disease (AD). Secondary
aims are to evaluate the effects of this specially formulated
version of Anatabloc® (patent pending) on amyloid beta (AB), global
outcome, and functional measures of AD. Although the Roskamp
Institute will be the primary study site, it is anticipated other
sites may be added as needed to fulfill enrollment goals. The
study will enroll subjects at least 65 years of age with a
diagnosis of mild to moderate Alzheimer's disease, and it is
expected that a minimum of 120 subjects will complete the
trial.
Dr. Ryan Lanier, Chief Clinical
Scientist for Rock Creek Pharmaceuticals, who coordinated the
development of the study protocol, commented, "The Roskamp
Institute has done its usual thorough job in working with Rock
Creek to design a study that will begin to bring definitive answers
to whether supplements of this class are tolerable and have
demonstrable effects in supporting the medical treatment of
individuals with this terrible condition. In answering calls from
physicians looking for ways to support their patients suffering
from Alzheimer's, it has been intensely frustrating to tell them
that we are preparing for such a study, but have to complete the
preliminary work to support a study in this population. Doing
good science takes time and patience, but I am very glad we have
the data needed to get started. The work done by Roskamp to date
has been of world-class quality and I am confident that the same
quality will continue in its role as the primary site for the
Alzheimer's study. We will do everything we can to support
the Roskamp Institute in that effort."
Rock Creek Pharmaceuticals and the Roskamp Institute have worked
collaboratively on research relating to the company's anatabine
compound for a number of years, occasioned by the Institute's
interest in the effect of the compound on immune system
support. Inflammation and the proper or aberrant functioning
of the immune system is a critical factor in a number of
neurological disorders studied by the Institute, and helping the
immune system regain its natural balance through nutrition is one
path toward supporting current medical treatments for such
conditions.
Paul L. Perito, Rock Creek's
Chairman and CEO stated, "I have waited a long time for this
pivotal event, with considerable anticipation. We strongly
believe that our nutritional products will be of value to
physicians in providing optimal care for their patients, and I'm
going to make sure that we do everything we can to get this study
done as fast as possible."
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 is a technology-oriented company with a mission to
reduce the harm associated with tobacco at every level. It is
engaged in the development of dissolvable smokeless tobacco
products that deliver fewer carcinogenic toxins, principally
through the utilization of the innovative StarCured® tobacco curing
technology. Its subsidiary, Rock Creek Pharmaceuticals, Inc., is
involved in the development of nutraceuticals as well as products
to address neurological and mood disorders. 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, an Executive, Scientific &
Regulatory Affairs office in Bethesda,
MD, and a manufacturing facility in Chase City, VA.
Contact:
Curtis Wright, IV, MD/MPH
Medical/Clinical Director and
Sr. Vice President of Rock Creek Pharmaceuticals, Inc.
(978) 283-1372
or
Talhia T. Tuck
Vice President, Communications and Investor Relations
Star Scientific, Inc.
(301) 654-8300
ttuck@starscientific.com
SOURCE Star Scientific, Inc.